Category: Healthcare

Release – NanoViricides’ Revolutionary Broad-spectrum Drug Candidate NV-387 Has Successfully Demonstrated Excellent Indications for Safety and Toxicology in a Juvenile Mouse Pups Animal Study, Paving the Way for Pediatric Use in Clinical Trials

Posted on by [email protected]

Tuesday, 20 October 2026 08:45 AM

SHELTON, CT / ACCESS Newswire / October 20, 2026 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) (the “Company”), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announces that its broad-spectrum antiviral drug NV-387 has successfully demonstrated strong safety, tolerability, and toxicological parameters in an animal model study involving juvenile mouse pups.

This study is expected to pave the way for pediatric use of NV-387 in clinical trials in children possibly as young as 1 year old.

Pediatric drugs for Ebola, Mpox, and Measles, as well as RSV – to name a few of the Company’s current or contemplated clinical trial programs – are unmet medical needs.

NV-387 is an extremely broad-spectrum antiviral drug that has demonstrated strong effectiveness in relevant animal models of multiple human viral infections. These include RSV, COVID, Influenza, Mpox, Smallpox, and Measles.

The Impact of the Juvenile Animal Model Study of NV-387 Treatment

NV-387 Oral Gummies formulation is currently in a Phase II clinical trial for the treatment of Ebola in the Democratic Republic of Congo (DRC). The novel Ebola Bundibugyo virus is known to disproportionately affect children i. NanoViricides anticipates being able to add a pediatric cohort in a Phase III registrational clinical trial, assuming the drug is found to be effective in the current Phase II clinical trial. If successful, NV-387 will likely be the first and only treatment for Ebola virus infection in children. There is no approved treatment nor an approved vaccine for the Ebola Bundibugyo virus.

NV-387 is also currently in another Phase II clinical trial for the treatment of Mpox in the Democratic Republic of Congo (DRC). Mpox Clade I, which is the currently most prevalent version of this virus, is known to disproportionately affect children. There is no approved treatment for Mpox. If Phase II is successful, we intend to add a pediatric cohort in the following Phase III registrational clinical trial.

NV-387 as a Treatment for Measles was granted an Orphan Drug Designation as well as a Rare Pediatric Disease Drug Designation by the US FDA. Measles primarily affects children. There is no approved treatment for Measles. The Company intends to perform a Phase II and, if successful, a Phase III clinical trial for NV-387 as a Treatment for Measles, towards a US FDA Marketing Authorization Application. If the program is successful and MAA is granted, then the Company will be eligible for a Priority Review Voucher (PRV). A PRV can fetch around $200 million if sold to another Pharma company ii, enabling substantial revenues even prior to achieving significant commercial sales.

The Juvenile Animal Model Study of NV-387 Oral Gummies Treatment and Results

Under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) was determined to be 1,230 mg/kg per dose administered three times daily, or 3,690 mg/kg/day, or a total cumulative drug exposure of 44,280 mg/kg over the 12 day dosing period. This was actually the highest dose level tested. Therefore, a Maximum Tolerable Dose (MTD) could not be estimated iii.

These numbers are indicative of extremely strong safety and will enable a wide range for dosing of NV-387 in pediatric clinical trials for the treatment of various viral diseases.

A 12 Day Repeated-Dose Safety/Tolerability, Toxicity and Toxicokinetic Study with a 14-Day Recovery Period in Juvenile Balb/c Mouse Pups, was conducted to evaluate the safety/tolerability, toxicity and toxicokinetic profile of NV-387 Oral Gummies, containing the active pharmaceutical ingredient (API) NV-387. The Juvenile Balb/c mouse pups received NV-387 Oral Gummies formulation doses three times daily for up to 12 consecutive days, followed by recovery period to assess persistence, reversibility, or delayed occurrence of any treatment-related effects.

NV-387 Oral Gummies were well tolerated at all dose levels, including the highest dose of 1,230 mg/kg per dose amounting to drug exposure of 3690 mg/kg/day, or a total cumulative drug exposure of 44,280 mg/kg over the 12 day dosing period. There was no mortality, systemic toxicity, treatment-related clinical observations, adverse effects on body weight gain, alterations in cardiovascular parameters, changes in clinical pathology, or treatment-related gross or microscopic pathological findings observed in either sex.

Most Recent Annual Report

The “Company” has previously reported 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). The Company’s Financial Statements included in its Annual Report on Form 10-K for the fiscal year ended June 30, 2026, contained an audit report from its Independent Registered Public Accounting Firm with an explanatory paragraph emphasizing that the audit opinion expressed substantial doubt about its ability to continue as a going concern. Release of this information is required by Section 610(b) of the NYSE American Company Guide and does not reflect any change or amendment to any of the Company’s filings for the fiscal year ended June 30, 2026.

Management’s Plan of Financing Activities, in Particular, Financing Clinical Trials

Management believes that the Company is working on diseases of global importance with a potential for a high positive impact. In particular, the Phase II Clinical Trial of NV-387 Oral Gummies for the Treatment of Ebola Virus Disease in DRC, is addressing a global high priority concern.

The USA has been, laudably, and proudly, the largest provider of humanitarian and relief assistance in this Ebola outbreak, with almost $1.4 Billion in contributions. The USA has already provided $887 Million, and has pledged another $500 Million, of which $267 million has been released, according to the US Department of State iv. This includes support for various public health measures, on site personnel, as well as funding for clinical trials of drugs and vaccines that were already under the auspices of US Government agencies. All of these supported drugs require infusions, a procedure that is not scalable for response in such a rapidly growing outbreak that the current Ebola Bundibugyo virus outbreak has turned out to be.

We believe that NV-387 being the only oral treatment in clinical trial for Ebola, there is a strong potential for non-dilutive funding for this regulatory development of NV-387 towards licensure. Management is continuing to work on obtaining non-dilutive funding for NV-387 as a unique and novel broad-spectrum antiviral, that we believe is revolutionary in the field of treatment of viral diseases, and now, in particular, for Ebola.

Additionally, we plan on continuing our efforts at financing the Company, when opportune, through different equity-based funding routes. In particular, the Company has an “At-the-Market” facility with an investment brokerage house, for issuing and selling common shares directly to investors.

Additional details can be found in the annual report filing.

Forward Looking Statements

Certain matters discussed in this press release are ‘forward-looking statements’ intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. In particular, the Company’s statements regarding trends in the marketplace, future revenues, earnings and Adjusted EBITDA, the ability to realize firm backlog and projected backlog, cost cutting measures, potential future results and acquisitions, are examples of such forward-looking statements. The forward-looking statements are subject to numerous risks and uncertainties, including, but not limited to, the timing of projects due to variability in size, scope and duration, the inherent discrepancy in actual results from estimates, projections and forecasts made by management, regulatory delays, changes in government funding and budgets, and other factors, including general economic conditions, not within the Company’s control. The factors discussed herein and expressed from time to time in the Company’s filings with the Securities and Exchange Commission could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

ABOUT NANOVIRICIDES

NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) 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.

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]

Source: NanoViricides, Inc.

Two Biotech IPOs Raise $350 Million as Investor Appetite for New Drug Developers Rebounds

Posted on by [email protected]

City Therapeutics and Iambic Therapeutics make strong Nasdaq debuts, highlighting renewed interest in RNA-based medicines and AI-powered drug discovery.

The biotechnology IPO market showed fresh signs of momentum last week as City Therapeutics (NASDAQ: CTY) and Iambic Therapeutics (NASDAQ: IAM) raised a combined $350 million in public offerings. Both companies attracted strong investor interest and delivered positive first-day trading performances, suggesting that demand for emerging drug developers may be improving despite broader market volatility.

City Therapeutics, a Cambridge, Massachusetts-based biotechnology company developing RNA interference (RNAi) medicines, raised approximately $200 million through an upsized initial public offering. The company sold 11.1 million shares at $18 each, exceeding its original fundraising target, and began trading on the Nasdaq on October 16.

Shares climbed approximately 24% during their first trading session, closing at $22.40 and giving the company a strong public-market debut.

Founded in 2023, City Therapeutics focuses on RNAi technology, which works by silencing specific genes responsible for producing disease-related proteins. Its lead candidate, CITY-FXI, is undergoing Phase 1 clinical testing for thromboembolic diseases, conditions involving potentially dangerous blood clots.

The company’s broader pipeline includes CITY-RBP4, targeting Stargardt disease and other retinal disorders, and CITY-TFR2, being developed for anemia associated with chronic diseases. The IPO proceeds will help advance these programs through clinical development.

Meanwhile, San Diego-based Iambic Therapeutics raised $150 million through the sale of approximately 9.4 million shares priced at $16 each. The company began trading on October 15 under the ticker IAM, with shares gaining approximately 13% during their first session.

Iambic represents a different segment of biotechnology innovation, combining artificial intelligence with automated laboratory experimentation to accelerate drug discovery.

Its proprietary technology uses AI models to analyze molecular structures, predict drug behavior, and identify promising therapeutic candidates. The company believes this approach can reduce the time and resources traditionally required to discover and develop new medicines.

Iambic’s lead clinical candidate, IAM1363, is an experimental cancer treatment discovered using its AI-powered platform. The company also maintains a pipeline of additional oncology programs and partnerships with established pharmaceutical companies.

Investor interest in Iambic was supported by prominent institutional backers, including ARK Investment Management and Duquesne Family Office, which indicated interest in purchasing up to $60 million of shares in the offering. Nvidia has also established an investment and technology relationship with the company.

The successful debuts arrive during a period when biotechnology companies have faced challenging financing conditions, with higher capital costs and investor caution limiting access to public markets.

However, these offerings suggest investors remain willing to support companies with differentiated technologies, promising drug pipelines, and credible development strategies.

The contrasting approaches of City Therapeutics and Iambic also highlight two important investment themes. RNA-based therapies are expanding the range of diseases that can potentially be treated through targeted genetic mechanisms, while artificial intelligence is creating new opportunities to improve drug discovery efficiency.

Still, both companies remain clinical-stage developers, meaning their long-term success depends on achieving favorable clinical trial results, securing regulatory approvals, and eventually commercializing their treatments.

For investors, the combined $350 million raised and positive trading debuts provide encouraging evidence that the biotechnology IPO market may be regaining momentum. Whether that momentum continues will depend on broader market conditions, future clinical milestones, and the performance of newly listed companies.

The strong reception for City Therapeutics and Iambic suggests that innovative biotechnology remains an attractive investment opportunity, particularly where emerging technologies offer the potential to address significant unmet medical needs.

The contrasting approaches of City Therapeutics and Iambic highlight growing investor interest in innovative drug development platforms. That interest extends to smaller publicly traded biotechnology companies advancing novel treatments, including Ocugen (NASDAQ: OCGN), which is developing gene therapies for inherited retinal diseases, and MAIA Biotechnology (NYSE American: MAIA), which is advancing its investigational telomere-targeting cancer treatment, ateganosine. While these companies pursue different scientific approaches, they reflect the broader investment focus on targeted therapies addressing unmet medical needs. Meanwhile, Merck KGaA’s $1.3 billion acquisition of Silence Therapeutics further underscores the strategic value pharmaceutical companies are placing on emerging RNA-based medicines.

Release – NeuroSense Files U.S. Patent Application for Traumatic Brain Injury

Posted on by [email protected]

CAMBRIDGE, Mass., Oct. 19, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense” or the “Company”), a late-stage clinical biotechnology company developing treatments for neurodegenerative diseases, today announced that it has filed a patent application with the U.S. Patent and Trademark Office covering methods of treating traumatic brain injury (TBI) and related central nervous system injuries with the combination of ciprofloxacin and celecoxib, the active ingredients of PrimeC.

The application covers the treatment of a broad range of brain injuries, from concussion and mild TBI to moderate and severe TBI, including blast-related injury, as well as their long-term consequences, such as chronic traumatic encephalopathy (CTE). If granted, the patent is expected to provide protection through 2047, subject to any extensions.

Traumatic brain injury (TBI) represents a major global healthcare challenge, affecting millions of people each year. TBI can result from falls, motor vehicle accidents, sports-related injuries and military-related trauma, including blast exposure. Its consequences can extend well beyond the initial event, potentially causing persistent cognitive, physical and behavioral impairment, with substantial burdens on patients, caregivers and healthcare systems. Despite this significant unmet medical need, there are currently no approved disease-modifying therapies specifically targeting the secondary neurological injury associated with TBI.

Following the initial trauma, TBI can trigger complex biological processes, including neuroinflammation, oxidative stress and progressive neuronal damage. Certain mechanisms overlap with pathways implicated in neurodegenerative disorders.

The patent filing also supports NeuroSense’s longer-term strategy of pursuing additional applications for PrimeC beyond its existing development programs. The Company views TBI as an opportunity to broaden PrimeC’s commercial potential and build additional long-term value around its lead asset. While ALS remains NeuroSense’s primary development priority, the Company is evaluating future TBI-focused research and development initiatives, through strategic collaborations, research grants and other non-dilutive funding opportunities.

“While ALS remains our primary focus, we believe PrimeC may have potential across a broader range of neurological conditions that share common underlying disease mechanisms,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “TBI is a particularly compelling area given the large affected population, the long-term consequences of brain injury and the lack of approved disease-modifying treatments. This filing strengthens our intellectual property position and creates a foundation for future research, partnerships and non-dilutive funding opportunities, while maintaining our focus on advancing our core ALS program. We look forward to sharing further updates as our clinical and strategic initiatives advance.”

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 slower functional decline in participants who received PrimeC from study start than in those who initially received 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. 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.

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 target several key mechanisms that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation, with the potential to inhibit disease progression.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes progressive paralysis and, typically, death within 3 years of symptoms onset. 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.

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 are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the Company’s development program, including for ALS and TBI, the potential issuance, scope and duration of patent protection arising from the Company’s patent application, including expected protection through 2047, subject to any extensions, the potential of PrimeC to treat TBI and related central nervous system injuries, the potential expansion of PrimeC beyond ALS and its potential commercial benefits and long-term value. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. These risks include the risk that the patent application will not result in an issued patent or that any patent granted will not provide the Company with the anticipated scope or duration of protection or will be challenged, invalidated or unenforceable; the risk that PrimeC will not demonstrate safety or efficacy in TBI or related conditions; the potential for delay in the timing of the Phase 3 clinical trial (PARAGON) in ALS; the risk that the Company will not be able to obtain financing on acceptable terms, or at all; the risk that the Company will not regain and maintain compliance with the Nasdaq listing requirements; the risk that non-dilutive grant funding for the PARAGON trial will not be awarded or will be delayed; uncertainty regarding outcomes and the timing of current and future clinical trials; the risk that PrimeC will not advance towards later-stage development; timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; and other risks and uncertainties set forth in NeuroSense’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

Merck to Acquire Silence Therapeutics for $1.3 Billion in Major Gene-Silencing Biotech Deal

Posted on by [email protected]

The $20-per-share acquisition represents a 130% premium as Merck expands its rare disease pipeline and strengthens its position in RNA-based medicines.

German pharmaceutical and technology company Merck KGaA has agreed to acquire Silence Therapeutics (NASDAQ: SLN) in an approximately $1.3 billion all-cash transaction, highlighting growing interest in gene-silencing therapies and rare disease treatments. The deal, announced Monday, October 19, offers Silence shareholders $20 per American Depositary Share (ADS), representing a substantial 130% premium to the company’s closing price of $8.68 on Friday.

The acquisition values Silence Therapeutics at approximately $1.3 billion in equity and $1.1 billion in enterprise value. The purchase price also represents an 82% premium to the company’s 30-day volume-weighted average share price, underscoring the strategic value Merck places on its emerging drug pipeline.

At the center of the transaction is divesiran, an experimental RNA-based treatment targeting polycythemia vera, a rare form of blood cancer characterized by the excessive production of red blood cells. The condition can increase the risk of blood clots, strokes, and other serious cardiovascular complications, often requiring patients to undergo regular blood removal procedures to control their red blood cell levels.

Divesiran uses small interfering RNA (siRNA) technology to selectively silence a gene involved in regulating iron metabolism. By limiting iron availability for red blood cell production, the therapy aims to reduce the need for frequent blood removal treatments while improving disease management.

Recent Phase 2 clinical trial results have strengthened the drug’s potential. In the SANRECO study, divesiran achieved an 88% response rate compared with 19% for patients receiving placebo. Patients receiving the experimental therapy also required significantly fewer blood removal procedures, providing encouraging evidence ahead of planned Phase 3 development.

One potential advantage of divesiran is its dosing schedule. The treatment is designed to be administered through an injection once every three months, potentially offering patients a more convenient alternative to therapies requiring more frequent administration.

For Merck, the acquisition represents another step in its strategy to expand into specialized treatments addressing significant unmet medical needs. The company previously acquired SpringWorks Therapeutics in 2025, strengthening its presence in rare diseases and oncology. Adding Silence Therapeutics provides access to a promising late-stage drug candidate and a broader platform for developing RNA-based medicines.

The transaction also highlights the growing importance of gene-silencing technology within the biotechnology industry. Unlike traditional medicines that target proteins after they are produced, siRNA therapies work by reducing the production of specific disease-related proteins, potentially offering more targeted treatment approaches.

For biotechnology investors, the 130% acquisition premium demonstrates how promising clinical data can significantly increase the strategic value of smaller drug developers. Large pharmaceutical companies continue seeking innovative assets to replenish their pipelines, diversify revenue streams, and establish positions in emerging treatment categories.

However, divesiran remains investigational and must successfully complete additional clinical testing before potentially receiving regulatory approval. Its commercial prospects will depend on demonstrating sustained effectiveness, safety, and competitive advantages over existing treatments.

The transaction has received unanimous approval from Silence Therapeutics’ board and is expected to close during the first quarter of 2027, subject to shareholder, regulatory, and court approvals.

The acquisition reinforces a broader trend in biotechnology: pharmaceutical companies are increasingly willing to pay substantial premiums for innovative therapies supported by promising clinical results. As RNA-based medicine continues advancing, smaller biotechnology companies developing differentiated treatments could attract further acquisition interest from larger industry players.

Release – Tonix Pharmaceuticals Announces Presentations at World Vaccine Congress Europe 2026

Posted on by [email protected]

October 15, 2026 7:00am EDT

BERKELEY HEIGHTS, N.J., Oct. 15, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or “the Company”), a fully integrated, commercial-stage biopharmaceutical company, today announced an oral presentation on TNX-801, a live, attenuated, minimally replicative investigational vaccine platform based on horsepox virus to protect against mpox and other infectious diseases, and a working group session led by Tonix, “Vectored Vaccine Platforms: From Design to Improving Efficacy,” at the World Vaccine Congress Europe held in Amsterdam, Netherlands on October 19-21, 2026.

TNX-801 Presentation Details
Title: TNX-801 Vaccine Platform Safety and Efficacy
Date & Time: Oct. 21, 2026, 1:15 p.m. CEST
Session Category: Emerging & Infectious Diseases
Presenter: Farooq Nasar, Ph.D., MPH, Director, Virology, Research and Development Center (RDC), Tonix Pharmaceuticals

Other Session Details
Title: Working Group: Vectored Vaccine Platforms: From Design to Improving Efficacy
Date & Time: Oct 20, 2026, 11:30 a.m. CEST
Session Category: Working Groups
Presenters: Sina Bavari, Ph.D., Executive Vice President, Infectious Disease, RDC, Tonix Pharmaceuticals; Gabriella Worwa, DVM, Ph.D., Study Director, RDC, Tonix Pharmaceuticals; Matilu Mwau, Senior Principal Clinical Research Scientist, Professor of Infectious Diseases, Kenya Medical Research Institute (KEMRI)

About TNX-801
TNX-801 (recombinant horsepox virus) is an attenuated, minimally replicative, live virus vaccine platform based on horsepox in pre-clinical development to prevent mpox, smallpox, and other emerging infectious diseases. TNX-801 is expected to enter a Phase 1 study in 2027 pending FDA clearance of an Investigational New Drug Application (IND). TNX-801 is in the pre-IND stages of development.

Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals* is a fully integrated, commercial-stage biopharmaceutical company focused on central nervous system (CNS) disorders, infectious diseases, and immunology conditions with high unmet medical needs. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is extending the science behind TONMYA in Phase 2 clinical studies to evaluate the potential of TNX-102 SL in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including Phase 2-ready monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S., and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Within immunology, TNX-1500 (anti-CD40L mAb) is a Phase 2-ready, third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com.

*Tonix’s product development candidates, including TNX-102 SL for new, unapproved indications, are investigational new drugs or biologics. Their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.

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 by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are a number of 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, risks related to the failure to successfully launch and commercialize TONMYA® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts
Deborah Elson
Tonix Pharmaceuticals
[email protected] 
[email protected] 

NanoViricides (NNVC) – Ebola Trial Reports Ongoing Enrollment Progress

Posted on by [email protected]

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.

Patient Enrollment and Treatment Continue. Nanoviricides provided an update on the progress of its Phase 2a trial in Ebola, including additional details on its design, endpoints, and objectives. The Phase 2a trial began treating patients with NV-387 in the Democratic Republic of Congo (DRC) in late September. The company reported that enrollment is continuing, with data expected in 1Q27. 

Stages Of Infection Are Emerging. The current outbreak of Ebola virus disease (EVD) in the DRC has been caused by a new variant of the Bundibugyo Ebolavirus (BDBV). The development of symptoms varies between patients, and its diagnosis is still being refined. During the first 5 to 7 days after initial infection, mild symptoms may not even be noticeable. Patients typically seek treatment after about 5 to 7 days, when they begin vomiting and have severe diarrhea. The trial is expected to enroll most patients at this stage.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Ocugen (OCGN) – Ocugen Completes Licensing Agreement For MENA Region

Posted on by [email protected]


Thursday, October 15, 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.

Licensing Agreement Finalizes Terms Announced In July. Ocugen and Roots Pharmaceuticals have finalized a licensing agreement for the commercialization of OCU400 in the Middle East and North Africa. The license finalizes the terms that the two companies announced in July 2026. This advances Ocugen’s plan to market OCU400 worldwide.

Collaboration Covers A Large Territory. The agreement gives Kuwait-based Roots Pharmaceuticals and its strategic partner, Al-Dhow International Holding, exclusive rights for the Middle East and North Africa coastal countries (MENA region). Retinitis pigmentosa (RP) is estimated to have a higher incidence in this region than in the US and Europe, although we cannot project sales at this time.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – Ocugen and Roots Pharmaceutical Complete License Agreement for OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in the Middle East and North Africa

Posted on by [email protected]

October 14, 2026

MALVERN, Pa., Oct. 14, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the execution of a licensing agreement with Roots Pharmaceutical, and its strategic partner Al-Dhow International Holding, for the exclusive rights to OCU400, Ocugen’s novel modifier gene therapy for the treatment of Retinitis Pigmentosa (RP), in the Middle East and North Africa (MENA) region.

Subject to the terms of the License Agreement, Ocugen will receive an upfront license fee and potential initial development milestone payments of up to $4 million, in the aggregate, as well as potential sales milestone payments of up to $255 million, and royalties equaling 22% of OCU400 net sales generated by Roots Pharmaceutical. Ocugen will manufacture the commercial supply of OCU400 under terms of a related supply agreement.

Ocugen believes RP is a leading cause of inherited vision loss globally, with a particularly significant unmet need across the MENA region, where the prevalence of RP is estimated to be 10 to 20 times higher than in the U.S. and EU. Through OCU400, Roots Pharmaceutical aims to help address this substantial unmet need by potentially providing a treatment option for people in the MENA region living with RP and facing progressive vision loss and potential blindness.

“By partnering with Roots Pharmaceutical, an established leader with strong reach across the Middle East and North Africa, we are expanding our ability to bring our potential one-time gene therapy to patients in a region where retinitis pigmentosa is highly prevalent and the unmet medical need is significant,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer and Co-founder of Ocugen. “This agreement represents another important step in our strategy to build strong regional partnerships and expand global access to our potentially transformational gene therapies.”

Roots Pharmaceutical is an established and rapidly growing pharmaceutical company serving key markets across the MENA region. With more than two decades of operating experience and expertise in commercializing innovative medicines, the company’s regional capabilities and established healthcare relationships position it as a strong partner for bringing OCU400 to RP patients across MENA.

“This partnership reflects Roots’ commitment to bringing breakthrough gene therapies to the Middle East and North Africa, leading and shaping the treatment paradigm for our patients, which is our main objective,” said Dr. Islam Zayed, Chief Executive Officer and Co-Founder of Roots Pharmaceutical. “OCU400 has the potential to change the outlook, and the lives, of patients living with retinitis pigmentosa. We look forward to working closely with Ocugen to build the diagnosis-to-treatment pathway that gene therapy requires across our markets, and to exploring further collaboration across Ocugen’s ophthalmology pipeline.”

Ocugen continues to advance OCU400 through its Phase 3 liMeliGhT clinical trial with a topline data readout expected in the first quarter of 2027, followed by global regulatory submissions, including a Biologics License Application in the U.S. and a Marketing Authorization Application in Europe.

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 the Company on LinkedIn and X.

About Roots Pharmaceutical Company
Founded in Kuwait in 2006, Roots Pharmaceutical is a fully integrated healthcare provider specializing in commercializing innovative therapies, medical devices, and an aesthetic line across the Middle East and North Africa. It is led by a team with over 25 years of pharmaceutical industry experience.

Roots Pharmaceuticals has established a direct commercial presence in the MENA region (Middle East and North Africa), mainly in GCC countries and key North African countries, with a therapeutic portfolio spanning neurology, hematology, oncology, rare diseases, dermatology, cardiovascular, medical devices and aesthetic line.

With 30+ global partners and a $300M+ product pipeline, Roots Pharmaceutical and its strategic partner Al-Dhow Group are committed to delivering meaningful healthcare impact across the MENA region through innovation, access and excellence. Its operations are ISO 9001:2015-certified and externally audited by PwC.

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 the anticipated benefits to Ocugen of the definitive license agreement and supply agreement with Roots Pharmaceutical Company, as well as statements regarding strategy, the potential amounts of milestone payments and royalty payments that may be received under the license agreement, 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 data readouts and marketing applications, the ability to initiate new clinical programs, statements regarding 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. Ocugen 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 Ocugen’s current expectations, including, but not limited to, the risks that the license agreement and supply agreement with Roots Pharmaceutical Company will not lead to the current anticipated benefits to Ocugen; 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 Ocugen’s 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 Ocugen files with the SEC. Any forward-looking statements that Ocugen makes in this press release speak only as of the date of this press release. Except as required by law, Ocugen assumes 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, Ocugen
[email protected]

Big Pharma’s Patent Cliff Could Spark a New Wave of Small-Cap Biotech Acquisitions

Posted on by [email protected]

Major pharmaceutical companies are approaching a significant patent cliff that could accelerate mergers and acquisitions across the biotechnology sector. With an estimated $300 billion to $400 billion in pharmaceutical revenue facing patent-related pressure beginning in 2028, large drugmakers are looking for ways to replenish their pipelines and offset potential losses from expiring blockbuster drug patents.

For small-cap biotechnology companies, this shift could create new opportunities through acquisitions, licensing agreements, and strategic partnerships. Companies developing innovative treatments in oncology, gene therapy, and immunology may benefit from increased industry interest as major pharmaceutical manufacturers search for their next generation of revenue-producing therapies.

What Is the Big Pharma Patent Cliff?

The pharmaceutical patent cliff refers to the expiration of patent protection or market exclusivity on major branded medications. Once these protections expire, generic drugs and biosimilars can enter the market, potentially reducing sales of previously protected products.

For pharmaceutical companies that rely heavily on blockbuster medications, the resulting revenue pressure can be substantial. Replacing that revenue often requires years of research, clinical development, and regulatory approvals.

As a result, major drugmakers may increasingly look beyond their internal research programs to acquire or partner with smaller biotechnology companies developing promising treatments.

Why Patent Expirations Could Drive Biotech Mergers and Acquisitions

Acquiring smaller biotechnology companies can provide large pharmaceutical manufacturers with access to innovative drug candidates, specialized technologies, and established clinical development programs.

Rather than developing every new treatment internally, pharmaceutical companies can pursue acquisitions, licensing agreements, or strategic partnerships to expand their pipelines.

Oncology, immunology, rare diseases, and other specialized therapeutic areas remain important areas of strategic interest.

For small-cap biotech companies, these relationships can provide access to capital and development resources. However, the potential for acquisition interest depends on factors such as clinical results, intellectual property protection, regulatory progress, and the strategic priorities of prospective partners.

Small-Cap Biotech Companies Advancing New Treatments

Several emerging biotechnology companies are developing treatments in therapeutic areas relevant to the pharmaceutical industry’s long-term growth strategies.

Cardiff Oncology (CRDF): Advancing Onvansertib for Colorectal Cancer

Cardiff Oncology (NASDAQ: CRDF) is developing onvansertib, a PLK1 inhibitor being studied in combination with standard therapies for metastatic colorectal cancer.

The company has reported encouraging Phase 2 clinical results and outlined plans for a registrational trial, subject to additional financing.

Cardiff Oncology’s development program illustrates the type of clinical-stage innovation occurring within the small-cap biotechnology sector, particularly in oncology, where companies continue to investigate new approaches to treating difficult cancers.

Ocugen (OCGN): Gene Therapy and Strategic Licensing Opportunities

Ocugen (NASDAQ: OCGN) is developing gene therapies targeting inherited retinal diseases.

The company has pursued regional licensing opportunities as part of its broader development strategy, demonstrating how smaller biotechnology firms can seek additional resources while retaining certain commercial rights.

Licensing agreements can provide an alternative to outright acquisitions, allowing pharmaceutical partners to access emerging technologies without assuming the full cost of developing or purchasing a company.

Eledon Pharmaceuticals (ELDN): Immunology and Kidney Transplant Research

Eledon Pharmaceuticals (NASDAQ: ELDN) is advancing treatments involving immune modulation, including tegoprubart, an investigational therapy being studied in kidney transplantation.

Its development program reflects ongoing innovation in immunology and transplantation, therapeutic areas where unmet medical needs continue to drive research.

Cardiff Oncology, Ocugen, and Eledon represent different approaches to drug development. Their inclusion illustrates the diversity of clinical-stage innovation within the small-cap biotechnology sector and does not imply that acquisition discussions involving these companies are underway.

What Should Small-Cap Biotech Investors Watch?

Although the pharmaceutical patent cliff may encourage additional dealmaking, acquisition potential alone should not determine how investors evaluate biotechnology companies.

Clinical progress remains a critical consideration, particularly for companies that have not yet generated meaningful commercial revenue.

Investors following the sector should pay attention to several developments:

  • Clinical trial results: Positive data can strengthen a company’s development outlook, while disappointing results can create significant setbacks.
  • Regulatory milestones: Progress toward pivotal trials and potential approvals can influence a company’s prospects.
  • Cash reserves and financing: Many clinical-stage biotechnology companies depend on external capital to fund research and development.
  • Intellectual property: Patent protection and other exclusivity rights can influence the commercial value of emerging therapies.
  • Licensing and partnership announcements: Strategic agreements may provide financing, development support, or commercial opportunities.

Investors should also distinguish between acquisitions and licensing arrangements. Pharmaceutical companies may choose partnerships that provide access to promising treatments without taking on the full financial and operational responsibilities of an acquisition.

Could the Patent Cliff Accelerate Biotech M&A Activity?

Following a slowdown in biotechnology dealmaking over the summer, industry observers anticipate renewed acquisition interest as pharmaceutical companies prepare for upcoming patent expirations.

For the small-cap biotechnology sector, increased dealmaking could have implications beyond individual takeover transactions.

Strategic acquisitions and partnerships may establish valuation benchmarks for emerging therapeutic platforms, create financing opportunities, and influence investor sentiment across the industry.

However, these potential benefits remain dependent on clinical success, market conditions, and the willingness of larger pharmaceutical companies to pursue transactions.

As major drugmakers prepare for substantial patent-related revenue pressure, smaller biotechnology companies developing innovative treatments could play an increasingly important role in the industry’s long-term growth strategy.

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

Posted on by [email protected]

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

Posted on by [email protected]


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

Posted on by [email protected]

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

Posted on by [email protected]
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]