Category: Healthcare

Viatris to Acquire Pacira BioSciences for $1.65 Billion, Expanding Into Non-Opioid Pain Therapies

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Viatris (Nasdaq: VTRS) announced Thursday it has agreed to acquire Pacira BioSciences (Nasdaq: PCRX) for $36.50 per share in cash, an aggregate equity value of $1.65 billion. The deal gives Viatris two marketed, patent-protected non-opioid pain medicines and positions the company as a leader in a category where patients and physicians continue to look for alternatives to opioids.

Pacira’s portfolio rests on EXPAREL, a long-acting local anesthetic used to manage pain after surgery, and ZILRETTA, an extended-release injection for osteoarthritis knee pain. Company materials cite up to a 78% decrease in opioid consumption with EXPAREL, though the release notes the clinical benefit of that reduction was not demonstrated. Over the twelve months ended June 30, 2026, Pacira generated about $746 million in revenue and $177 million in adjusted EBITDA. On equity value alone, the price works out to roughly 2.2 times revenue and 9.3 times adjusted EBITDA. GAAP net income over the same period was a much smaller $14.6 million, reflecting significant amortization of acquired intangibles and stock-based compensation.

Viatris says the acquisition advances its push to build an innovative medicines business, and that the products complement its fast-acting meloxicam opportunity in pain. The company also gains Pacira’s U.S. commercial, market access, medical affairs, and research capabilities, along with a pipeline led by a Phase 2 gene therapy candidate for knee osteoarthritis. Viatris plans to apply its expertise in intellectual property and product lifecycle management to extend the portfolio’s reach, including across select international markets where it already operates.

Viatris expects to fund the deal primarily from excess cash, with the remainder from short-term borrowings, and says the impact on its gross leverage ratio will be minimal. The transaction is expected to be immediately accretive to its financial guidance metrics. It will be structured as a tender offer followed by a second-step merger at the same price, with both boards having unanimously approved and Pacira’s board recommending that shareholders tender. Closing requires that a majority of Pacira’s outstanding shares be tendered and that the regulatory waiting period expire, and is expected by the end of 2026. Once complete, Pacira will be delisted from Nasdaq. Viatris will discuss the transaction when it reports third-quarter results on November 5.

Pacira’s leadership said the company has helped nearly 20 million patients access non-opioid pain management and that Viatris’ scale and resources will help bring its therapies to more patients.

The thesis behind the deal is worth examining. Viatris highlighted its record of sustaining sales after competition arrives, a reminder that protected products do not stay protected forever and that part of what Viatris is paying for is its ability to manage that transition.

For small and microcap investors, the takeaway is that commercial-stage healthcare companies with profitable, differentiated products are drawing strategic interest at disciplined valuations. Roughly nine times adjusted EBITDA on equity value is a useful benchmark for smaller specialty pharma and medical technology companies with established revenue, and it reinforces a theme running through this year’s healthcare deal activity, including Supernus’s merger with Indivior and MiMedx’s acquisition of Sanara MedTech. Companies still in development are a different proposition, since their deal values depend far more on clinical milestones than on current earnings.

Take a moment to take a look at more emerging growth biotech companies by looking at Noble’s Research Analyst Robert LeBoyer’s coverage list.

MAIA Biotechnology (MAIA) – Patient Enrollment Completed In THIO-101, Enrollment Milestone Reached In THIO-104

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Thursday, October 08, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

MAIA Reported Two Important Clinical Trial Milestones. MAIA announced the completion of enrollment for the Part C Expansion Stage of the THIO-101 trial. This part of THIO-101 has enrolled 150 patients. Separately, the Phase 3 THIO-104 trial reached enrollment of 65 patients, putting it on schedule to enroll 100 patients by YE2026. Reaching the full-year enrollment goal could allow an interim analysis in FY2027.

Results From THIO-101 Part C Have Been Positive To Date. As discussed in our Research Note on September 22, MAIA recently announced initial efficacy data from the THIO-101 Part C. The evaluable population, consisting of patients with at least one post-treatment evaluation by tumor scan, showed a disease control rate (DCR) of 90.5%. This far exceeds published studies that show a 25%–35% DCR for standard third-line chemotherapy regimens.


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Gate Bioscience Expands Its Lilly Deal to More Than $870 Million, Adding a New Drug Target

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Gate Bioscience, a privately held drug discovery company, announced Monday that it has expanded its research and licensing agreement with Eli Lilly (NYSE: LLY) in a deal now potentially worth more than $870 million. The original agreement, announced in July 2025, was worth up to $856 million. The expansion adds one drug target, with an option to add a second.

Gate will receive an upfront payment and research funding for the added target, plus an additional payment if the second target is selected. Neither company disclosed the size of the upfront payment. Gate is also eligible for milestone payments and royalties on global sales of any products that result.

The science behind the partnership takes a different approach to disease. Gate uses its platform to discover oral small-molecule drugs designed to eliminate proteins that have been difficult to target with existing medicines. Many conventional drugs work by blocking a protein’s activity, but some disease-driving proteins offer no good place for a drug to bind. A drug built to remove the protein altogether can reach targets once considered out of reach.

The two companies have split the work along familiar lines. Gate leads discovery, while Lilly takes over late-stage preclinical and clinical development, manufacturing, and commercialization. Lilly holds exclusive worldwide rights to products developed against the selected targets.

The deal fits a pattern in Lilly’s strategy this year. The company has acquired Merida Biosciences, which is developing biologics that eliminate disease-causing autoantibodies, and AtaiBeckley, a clinical-stage mental health company, while also signing earlier-stage platform partnerships like this one. Buying finished assets and renting promising discovery engines are two ways of filling the same pipeline.

The headline number deserves context. The expansion lifts the potential value by only about $14 million over the original agreement, which shows how these figures work. Partnership values are usually quoted at their maximum, with most of the money tied to development and sales milestones that may never be paid. The undisclosed upfront payment is the figure that actually reaches the company’s balance sheet.

The same partnership playbook is open to smaller companies pursuing oral small-molecule medicines. Cocrystal Pharma, which uses a structure-based discovery platform to develop antiviral drugs, and Cardiff Oncology, whose lead candidate onvansertib is an oral small molecule being studied in colorectal cancer, work in different therapeutic areas than Gate, and neither focuses on protein elimination. But both illustrate the model investors are watching: a differentiated discovery approach or oral drug candidate that could eventually attract a larger development partner.

For investors tracking small and microcap biotech, the takeaway cuts both ways. Large pharma remains willing to sign collaborations worth hundreds of millions of dollars with private platform companies before any drug reaches the clinic, a sign of continued appetite for differentiated discovery technology. But a platform deal is not an approved product. The upfront cash, the pace of milestone payments, and whether the partner keeps selecting targets matter most, and investors weighing smaller developers with similar partnership ambitions should read the fine print on all three.

Release – GeoVax Highlights Likely Sustained Clade Ib Mpox Transmission in the United States

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GeoVax, Inc.

Research News and Market Data on GOVX

CDC Reports Changing U.S. Transmission Dynamics Underscore Importance of Continued Surveillance, Vaccine Preparedness and Resilient MVA Vaccine Supply

ATLANTA, GA – September 29, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines against infectious diseases and therapies for solid tumor cancers, today highlighted an important change in the U.S. epidemiology of Clade I mpox reported by the U.S. Centers for Disease Control and Prevention (CDC).

In its September 25 update, CDC reported more than 60 laboratory-confirmed Clade I mpox cases across at least 20 U.S. states. Since August, an increasing proportion of U.S. Clade I cases have occurred among individuals with no recent international travel or known links to recent travelers. Cases with presumed domestic transmission have now been reported in more than 10 jurisdictions, which CDC said indicates a “likely transition to sustained Clade Ib transmission in the United States.” CDC continues to assess the risk from the Clade I outbreak as low for most people in the United States, while noting that additional travel-related and domestically acquired Clade Ib cases are expected.

David Dodd, Chairman and Chief Executive Officer of GeoVax, commented: “CDC’s latest assessment represents an important change in the epidemiology of Clade Ib mpox in the United States. While the risk to the general population remains low, presumed domestic transmission across multiple jurisdictions reinforces the importance of continued surveillance, vaccination of appropriate at-risk populations and sustained preparedness.”

Dodd continued: “Preparedness should not begin when an infectious-disease threat becomes a crisis. The appropriate time to strengthen vaccine capacity, diversify sources of supply and establish scalable manufacturing infrastructure is before those capabilities are urgently needed. The changing geographic footprint and public health threat of mpox is another reminder that infectious diseases do not respect national borders.”

Advancing GEO-MVA as a Potential Additional MVA Vaccine Option

GEO-MVA is GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine being developed for protection against mpox and smallpox. Following formal guidance from the European Medicines Agency (EMA), GeoVax is advancing GEO-MVA through an expedited clinical development pathway, with traditional Phase 1 and Phase 2 clinical trials not required, allowing the program to proceed directly to a pivotal Phase 3 immunobridging study comparing immune responses generated by GEO-MVA with those generated by the licensed MVA-BN comparator. GeoVax expects to initiate the 500-participant pivotal Phase 3 immunobridging study in the fourth quarter of 2026, with results expected in mid-2027, having completed the manufacturing/fill-finish and clinical operations aspects in support of initiating and completing the pivotal study.

GeoVax is developing GEO-MVA to expand global access to MVA vaccines and scalable production capabilities, with the potential to provide governments and international public health organizations with an additional source of MVA vaccine. The Company believes GEO-MVA can become an important strategic preparedness asset by supporting diversified vaccine supply, scalable manufacturing capacity and greater supply resilience, while strengthening biosecurity, orthopoxvirus preparedness and the ability to respond to evolving global health threats.

Dodd concluded: “Low risk to the general population today and the need for long-term preparedness are not contradictory. CDC’s latest assessment illustrates why preparedness must anticipate changes in infectious-disease transmission rather than react to them after they occur. We believe diversified vaccine supply and scalable MVA manufacturing capacity can become increasingly important as the epidemiology of mpox continues to evolve.”

A Changing Mpox Landscape

The development is particularly noteworthy because the 2022 global mpox outbreak, including the large U.S. outbreak, was caused by Clade IIb. Clade I mpox has historically been associated with more severe disease and higher mortality than Clade II. However, disease severity varies by viral subclade, population and access to medical care. Recent Clade Ib cases identified in high-income countries have generally involved relatively mild illness, underscoring the importance of distinguishing the changing epidemiology of the virus from the immediate risk it poses to the general population.

The significance of CDC’s latest assessment therefore extends beyond disease severity alone. The emergence of likely sustained Clade Ib transmission represents an important change in the geographic footprint and transmission dynamics of mpox in the United States. The new CDC assessment also represents an evolution from earlier U.S. surveillance. As recently as August, CDC reported that sustained Clade Ib transmission had not been detected in the United States during 2024–2025. The September 25 assessment now indicates a likely transition toward sustained domestic transmission.

Globally, Clade I outbreaks have continued in Central and Eastern Africa since late 2023, with subsequent geographic expansion beyond the region, including transmission in parts of Europe and introductions into the United States. The evolving epidemiology follows other recent public-health preparedness actions, including updated CDC vaccination recommendations for certain U.S. travelers at increased risk and international initiatives to strengthen access to mpox vaccines and outbreak-response capabilities.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected]

Release – NanoViricides, Inc. Has Filed its Annual Report: Broad-spectrum Antiviral NV-387 Is In Phase II Clinical Trials

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Research News and Market Data on NNVC

Tuesday, 29 September 2026 08:45 AM

Topic: 

Company Update

SHELTON, CT / ACCESS Newswire / September 29, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), reports that it has filed its Annual Report on Form 10-K for the fiscal year ending June 30, 2026 with the Securities and Exchange Commission (SEC) on Monday, September 28, 2026. The report can be accessed at the SEC website (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001379006/000110465926111390/nnvc-20260630x10k.htm).

Accomplishments in Reported Fiscal Year ending June 30, 2026

In the fiscal year 2026, we have achieved a substantial level of accomplishments. We have focused on regulatory advancement of our broad spectrum antiviral drug NV- 387.

We received approval for Phase II clinical trial to evaluate the safety and efficacy of NV-387 Oral Gummies for the treatment of Mpox in September, 2025, from the regulatory agency ACOREP in the Democratic Republic of Congo (DRC). Unfortunately, the MPox Clade I epidemic that led WHO to declare a Public Health Emergency of International Concern (PHEIC) in August, 2024, had substantially abated in the Kinshasa region. We therefore chose a remote site where Mpox cases were still prevalent. We had to upgrade the facilities at this site including patient isolation facilities as well as laboratory facilities significantly to enable conducting the clinical trial there.

This Phase II clinical trial began enrollment at the end of September, 2026.

Meanwhile, in May 2026, WHO declared a PHEIC for the Ebola Bundibugyo virus disease outbreak that had just begun in the Ituri province. There is no approved treatment nor an approved vaccine for this virus. Moreover, this Bundibugyo virus (BDBV) differs significantly from previous Bundibugyo viruses that caused outbreaks, as well as from other Ebola viruses.

Subsequent to the reporting period, in July, 2026, we applied for regulatory approval to conduct a Phase II clinical trial to evaluate he safety and efficacy of NV-387 Oral Gummies for the treatment of Ebola virus disease (any Ebola virus). In August, 2026, we received the approval for this Phase II clinical trial of NV-387 from ACOREP in DRC.

This Phase II clinical trial also began enrollment at the end of September, 2026 at an Ebola Treatment Center in Ituri province.

The current Ebola outbreak in DRC is rapidly growing.

As of September 23, 2026, there have been 7,890 confirmed cases, 3,799 confirmed deaths, and 1,966 confirmed recoveries in DRC, according to the WHO daily report i. In comparison, as of August 14, 2026, there were reported 4,945 confirmed cases and 2,325 confirmed deaths due to this virus. The crude fatality rate (crude CFR) is about 48%, but the probability of an infected person dying is estimated at 67%ii.

In addition, we also began our efforts towards US FDA regulatory approvals for NV-387.

We applied for an Orphan Drug Designation (ODD) of NV-387 as a Treatment for Measles in February, 2026. Subsequently, we also applied for a Rare Pediatric Disease Drug (RPDD) designation for NV-387 as a pediatric Measles treatment.

The US FDA approved the ODD and the RPDD designation for NV-387 as a treatment of Measles in May and June, 2026, respectively.

In addition, we have continued process development work for the manufacture of NV-387. We have also worked on improved formulations of the NV-387 oral gummies.

Thus, we have made significant achievements towards regulatory approvals for NV-387 in the reported year.

NV-387 Would become an Important Medical Countermeasure for Combatting Several Difficult Viral Infections with Outbreak, Epidemic, and Pandemic Occurrences, if Approved

MPox Clade I and Clade II

There is no approved drug for the treatment of MPox, Clade I or Clade II. Tecovirimat, a drug approved by the US FDA under the “Animal Rule”, and stockpiled by the US Government in pandemic preparedness program for Smallpox bioterrorism, failed in clinical trials. Another drug, brincidofovir, also approved by the US FDA under the “Animal Rule”, and stockpiled by the US Government in pandemic preparedness program for Smallpox bioterrorism, is currently in clinical trial for MPox. First fifty randomized MPox patients (our assumption is possibly 25 in the brincidofovir arm and 25 in a control arm) were evaluated for safety and tolerability. No new safety signals (i.e. toxicities) were found according to a press release in January, 2026 iii. The brincidofovir prescribing information carries a black box warning and lists gastrointestinal toxicities and elevation of liver enzymes as major toxicities of the drug iv.

MPox Clade II has become endemic in the Western world after the global epidemic that began in Africa in 2022. It has remained primarily in the cohorts of men-having-sex-with-men (MSM) and their sexual contacts. MPox Clade II virus is difficult to transmit and is transmitted via contact with eroded MPox skin lesions and open bruises.

There were 999 cases of MPox (Clade I and Clade II together) in 2026, as of September 2, 2026, according to CDC. Cases of MPox Clade I are increasing in the USA, and those cases not related travel have begun to show up in the since August, 2026.

If sustained transmission of MPox Clade I occurs, it could lead to an outbreak in the USA, however, the probability is considered small. MPox Clade I is highly pathogenic, and also transmits more easily compared to Clade II. The case fatality rate of MPox Clade I is between 0.5% to 3%, whereas that for Clade II is less than 0.1% (above information compiled from CDC websitev).

CDC recommends two doses of JYNNEOS vaccine to protect from MPox. JYNNEOS was developed as a Smallpox vaccine. The effectiveness of this vaccine in MPox Clade II is limited, at 36% for one dose and 66% for 2 doses against the less pathogenic MPox Clade IIvi. The vaccine effectiveness is likely to be much less against the more severe MPox Clade I.

However, without a drug to treat a viral infection, vaccines alone are not sufficient, even if highly effective. Thus a drug to treat MPox is an unmet medical need.

NV-387 for treatment of MPox, if successful, has a strong financial potential.

Ebola and Marburg Viruses Family (Filoviruses)

There is no approved drug for the treatment of all Ebola and Marburg viruses. Two monoclonal antibodies are approved, and two vaccines are approved, but only for the EBOV Zaire version that caused the 2022 West Africa outbreak.

A clinical trial called “PARTNERS” is evaluating Infusion of MBP134, a monoclonal antibody cocktail, Infusion of Remdesivir, and Infusion of both, as a treatment for Ebola BDBV infection against standard treatment control group, in DRC.

Infusions are very difficult to administer in the BSL4-like isolation setting required for Ebola. Also, infusion even if approved, would not be scalable for administration to large number of patients in a large outbreak as is occurring in DRC at present.

NV-387 Oral Gummies, as an oral drug, has the ideal target product profile for fighting this Ebola outbreak.

Measles

There is no approved drug for Measles. NV-387 is the only drug candidate that has shown effectiveness against Measles virus in a lethal infection study in a humanized (hSLAM+knockin,IfnAR-/-) mouse model for the disease, to the best of our knowledge.

Measles cases and outbreaks are rising globally. In the USA, in 2026, as of September 24, 2026, there were 3,659 confirmed measles cases, one confirmed Measles infection death and additional three possibly Measles-related deaths were reported, according to the CDC and news reportsvii.

Our Strategy of NV-387 for Orphan Diseases of Pandemic Potential has Strong Financial Incentives and Potential for Early Revenues

Smallpox and MPox are important for the US Government from the perspective of pandemic preparedness and bioterrorism potential.

Likewise, Ebola and Marburg family of viruses is important for pandemic preparedness, and these are considered priority pathogens. A drug that can work against all of them would be sought after for acquisition at least by the US Government and potentially by several other governments.

If NV-387 is successful against either MPox or Ebola or both, there would be a strong case that USG agencies may provide non-dilutive funding for its regulatory approval, and upon approval, may acquire the drug for the Strategic National Stockpile (SNS) for preparedness.

SNS acquisition contracts have been in the range of high hundreds of millions per year.

NV-387 for Measles would be eligible, upon approval, for receiving a Priority Review Voucher (PRV) from the US FDA as a benefit of the RPDD designation.

A PRV can be sold and recent trades have fetched as much as $200 millionviii. The sale of PRV can fetch such revenues even before commercially meaningful revenues from sale of the drug can be developed, offering a strong incentive for our NV-387 for Measles drug development.

We believe that NV-387 is on its way to become a revolutionary antiviral therapy that could be prescribed for practically any respiratory viral infection without first testing for the causative virus, just as broad-spectrum antibiotics can be prescribed even before testing for the causative bacteria. This “empiric therapy” approach would enable immediate treatment and thus improve effectiveness; it is well known that antiviral treatments are most effective when given early.

NV-387 would play in a market size of well over $20 Billion as a dominant player, if approved for such empiric therapy of viral ARI/SARI.

To this end, we have proposed a novel adaptive, Phase II clinical trial for the evaluation of NV-387 as a treatment for Viral Acute/Severe Acute Respiratory Infections (V-ARI, V-SARI) towards this goal. A preliminary clinical protocol for this complex trial has been developed.

We plan on leveraging the MPox studies towards approval of NV-387 as a treatment of Smallpox under the US FDA “Animal Rule”. The US agency BARDA has programs to support such development if NV-387 qualifies.

Financials

We reported that, as of June 30, 2026, we had cash and cash equivalent current assets balance of approximately $2.79 Million. In addition, we reported approximately $6.40 Million in Net Property and Equipment (P&E) assets (after depreciation). The strong P&E assets comprise our cGMP-capable manufacturing and R&D facility in Shelton, CT, where we manufacture our clinical trial drug substance and drug products, thus producing substantial savings as compared to working with an external manufacturer (CDMO). The total current liabilities were approximately $1.19 Million. In comparison, as of June 30, 2025, we had cash and cash equivalent balance of approximately $1.67 Million, P&E assets of approximately $6.83 Million (after depreciation), and total current liabilities of approximately $1.31 Million.

The net cash utilized in the reported period for operating activities was approximately $7.70 million, which includes continuing expenditures for completion of the Phase Ia/Ib clinical trial of NV-387 in India, Clinical Trial Application for Phase II Clinical Trial of NV-387 as a Treatment for MPox in DRC, and R&D and preparatory work including cGMP manufacture of the drug substance for the Phase II clinical trial of NV-387 for treatment of MPox.

We raised approximately $7.10 million in sale of equity and warrants in registered direct offerings, and $1.91 million from sale of common stock in ATM equity offering, for a total financing of approximately $9.01 million during the reported period.

Subsequent to the reporting period, in July 2026, we raised approximately $3.8 million in gross proceeds from a registered direct offering comprising common stock and warrants to a single investor.

Further, our founder, Dr. Anil Diwan has provided a line of credit (LOC) of $3 million to the Company. We have not yet drawn on the LOC. As such, we reported that we do not have sufficient funding in hand as of now to continue operations through September 30, 2027, for our planned objectives. As a result substantial doubt exists about the Company’s ability to continue as a going concern, as evaluated based on applicable guidelines. We are actively exploring additional required funding through non-dilutive grants and contracts, partnering, debt or equity financing pursuant to our plan. We believe that the Company has on-going access to the capital markets including the “At-The-Market” (ATM) agreement that became active around July 17, 2026. We have previously adjusted our objectives and development plans on the basis of available resources and we will continue to do so.

We Have Several Important Milestones in the Ensuing Year

The Phase II Clinical Trial for the evaluation of NV-387 Oral Gummies as a Treatment for MPox: Commissioning of Enrollment and Dosing, Initial Results from Phase IIA (primarily safety and tolerability), Initial Results from Phase IIB (primarily efficacy), Reports Preparation and Submission. A Phase III Application will be undertaken if there continue to be sufficient number of MPox cases.

The Phase II Clinical Trial for the evaluation of NV-387 Oral Gummies as a Treatment for Ebola: Commissioning of Enrollment and Dosing, Initial Results from Phase IIA (primarily safety and tolerability), Initial Results from Phase IIB (primarily efficacy), Reports Preparation and Submission. A Phase III Application will be undertaken if there continue to be sufficient number of Ebola cases.

Pursuing Orphan Drug Designations for NV-387-for-MPox, NV-387-for-Smallpox, and NV-387-for-Ebola.

Filing of a pre-IND with the US FDA towards NV-387 for Smallpox treatment under the “Animal Rule”.

Filing of an IND with the US FDA towards evaluation of NV-387 as a Smallpox treatment leading to registration.

Filing of the Phase II Clinical Trial Application for the evaluation of NV-387 as a treatment for Viral Acute Respiratory Infections (Viral-ARI) in India, its Approval by the regulator, and Commissioning of the clinical trial, and Interim Results. This Phase II clinical trial is expected to yield data on the safety and efficacy of NV-387 for the treatment of Influenza, RSV, Coronaviruses, and hMPV, which are the most important seasonal epidemic/pandemic viruses, in a single clinical trial.

As we meet the milestones, we believe we will be able to raise financing for further regulatory activities for NV-387 registration via non-dilutive grant funding, partnership revenues, as well as equity-based funding.

More About Our Drug Pipeline

We believe the Company has a bright future. Our Phase II clinical stage drug NV-387 has completed Phase I clinical trial with the successful results that there were no drop-outs, and there were no reported adverse events, both of which clearly indicate excellent safety and tolerability in humans. NV-387, as mentioned above, is likely to become a revolutionary broad-spectrum antiviral therapeutic, that could change how we treat viral infections forever.

In addition, the Company has developed a pan-Herpesvirus drug, NV-HHV-1. Its skin cream formulation for the treatment of Shingles rash, Chickenpox, HSV-1 Cold Sores, and HSV-2 Genital Ulcers, has completed certain IND-enabling non-clinical studies. NV-HHV-1 has demonstrated effectiveness in a human skin model of VZV infection (Varicella-Zoster-Virus, which causes Chickenpox and Shingles). A systemic form of the herpesvirus drug is in development. The Company has also developed an anti-HIV drug, NV-HHV-1, which the HIV viruses would not be able to escape despite rapid virus evolution. NV-HHV-1 has demonstrated strong effectiveness superior to triple-drug combination HAART therapy in a humanized animal model of HIV infection.

The Nanoviricides™ Technology and Non-Clinical Animal Studies Results in Brief

The Company’s technology is based on mimicking the host-side binding sites that the virus uses which remain the same despite several and extensive changes in the virus. We design and make chemical mimics of these sites to create virus-binding ligands that we attach to a base polymer. This makes the drug look like a cell membrane to the virus. The nanoviricide drug is thus designed to fool the virus into entering the nanoviricide drug micelle and uncoating itself by using the virus’s own smarts against it.

We believe viruses would not be able to escape nanoviricide drugs because of this design. In contrast, viruses readily escape vaccines, antibodies, and most of the small chemical drugs.

Oral NV-387 was found to be superior to the three known drugs oseltamivir (Tamiflu®, Roche), peramivir (injection, Rapivab®, BioCryst), as well as baloxavir (Xofluza®, Shionogi/Roche) in a lethal lung infection animal model of Influenza.

Oral NV-387 was found to cure lethal lung RSV infection in an animal model. There is no current approved drug for treating RSV infection.

Previously, NV-387 given both orally and as I.V. injections was found to be substantially superior to remdesivir (injection, Gilead) in a lethal lung infection animal model for COVID-19.

Oral NV-387 was found to be equivalent to or superior than tecovirimat (TPOXX®, SIGA) in two different lethal animal models of orthopoxvirus diseases. One of these models simulated skin infection which is the primary route of MPox Clade II infections. Another animal model simulated direct lung infection which is the likely route of Smallpox infection in case of bioterrorism.

Oral NV-387 was found to be highly effective as a treatment of lethal Measles virus lung infection in humanized (hSLAM+knockin, IfnAR-/-) mice. There is no approved treatment for Measles.

About NanoViricides

NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.

Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.

The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides’ platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company’s pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.

This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to “Investigational New Drug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency’s (EMA) committee responsible for human medicines. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
[email protected]

Public Relations Contact:
[email protected]

i https://www.who.int/emergencies/alert-and-response , retrieved on Monday September 28, 2026 at 00:58 EDT. See also, https://www.cdc.gov/ebola/situation-summary/index.html.

ii The Crude CFR is calculated simply by dividing the confirmed deaths by the confirmed number of cases on the same reporting date. It ignores the fact that the deaths are actually occurring in patients that were confirmed infected several days earlier; i.e. the time lag of sickness is not accounted for in the crude CFR. If it is accounted for, the actual fatality rate per confirmed infection (Infected Fatality Rate or IFR) would be much higher than the crude CFR. For example, if one assumes an average time lag of 21 days (Aug 14 to Sept 5), then the IFR on September 5 would be (3,175/4,945 = ) 64%. Not all infections are reported or confirmed by lab tests; however, it is likely that most deaths are counted. This produces a large uncertainty in such CFR and IFR estimates. Another way to estimate IFR would be to simply take a ratio of confirmed deaths to that of confirmed deaths plus confirmed recoveries. This metric, probability of death, is more robust and insensitive to the lag times, except it ignores patients that are still in hospital. The p(death) based on this metric is (using Sept. 10 numbers,(3,398)/(3,398 +1,671) = 67%. That said, a number of cases as well as deaths remain unconfirmed or unreported because of the regional issues.

iii https://mpx-response.eu/a-first-safety-interim-analysis-of-mosa-shows-no-signal-of-safety-concerns-with-brincidofovir-a-potential-antiviral-to-fight-mpox/

iv brincidofovir TEMBEXA prescribing information, from US FDA website, https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214460s000,214461s000lbl.pdf.

v https://www.cdc.gov/monkeypox/index.html.

vi From the Mpox Emergency Response Team, CDC (2023-05) “Vaccine Effectiveness of JYNNEOS against Mpox Disease in the United States,” N Engl J Med 2023;388:2434-43.

vii https://www.cdc.gov/measles/data-research/index.html

see also https://www.usnews.com/news/us/articles/2026-09-18/us-cdc-works-on-standard-definition-for-measles-deaths-as-cases-rise.

viii https://prvwatch.com

SOURCE: NanoViricides, Inc.

Release – Unicycive Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum Carbonate

Posted on by [email protected]
Unicycive Therapeutics, Inc

Research News and Market Data on UNCY

September 29, 2026 7:05am EDT Download as PDF

  • Resubmission of NDA includes Chemistry, Manufacturing, and Controls (CMC) data from a new drug product manufacturing vendor 
  • The resubmission package includes 12 months of OLC drug product stability data from the new manufacturing vendor
  • Company anticipates FDA acceptance of the NDA within 30 days of resubmission; new assigned PDUFA date expected to be 6 months from resubmission
  • Current cash position allows runway into 2H 2027

MOUNTAIN VIEW, Calif., Sept. 29, 2026 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company’s investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The Company anticipates United States Food and Drug Administration (FDA) acceptance of the NDA within 30 days and a new assigned PDUFA date to be six months from the date of resubmission.

The NDA resubmission includes CMC data from a new third-party drug product manufacturing vendor. The new vendor’s facility was last inspected by the FDA in March 2024 and received “No Action Indicated” status, the highest FDA inspection classification indicating that a facility is in an acceptable state of current Good Manufacturing Practices (cGMP) compliance. The new vendor’s CMC data package includes technical specifications similar to the original third-party manufacturing vendor, and the new vendor has already produced OLC drug product and completed 12-month stability studies. In addition, the Company has provided additional in-vitro bridging data between the two vendors as recommended by the FDA in previous discussions.

In June 2026, the Company received a Complete Response Letter (CRL) from the FDA regarding the first OLC NDA resubmission. The 2026 CRL cited the same third-party manufacturing deficiencies identified in a previous CRL issued in June 2025 to the initial NDA submission, as a result of the FDA not having conducted the reinspection of the original third-party manufacturing vendor. The FDA did not raise concerns regarding clinical efficacy or safety data and did not request additional data from the Company. The Company’s original third-party manufacturing vendor has received written notification from the FDA that its facility inspection has been assigned, but the inspection has not yet occurred as of September 29, 2026. If the original third-party manufacturing vendor is inspected in the near term and deemed cGMP-compliant, the Company plans to seek FDA alignment on a shorter approval timeline for the OLC NDA resubmission. Unicycive intends to keep both drug product vendors to maintain supply chain redundancy.

“We believe this resubmission reflects an efficient path to potential approval and, if approved, a potentially faster path to bringing OLC to patients who need additional treatment options,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “By adding an alternative primary manufacturing vendor, we are positioning the NDA for expedient review and potential approval. If the FDA’s assigned inspection of the original vendor is completed favorably in the interim, that outcome could provide a potential timing benefit. We continue to advance commercial readiness activities in anticipation of a potential launch, with the goal of helping patients with CKD on dialysis who continue to struggle with hyperphosphatemia.”

The NDA is supported by data from three clinical studies: a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis, along with multiple preclinical studies and CMC data.

As of June 30, 2026, unaudited cash, cash equivalents and marketable securities totaled $61.4 million, supporting continued OLC commercial launch preparation and an expected cash runway into the second half of 2027.

About Oxylanthanum Carbonate
OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.1 Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

1Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; our dependence on third parties for manufacturing; the possibility that FDA may require inspection of any vendor prior to approval, which could delay or prevent approval of our NDA; the risk that the original third-party manufacturing vendor’s reinspection may not occur within a timeframe that benefits our regulatory timeline, or may result in adverse findings; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of our products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contacts:
Kevin Gardner
LifeSci Advisors
[email protected]

Media Contact:
Unicycive Therapeutics
[email protected] 

SOURCE: Unicycive Therapeutics, Inc.

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Source: Unicycive Therapeutics, Inc.

Released September 29, 2026

Ocugen (OCGN) – New Designations In The Bahamas To Lead To First Commercial Approval For OCU400

Posted on by [email protected]


Monday, September 28, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

First Commercialization Could Be Coming Soon. Ocugen has received Provisional Approval and Priority Designation from the Bahamian government for OCU400. Ocugen can now supply OCU400 through an Expanded Access Program (EAP). If the first patient is treated within 90 days, OCU400 will receive full regulatory approval, allowing for commercialization in Retinitis Pigmentosa (RP). We see this as a significant regulatory and commercial milestone.

Regulatory Approval Is More Significant Than Potential Sales. This would be the first approval to allow commercial sales of OCU400. While some countries allow compassionate-use treatments before approval at the company’s break-even cost, Ocugen will be allowed to charge full price and earn profit on the treatments. We expect only a handful of patients to be treated in the coming quarters and do not expect a material impact on quarterly Net Losses, as the company has three late-stage clinical trials in progress at this time.


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Release – NeuroSense Provides Business Update and Progress for the First Half of 2026

Posted on by [email protected]

Research News and Market Data on NRSN

CAMBRIDGE, Mass., Sept. 25, 2026 /PRNewswire/ — Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense” or the “Company”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today provided a business update with corporate highlights to date and financial results for the first half of 2026.

NeuroSense is advancing PrimeC, its investigational combination therapy for amyotrophic lateral sclerosis (ALS), through regulatory pathways in the United States and Canada while pursuing a focused, capital-efficient late-stage development strategy.

“Our focus remains on advancing PrimeC toward the next stage of development and, ultimately, toward patients,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “We are working diligently to move our development plans forward in a capital-efficient manner, while pursuing the regulatory, clinical, financing and strategic opportunities available to us. Looking ahead, our priorities include advancing our regulatory pathway in Canada, preparing for the next clinical stage of PrimeC in ALS, and pursuing the funding, partnerships and strategic alternatives that can support the continued development of the program. We remain fully committed to doing everything we can to realize PrimeC’s potential to address the significant unmet need in ALS.”

Upcoming Corporate Highlights for the Remainder of 2026 include:

  • Targeting December 2026 NDS filing in Canada – Following completion of the Pre-New Drug Submission process and finalization of meeting minutes with Health Canada, NeuroSense is preparing an NDS for PrimeC in ALS and is targeting December 2026 for submission. Health Canada indicated no concerns with the proposed filing timeline and provided alignment regarding the planned content and structure of the submission.
  • Advancing an optimized, capital-efficient U.S. development strategy – NeuroSense is working toward an optimized path for PrimeC that includes AI-enabled characterization of PrimeC’s proprietary formulation, a planned active-comparator study against edaravone, and evaluation of a smaller and shorter pivotal PARAGON design. The Company plans to discuss with the FDA whether the existing data may support full approval or, alternatively, an Accelerated Approval pathway. Any revised pivotal design or regulatory pathway remains subject to FDA alignment.
  • Continued financing and strategic initiatives – The Company continues to pursue financing opportunities, including potential non-dilutive funding sources, and evaluate a range of strategic alternatives, including potential business and corporate transactions, intended to provide the resources and strategic framework required to advance PrimeC, while prioritizing capital-efficient development and preserving long-term shareholder value.

2026 Corporate Highlights to Date

  • PARADIGM results published in JAMA Neurology and long-term survival benefit strengthened – In March 2026, results from the Phase 2b PARADIGM study were published in JAMA Neurology, providing peer-reviewed validation of PrimeC’s clinical and biological activity. Long-term follow-up reported in February 2026 showed a statistically significant 65% reduction in the risk of death and an estimated median survival of 36.3 months for participants treated continuously with PrimeC, compared with 21.4 months for participants initially assigned to placebo before crossing over to PrimeC.
  • Primary  endpoint achieved – In June 2026, NeuroSense announced that PARADIGM achieved its primary endpoint, demonstrating a statistically significant treatment-associated reduction in extracellular vesicle-associated TDP-43 compared with placebo. TDP-43 pathology is present in more than 97% of ALS cases, and the finding adds to the consistent body of evidence observed across clinical outcomes, survival and multiple disease-relevant biomarkers.
  • Canadian regulatory pathway advanced toward NDS filing – NeuroSense held a constructive Pre-NDS meeting with Health Canada and subsequently completed the Pre-NDS process. Final meeting minutes reflected alignment on the planned content and structure of the ALS submission, and the Company is now targeting an NDS filing in early December 2026, supported by the expanded PARADIGM clinical, survival and biomarker package.
  • Alzheimer’s program and global intellectual property portfolio advanced – The Phase 2 RoAD proof-of-concept study reported positive biomarker findings across multiple neurodegenerative disease pathways, providing early biological evidence consistent with potential target engagement. NeuroSense also strengthened its Alzheimer’s program through a U.S. patent covering use of PrimeC through 2043 and the addition of Prof. Steven E. Arnold to its Scientific Advisory Board. During 2026, the Company further expanded PrimeC composition patent protection through 2042 with grants in Australia, Brazil, Japan and South Korea.

H1 2026 Financial Results:

  • Research and development expenses for the six months ended June 30, 2026 and 2025 were $2,102 thousand and $2,503 thousand, respectively. The decrease of $401 thousand, or 16%, was mainly attributed to decrease in our subcontractors and consultants which was offset by an increase in share-based payment expense.
  • General and administrative expenses for the six months ended June 30, 2026 and 2025 were $1,345 thousand and $2,189 thousand, respectively. The decrease of $844 thousand, or 38.6%, was mainly attributed to decrease in professional services.
  • Operating expenses for the six months ended June 30, 2026 and 2025 were $3.4 million and $4.7 million, respectively due to the reasons described above.

A summary of NeuroSense’s unaudited consolidated financial results is included in the tables below.

NeuroSense Therapeutics Ltd.
Condensed Consolidated balance sheets
U.S. dollars in thousands
June 30,December 31,
20262025
Assets
Current assets:
Cash and cash equivalent231166
Other receivables540565
Restricted deposit7347
Total current assets844778
Non-current assets:
Property, plant and equipment, net5258
Operating right of use assets–170
Restricted deposit–22
Total non-current assets52250
Total assets8961,028
Liabilities and Equity
Current liabilities:
Trade payables729799
Other current liabilities (*)2,2701,717
Total current liabilities2,9992,516
Non-current liabilities:
Lease liability less current maturity–72
Total liabilities2,9992,588
Shareholders’ equity:
Authorized: 200,000,000 and 90,000,000 shares at June 30, 2026 and December 31,
2025;
Issued and outstanding: 1,836,154 and 1,627,859 shares at June 30, 2026 and
December 31, 2025, respectively (**)		––
Share premium and capital reserve49,24546,225
Accumulated deficit(51,348)(47,785)
Total Shareholders’ deficit(2,103)(1,560)
Total liabilities and shareholders’ deficit8961,028
(*) Including balance with related parties at the amount of $599 thousand and $602 thousand as of June 30, 2026
and December 31, 2025, respectively.
(**) After giving effect to the reverse share split, see also note 5.
NeuroSense Therapeutics Ltd.
Condensed Consolidated Statements of Comprehensive Loss
U.S. dollars in thousands except share and per share data
Six
months
ended
June 30,
2026		Six
months
ended
June 30,
2025
Research and development expenses(2,102)(2,503)
General and administrative expenses(1,345)(2,189)
Operating loss(3,447)(4,692)
Financing expenses, net(116)(17)
Net loss and comprehensive loss(3,563)(4,709)
Basic and diluted net loss per share (*)(2.1)(3.7)
Weighted average number of shares outstanding used in computing basic and
diluted net loss per share (*)		1,731,2551,270,132
(*) After giving effect to the reverse share splits, see also note 5.
NeuroSense Therapeutics Ltd.
Condensed Consolidated Statements of Changes in Shareholders’ deficit
U.S. dollars in thousands (except for share and per share data)
Ordinary sharesShare
premium
and
capital		AccumulatedTotal
Number
(*)		Amountreservedeficitequity
Balance as of January 1, 20261,627,859$–$46,225$(47,785)$(1,560)
Issuance of shares, net120,483–2,066–2,066
   Exercise of RSus and pre-funded warrants14,814–**)–**)
   Share-based compensation72,998–954–954
Net loss and comprehensive loss–––(3,563)(3,563)
Balance as of June 30, 20261,836,154$–$49,245$(51,348)$(2,103)
(*) After giving effect to the share splits and the reverse share splits, see also note 5.
(**) Less than $1 thousand.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within approximately 3 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

About PARADIGM

PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial of PrimeC in ALS. The trial included 68 participants living with ALS in Canada, Italy, and Israel. 

During the first 6 months of the trial, 45 participants were randomized to receive PrimeC, and 23 participants were randomized to receive placebo. This was followed by a 12-month open-label extension with all participants receiving PrimeC in a blinded manner, where neither the participants nor the clinical staff were aware of the initial treatment allocation. 

Most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug.   

About PrimeC

PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS. NeuroSense completed a Phase 2a clinical trial which met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC’s biological activity. PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency.

About NeuroSense

NeuroSense Therapeutics is a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease. The Company’s lead product candidate, PrimeC, is a novel oral therapy designed to target multiple key biological pathways underlying disease progression, including neuroinflammation, oxidative stress and dysregulated iron metabolism.

NeuroSense has recently completed analysis of long-term follow-up data from its Phase 2b PARADIGM study in ALS, with results published in JAMA Neurology showing slowing of functional decline relative to placebo. The Company also reported changes across multiple biomarkers associated with ALS, including microRNAs, consistent with PrimeC’s multi-target mechanism of action.

NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate its pivotal Phase 3 clinical trial (PARAGON) in ALS, to be conducted primarily in the United States. As described above, the Company is working with FDA on an optimized design for the study.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, among other things, statements regarding the Company’s planned Canadian New Drug Submission for PrimeC, the regulatory pathway and future development of PrimeC, including the Company’s planned U.S. development strategy, potential clinical trials and regulatory interactions, the potential benefits of PrimeC, the Company’s financing activities and capital resources, potential collaborations, partnerships and strategic transactions, and the Company’s future business, operational and strategic plans.

Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Actual results could differ materially from those anticipated or implied by such statements as a result of various risks and uncertainties, including, among others, risks relating to the Company’s ability to obtain additional financing; the timing, outcome and costs of regulatory submissions, interactions and approvals; the timing, design, initiation, conduct and results of clinical trials; the possibility that existing clinical, survival or biomarker data may not support future development or regulatory objectives; the Company’s ability to execute its development strategy; the availability of strategic, partnering or financing opportunities; the Company’s ability to maintain compliance with Nasdaq listing requirements; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (SEC).

You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2026 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

SOURCE NeuroSense

For further information: For further information: Email: [email protected], Tel: +972 (0)9 799 6183

Release – Nutriband Appoints Decorated Navy SEAL and Veterans Health Advocate Robert J. O’Neill to Advisory Board

Posted on by [email protected]
Nutriband-logo

Research News and Market Data on NTRB

GlobeNewswire

Friday, September 25, 2026, 8:00:00 AM EDT

ORLANDO, Fla., Sept. 25, 2026 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB) (NASDAQ:NTRBW) today announced the appointment of Robert J. O’Neill to its Advisory Board. O’Neill is a highly decorated former U.S. Navy SEAL, New York Times best-selling author, and nationally recognized speaker on leadership and resilience.

O’Neill served 16 years in the U.S. Navy, including eight years with the Naval Special Warfare Development Group (SEAL Team Six), and took part in more than 400 combat missions across four theaters of war. He is widely known for his role in Operation Neptune’s Spear, the 2011 mission that resulted in the death of Osama bin Laden. Over his career he was decorated more than 50 times, including two Silver Stars and four Bronze Stars with Valor. He is the author of the New York Times best-selling memoir The Operator: Firing the Shots That Killed Osama bin Laden and My Years as a SEAL Team Warrior, and is a regular contributor to national media on leadership, decision-making under pressure, and national security.

O’Neill remains closely connected to the military and veteran community, and has been a visible advocate for expanding access to emerging health treatments, including appearing alongside fellow veterans at this year’s White House executive order signing aimed at accelerating research and access to psychedelic-assisted therapies through the VA. His continued engagement with veteran service organizations and the broader military community reflects a career-long commitment to those he served alongside. His experience in fighting for adequate care pairs perfectly with Nutriband’s advancement of AVERSA as the company continues towards approval and commercialization of AVERSA Fentanyl which would be the worlds first and only abuse deterrent fentanyl patch if approved.

“Rob has spent his career operating at the highest levels of pressure, precision, and decision-making, and he’s continued that same commitment through his advocacy for adequate care and the military community he comes from,” said Gareth Sheridan, CEO of Nutriband Inc. “Those are exactly the qualities we look for as we scale Nutriband and AVERSA™ into new markets, and his perspective will be a real asset to our team as we continue to grow.”

Nutriband’sAdvisory Board supports the Company’s executive team on strategy, growth, and execution as it advances its pipeline of abuse-deterrent transdermal products, including AVERSA™ Fentanyl.

About Nutriband Inc.

We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse deterrent fentanyl patch incorporating our AVERSA™ abuse deterrence technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words “believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s periodic and current reports on Form 10-K, Forms 10-Q and 8-K and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Contact Information:
Nutriband Inc.
Phone: 407-377-6695
Email: [email protected]

Source: Nutriband Inc.

© 2026 GlobeNewswire, Inc.

Release – Ocugen Receives Provisional Approval and Priority Designation Under the Longevity and Regenerative Therapies Act in The Bahamas to Provide OCU400 to Patients for Treatment of Retinitis Pigmentosa

Posted on by [email protected]

Research News and Market Data on OCGN

September 25, 2026

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  • Ocugen will provide its investigational modifier gene therapy OCU400 through an expanded access program (EAP), with the goal of enabling the first patient to be treated for retinitis pigmentosa (RP) within 90 days, following full approval by the Longevity and Regenerative Therapies Board (LARTA Board)
  • In partnership with the LARTA Board, Ocugen intends to address global access and unmet need through commercial pricing evidenced with cost-effectiveness for a one-time broad treatment of RP
  • A novel modifier gene therapy for RP, OCU400 is advancing through Phase 3, with topline data expected in 1Q 2027 and a Biologics License Application submission planned for 2Q 2027

MALVERN, Pa., Sept. 25, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that OCU400 has been granted provisional approval and priority designation from the LARTA Board, the regulatory agency responsible for reviewing and approving longevity and regenerative therapy programs within the Commonwealth of The Bahamas. Ocugen will supply OCU400 through an EAP, with the goal of treating the first RP patient within 90 days, following full LARTA approval.

“Our partnership marks an important milestone for Ocugen – creating a unique opportunity to provide global access through the Bahamas to OCU400 for people suffering from retinitis pigmentosa,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen. “This landmark collaboration demonstrates the potential of our differentiated gene therapy platform and represents an exciting step toward expanding the reach of our innovative, one-time treatments for patients with serious retinal diseases.”

LARTA Priority Designation
LARTA Priority Designation recognizes the scientific and clinical promise of a program and its potential to address significant unmet medical need. When granted alongside Provisional LARTA Approval, it places the program on a structured pathway of enhanced regulatory engagement and expedited coordination, designed to advance it towards Full Approval, operational readiness and responsible patient access.

About OCU400
OCU400 is a modifier gene therapy candidate, currently in Phase 3, targeting a broad RP indication – from early-to late-stage disease; pediatric to adult patients – and is designed to treat mutations caused by more than 100 genes. It is based on a nuclear hormone receptor gene called NR2E3 which regulates diverse physiological functions within the retina, such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation, and cell survival. Retinal cells in RP patients have a dysfunctional gene network, and OCU400 is designed to reset this network to reestablish a healthy cellular homeostasis. OCU400 has been granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA), and Orphan Medicinal Product Designation (OMPD) by the European Medicines Agency (EMA).

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology company developing gene therapies for blindness diseases. The Company’s breakthrough modifier gene therapy platform has the potential to address significant unmet medical needs across large patient populations through a gene-agnostic approach. Unlike traditional gene therapies and gene-editing technologies that target a single gene mutation, Ocugen’s modifier gene therapies are designed to address the underlying disease biology by restoring balance across multiple gene networks. The Company is currently advancing programs for inherited retinal diseases and other causes of blindness that affect millions worldwide, including retinitis pigmentosa, Stargardt disease, and geographic atrophy, an advanced form of dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on LinkedIn and X.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, including the timing of enrollment and data readouts, the ability to initiate new clinical programs, statements regarding the ability to treat the first patient 90 days after obtaining Provisional LARTA Approval and Priority Designation in The Bahamas, qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, statements regarding potential market size and commercial possibilities of Ocugen’s product candidates, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that receipt of Provisional LARTA Approval and Priority Designation may not lead to faster regulatory review and Full Approval; that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing may not be predictive of the results or success of later clinical trials; and that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contacts:

Investors:
Candice Masse
astr partners
[email protected]

Media:
Chris Clark
[email protected]

NanoViricides (NNVC) – Phase 2 Clinical Trial For HV-387 In MPox Begins

Posted on by [email protected]


Thursday, September 24, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Phase 2 Trial Patient Enrollment Has Started. NanoViricides has begun enrolling patients in the Phase 2 clinical trial testing NV-387 for MPox Virus Infection in the Democratic Republic of Congo (DRC). This meets our expected timeframe for the start of the trial, with preliminary results expected in late 4Q26. We anticipate a second trial testing NV-387 to start shortly in the same region.

Phase 2 Trial Design. The trial is an open-label study designed to evaluate the efficacy and safety of NV-387 compared with the standard of care. The trial is being conducted in Lodja, Sankuru Province, DRC, a remote province not (yet) affected by the Ebola outbreaks seen in other regions. NV-387 is formulated as an oral solid (gummies) that does not require refrigeration or cold storage, making it practical to administer in remote regions.


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Release – Phase II Clinical Trial of NV-387 as a Treatment for Monkeypox (MPox) Has Begun in DRC, Announces NanoViricides

Posted on by [email protected]

Research News and Market Data on NNVC

Wednesday, 23 September 2026 08:30 AM

Topic: 

Company Update

SHELTON, CT / ACCESS Newswire / September 23, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”) today announced that the Phase II Clinical Trial of the Company’s Novel Broad-Spectrum Antiviral Drug NV-387 as a Treatment for Monkeypox Virus Infection has begun with enrollment of first patients in the Democratic Republic of Congo (DRC).

This clinical trial was registered in the Pan African Clinical Trials Registry database (pactr.samrc.ac.za). The unique identification number for this clinical trial is PACTR202609506749917.

The clinical trial is entitled: “An adaptive international, multi-center, randomized, open-label, interventional, parallel group, phase II (IIa and IIb) clinical trial to evaluate the efficacy and safety of a new chemical entity NV-387 formulated as oral gummies in comparison to standard of care, administered in patients with clinical signs of mpox disease and laboratory confirmed or presumptive hmpxv infection.”

The Principal Investigator for this clinical trial is Prof. Vivi Maketa Tevuzula, MD, MSc, PhD, Professor in the Department of Tropical Medicine at the University of Kinshasa and Principal Investigator at the Institut Multisectoriel pour l’Amélioration du Bien-être (IMABE), Kinshasa, DRC. Her work focuses on infectious diseases, including clinical trials demonstrating the safety and efficacy of novel drugs, and safety, immunogenicity, and efficacy of vaccines, as well as health systems research in resource-limited settings. She has served as principal investigator on multiple international studies on malaria, Mpox, and vaccine-preventable diseases, and leads interdisciplinary research on genomic surveillance and One Health approaches.

Bayer Foundation awarded Dr. Vivi Maketa with the prestigious Early Excellence in Science Award 2023 in Medical Science, recognizing her exceptional contributions to the design and implementation of research projects on infectious and neglected tropical diseases i.

“We are pleased to have Professor Maketa lead this clinical trial,” said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, “This is the very first Phase II clinical trial of the broad-spectrum antiviral drug NV-387 and aims to explore its safety and effectiveness in Mpox.”

There is no approved drug for Mpox. Clinical trials of a drug called tecovirimat (TPOXX, SIGA) have previously failed to demonstrate efficacy against both Mpox Clade II and Mpox Clade I. Tecovirimat was approved by US FDA for Smallpox under the Animal Rule provision.

A pan-African clinical trial called “MOSA” of a drug called brincidofovir, which is approved by US FDA for Smallpox under the Animal Rule provision, that started in January, 2025, is currently ongoing. As of January 2026, according to a press release, this study’s Data Safety and Monitoring Board (DSMB) did not identify any new safety concern after the first 50 patients were randomized, and the trial plans to enrol a further 50 patients in the first half of 2026, to perform interim efficacy analysis of brincidofovir ii. Brincidofovir requires constant physician care due to dose-limiting liver and gastro-intestinal toxicity concerns iii.

NV-387 could become the “go to” pandemic response drug if it is successful in this Phase II MPox clinical trial, and becomes a FDA-licensed (approved) drug. US Government SNS stockpiling contracts for existing smallpox drugs TPOXX and TEMBEXA have been in several hundreds of millions of dollars, representing an equivalent potential opportunity for NV-387.

The Phase II clinical trial for NV-387 as a treatment of mpox is being conducted at Lodja in Sankuru province in DRC. As of now, this province is not an ebola-affected region.

Professor Maketa’s team is already on site in DRC. In addition, The team of our CRO from India, Om Sai Clinical Research Pvt. Ltd., is also on site in DRC to start the clinical trial.

Lodja is a remote location and mpox cases are continuing to occur in that area. This is a resource-poor region. Setting up the clinical sites required several months of effort because of the resource limitations at the hospital.

MPox Clade I is endemic in DRC and all cases in the clinical trial are expected to be of the Clade I virus. The other prominent MPox virus, MPox Clade II is substantially less severe an infection than MPox Clade I.

MPox Clade II has become endemic in the USA, circulating at low levels. It primarily affects a limited population of Men-having-Sex-with-Men (MSM), because of transmission during sexual activity.

MPox is an “Orphan Disease” in the USA. NanoViricides has applied to the US FDA for Orphan Drug Designation (ODD) of NV-387 for the treatment of MPox. This ODD, assuming it is granted, would enable several benefits including frequent meetings with FDA, waiver of certain FDA fees, certain R&D credits, as well as extension in exclusivity in marketing once approved.

These ODD benefits can have a positive economic impact for NanoViricides estimated in the range of tens of millions of dollars.

MPox Clade I cases in the USA have been slowly increasing. As of August 27, 2026, since November 2024, there have been more than 50 confirmed cases of Mpox Clade I in the USA, all of which were either travelers to Mpox-manifesting countries or regions, or contacts of such travelers, according to the CDC iv. Community spread of the MPXV Clade I is likely occurring, with 3 cases of MPox Clade I with no travel to Africa, in California in unconnected persons, according to the CDC v. However, the potential for a widespread outbreak remains low.

From 2023-2025, about 1,700-2,800 cases of Mpox Clade II were confirmed in the USA, mostly occurring in men-having-sex-with men and associated sexual partners, according to the CDC (ibid #4). Clade II is transmitted via skin abrasions.

Thus MPox is becoming important in the USA from the perspective of pandemic preparedness and response. Although there is a vaccine originally developed for smallpox, namely, Jynneos, that is in use to prevent MPox (primarily in clade II contacts), its immune protection was found to wane rapidly in a clinical study vi. The effectiveness of this vaccine is limited, at 36% for one dose and 66% for 2 doses against the less pathogenic MPox Clade II vii.

The vaccine effectiveness is likely to be much less against the more severe MPox Clade I.

Vaccines do not protect in the first few weeks, limiting their usefulness during pandemic.

We believe that there will be a strong opportunity for NV-387 for pandemic preparedness and response for the threats of Mpox and Smallpox in the USA if this Phase II clinical trial of NV-387 for the treatment of Mpox is successful. The two drugs in the USA Strategic National Stockpile (SNS), TPOXX and TEMBEXA, would be unsuitable for pandemic response if MPox Clade I spreads. Although both of these drugs are approved for Smallpox, a bioterrorism agent, under the FDA animal rule, the clinical trial failure of tecovirimat against Mpox which is a much less severe and far less lethal disease compared to Smallpox raises questions about its possible utility in a Smallpox bioterrorism event. In addition, the known toxicity profile and warnings for brincidofovir make it unsuitable for wide-scale deployment in a large outbreak scenario.

“NV-387, our broad-spectrum antiviral drug is poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases,” said Anil R. Diwan, Ph.D., adding “NV-387 is designed to mimic human cells to trap and destroy the virus. This single drug can target over 90-95% of human pathogenic viruses due to this biomimicry, which is reminiscent of the antibiotic penicillin that targets a large number of human pathogenic bacteria.”

NV-387 was found to possess strong antiviral activity against an orthopoxvirus in an animal model that is considered an important model to establish potential effectiveness against MPox and Smallpox viruses, as all of these viruses belong to the same family of orthopoxviruses.

In fact, NV-387 effectiveness matched the effectiveness of the small chemical drug tecovirimat in two different models of infection, one was direct skin infection, and the other was a direct lung infection, by the virus.

Escape of virus from tecovirimat is known to occur by a single point mutation in a viral protein called VP-37.

Vaccines, antibodies, and small chemical drugs such as tecovirimat for MPox/Smallpox, or oseltamivir (Tamiflu®), baloxavir (Xofluza®) for Influenza are readily escaped by viruses simply by introduction of small changes that viruses undergo when they are faced with these challenges in the field.

In contrast, escape of virus from NV-387 is highly unlikely because no matter how much the virus changes in the field, it continues to use sulfated proteoglycans such as HSPG as “attachment receptor” in order to cause cell infection. NV-387 mimics the sulfated proteoglycan signature feature that the viruses require.

NV-387 is a host-mimetic drug that “looks like a cell” to the virus, displaying numerous ligands that mimic the sulfated proteoglycan, enticing the virus to bind to and become engulfed by the NV-387 dynamic shape-shifting polymeric micelle.

Therefore development of NV-387, a broad-spectrum host-mimetic, direct-acting antiviral drug that the viruses cannot escape even as they change constantly, will be revolutionary once the drug undergoes regulatory development for approval for use in humans.

New viruses and existing viruses acquiring greater pathology and infectivity are bound to keep appearing in time. To combat such threats, we need to develop broad-spectrum drug arsenal that the viruses cannot escape. Vaccines and antibodies simply will not do, and their limitations have become clearly evident during the COVID-19 pandemic.

About NanoViricides

NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.

Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.

The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides’ platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company’s pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.

This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

Where stated with an ® , the name is a registered trademark, which belongs to the owner of the trademark name.

FDA refers to US Food and Drug Administration. IND application refers to “Investigational New Drug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency’s (EMA) committee responsible for human medicines. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
[email protected]

Public Relations Contact:
[email protected]

i https://www.bayer-foundation.com/lets-spotlight-our-science-talents-dr-vivi-maketa

ii https://mpx-response.eu/a-first-safety-interim-analysis-of-mosa-shows-no-signal-of-safety-concerns-with-brincidofovir-a-potential-antiviral-to-fight-mpox/

iii According to the drug label (prescribing information), brincidofovir (“TEMBEXA”) carries a black box warning, and has warnings for elevations in hepatic transaminases and bilirubin (liver toxicity) and diarrhea and other gastrointestinal adverse events. Brincidofovir administration must be performed under physician care with continuous evaluation of liver toxicity.

iv https://www.cdc.gov/monkeypox/situation-summary/index.html

v https://www.aha.org/news/headline/2025-10-29-cdc-says-3-cases-severe-mpox-california-may-be-linked-august-case

vi https://www.cidrap.umn.edu/mpox/amid-new-mpox-outbreak-study-suggests-waning-protection-jynneos-vaccine

vii From the Mpox Emergency Response Team, CDC (2023-05) “Vaccine Effectiveness of JYNNEOS against Mpox Disease in the United States,” N Engl J Med 2023;388:2434-43.

SOURCE: NanoViricides

Release – MAIA Biotechnology Expands Pivotal Phase 3 THIO-104 Non-Small Cell Lung Cancer Trial into Spain and Portugal

Posted on by [email protected]
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Research News and Market Data on MAIA

September 23, 2026 9:17am EDT Download as PDF

THIO-104 advances toward key 2027 interim survival analysis

CHICAGO, Sept. 23, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing immunotherapies for cancer, today announced that it has received regulatory approval by the Spanish Agency for Medicines and Medical Devices (AEMPS) and Portugal’s National Authority of Medicines and Health Products (INFARMED) to begin screening patients for its ongoing pivotal Phase 3 THIO-104 clinical trial in non-small cell lung cancer (NSCLC).

Spain and Portugal represent important European markets for NSCLC, with an estimated 30,000 new cases annually across the two countries. Spain has a substantial lung cancer burden associated with historical tobacco exposure, with lung cancer incidence among women continuing to rise. In Portugal, NSCLC accounts for approximately 82% of lung cancer cases, the highest proportion reported among five European populations evaluated in a comparative study.

“Expanding THIO-104 into Spain and Portugal represents another important step in the execution of our pivotal Phase 3 program,” said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. “Clinical trial participation can provide patients with access to investigational therapies in markets where access to newly approved lung cancer treatments has historically lagged. By establishing THIO-104 sites in Spain and Portugal, we are broadening access to a potentially important new treatment option for patients with advanced NSCLC who have progressed following standard of care treatments.”

To date, THIO-104 has enrolled 65 NSCLC patients resistant to chemotherapy and checkpoint inhibitor treatments at 28 clinical sites in 6 European countries and 10 sites in Taiwan. Among the six European countries, sites in Hungary, Poland, and Turkey are actively enrolling and dosing patients from populations with the highest lung cancer incidence and mortality rates in Europe and globally.1

MAIA targets 100 patients dosed in THIO-104 by year-end 2026 and expects to have sufficient survival data to conduct an interim data analysis in 2027.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
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1 Sources: Global Cancer Observatory (GLOBOCAN), European Cancer Information System (ECIS), World Cancer Research Fund

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Source: MAIA Biotechnology, Inc.

Released September 23, 2026