Category: Health

Release – As Ebola Spreads in Two More Provinces, NanoViricides Has Received National Ethics Committee Approval for a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for Ebola in Congo

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As Ebola Spreads in Two More Provinces, NanoViricides Has Received National Ethics Committee Approval for a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for Ebola in Congo

Research News and Market Data on NNVC

Monday, 13 July 2026 09:27 AM

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Company Update

SHELTON, CT / ACCESS Newswire / July 13, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), a clinical stage leader developing antiviral drugs that viruses cannot escape, announces that it has received National Ethics Committee approval for a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for the Current Bundibugyo Ebolavirus in the Democratic Republic of Congo (DRC). The Company is now getting ready to file a Clinical Trial Application to ACOREP, the regulatory agency in DRC.

NanoViricides has already put together a team with a renowned Principal Investigator and with support from a well known University in the Ebola-affected region for the execution of this clinical trial after regulatory approvals.

NV-387 Oral Gummies Drug Product has already been shipped to DRC, because of the ensuing Phase II clinical trial of NV-387 for the Treatment of Mpox. Sufficient quantity of NV-387 drug product is thus available in DRC for starting the clinical trial against Ebola as well.

The Ebola outbreak in the DRC continues to increase in spread. It has spread to two more northeastern provinces, Haut-Uele and Tshopo, and number of confirmed Ebola cases across the country rose to 1,926, including 702 deaths, official data showed late on Sunday, the country’s public health institute said in its latest report [1].

There is no approved Treatment or Vaccine for the new variant of the Bundibugyo Ebolavirus (BDBV) that is causing the current rapidly expanding outbreak of the Ebolavirus Disease (EVD) in DR Congo and Uganda. The rare Bundibugyo strain of Ebola virus causing the current outbreak appears to be its new variant, likely freshly introduced from some animal source[2], such as fruit bats.

NV-387 is the only orally active agent under consideration for clinical trial as a treatment of Ebola to the best of our knowledge. In an epidemic scenario in resource limited settings such as in DRC, oral drug is a highly advantageous feature.

“We believe NV-387 could be revolutionary in this fight against Ebola, if it is found to be effective,” said Anil R. Diwan, PhD, adding, “It is an oral drug, in contrast to other infusions. Thus evaluating if NV-387 treatment works is of paramount importance to combat this and future Ebola and Marburg outbreaks.”

Other treatments require infusions. Infusions are difficult to implement and also are not scalable in a large outbreak scenario if this Ebola virus outbreak continues to grow, as has been widely expected.

A clinical trial of an antibody cocktail MBP134, alongside MBP134 plus Remdesivir, has started as per WHO with first patient having received infusion of the antibody cocktail on July 2, 2026 [3]. Monoclonal antibodies are highly specific to the strain of virus and usually are not effective against unrelated strains.

Further, viruses readily escape antibodies after exposure to them.

In contrast, NV-387 is a broad-spectrum antiviral that mimics the host-side features that the virus requires, and is likely to be effective against Ebola viruses because they use the same feature mimicked by NV-387. It is highly unlikely that viruses can escape NV-387, because this drug mimics the features on host cells that the viruses continue to require even as they mutate or evolve in the field.

Additionally, NV-387 Oral Gummies is a drug product readily delivered orally. It does not even require swallowing effort or water, because it dissolves in the mouth by itself, simplifying delivery for even sick individuals with swallowing difficulties.

This oral delivery is an important feature that puts NV-387, a broad-spectrum antiviral, as being superior to the other approaches.

NanoViricides has retained Om Sai Clinical Research Private Limited, India, as the CRO for the Phase II Mpox clinical trial in DRC previously. Om Sai CRO has been instrumental in putting together a team of renowned experts to lead and execute the clinical trial of NV-387 as a treatment for Ebolaviruses in DRC.

The next steps for NanoViricides will be to perform appropriate submissions to the National Ethics Committee of DRC, and upon their approval, to submit a clinical trial application to the regulatory agency, ACOREP for approval to begin the clinical trial. Most of these documents are ready because the same drug NV-387 Oral Gummies has been approved by ACOREP for a Phase II clinical trial as a Treatment for Mpox in DRC.

NV-387 Oral Gummies drug product was recently shipped to DRC for the impending Phase II clinical trial of NV-387 as a Treatment for Mpox. It will thus be immediately locally available to combat the Ebola outbreak if it shows effectiveness against Ebola Bundibugyo in patients.

While there is currently minimal risk of Ebola in the USA, the CDC’s mathematical models suggested this Central African outbreak could grow to 10,000 to 20,000 cases and 2,000 to 4,000 deaths in the next three months alone, rivaling the largest outbreak to date in 2014-2016[4].

The outbreak which was declared a Public Health Emergency of International Concern (“PHEIC”) by the WHO on May 17, 2026, continues to rapidly expand, outpacing containment efforts. The outbreak arose in a high traffic region bordering the Democratic Republic of Congo (DRC), with travel contacts to Uganda, and South Sudan and with 11 more nations in Africa at risk[5].

Infusions with a new antibody cocktail, MBP134 (ZMapp), or a monoclonal antibody, Maftivimab (Regeneron), or a nucleotide analog Remdesivir are being considered for treatment and are likely to advance into clinical trials.

NV-387 was previously found to be superior to remdesivir in a lethal animal model of a viral disease. The Company believes this superiority of NV-387 is very likely to extend to the current novel Bundibugyo ebolavirus strain.

NV-387 is a broad-spectrum antiviral that mimics the host-side feature called heparan sulfate proteoglycan that over 90-95% of human pathogenic viruses require for infecting cells. No matter how much the virus changes in the field, it continues to use HSPG, and therefore it cannot escape the drug NV-387. In contrast, Remdesivir is a small molecule inhibitor of the viral RDRP enzyme needed for making copies of the viral genome, and the virus can possibly escape by small number of mutations.

All Ebola viruses utilize HSPG as the attachment receptor, followed by entry into the cell inside endosomes. The virus substantially dismantles in the endosome and hitches a cognate receptor called NPC1 to enter the cytoplasm where the next steps in its replication begin.

Thus there is a strong rationale that NV-387 could be highly effective against Ebola virus infections, not just Bundibugyo, but also the Sudan and other viruses for which there are no treatments.

NV-387 is available as an oral medication that has excellent stability at room temperature, enabling ease of transport, distribution, and delivery to patient. NV-387 oral gummies dissolve naturally in the mouth and do not require tablet swallowing, which is difficult for children, seniors, and also patients with sore throat.

If NV-387, as a broad-spectrum antiviral, is found to be effective against the Bundibugyo virus, it will likely be effective against all ebolaviruses or all filoviruses; that would be a game changer for pandemic preparedness.

Currently there is no treatment or vaccine for the Bundibugyo virus. All previous efforts have been focused on vaccines and antibodies[6]. This has led to approval of therapies that are specific to the Zaire strain only, albeit with limited effectiveness. This leaves out all other filoviruses of consequence: Sudan, Marburg, and the more rare Bundibugyo with no treatment or vaccine.

The US Government is active in ensuring that suspected or confirmed ebolavirus cases do not enter the general population in the USA. To this end, travel from DRC has been restricted, and suspect travelers are directed to screening at specific airports and may be quarantined.

The case fatality rate of ebolaviruses has generally been around 50% in recent outbreaks, with improvements in care, including hydration therapy, corticosteroids, and other usual symptomatic treatments. Ebola viruses spread via bodily fluid secretions including fomites/sputum, as well as semen/genital secretions. Ebola virus can remain in survivors even as many as 965 days after the disease without symptoms, and can transmit through bodily secretions, suggesting possible latency. Many recent outbreaks have been ignited as a result of such reawakened-transmitted virus from a survivor. Sexual transmission was documented even as late as 482 days after disease. This persistence and possible latency of ebolavirus in immune-privileged organs (e.g. brain, eyes, gonads, where antibodies are not operative) makes it a uniquely serious threat for global transmission and sustained outbreaks.

An irony is that because of the high case fatality rate (CFR) approaching 50%, the spread of ebolavirus remains rather limited. If a variant emerges with a reduced CFR, say in the range of 5-15%, the potential threat of global pandemic from such an outbreak would increase substantially. So far, BDBV has demonstrated variable CFR ranging from under 5% (in Uganda, 2026), to around 15% (in DRC), to over 35% (some specific parts of DRC). Therefore, BDBV is particularly of greater concern as a potential pandemic disease. However, it is believed that ebolaviruses do not transmit via respiratory droplets or aerosols, and require extensive contact with bodily fluids of an infected person. Currently there is no apparent threat of a global pandemic.

With ever-increasing global travel, local outbreaks such as ebola can quickly travel far and wide potentially causing global pandemics, as was the case with COVID-19, if not caught in time. It is not feasible to produce a new vaccine and a new set of antibody drugs to combat every possible virus. Even if vaccines and antibodies are produced, the virus would escape by generating variants, as the world has witnessed during the COVID-19 pandemic.

“Only safe and effective broad-spectrum antiviral drugs that can effectively combat most viral infections will enable the world to combat viruses and defend the global population in the war against known and unknown nanoscopic enemies that are viruses,” commented Dr. Diwan, adding, “NV-387 is the only drug with such potential that is in clinical development today, to the best of our knowledge.”

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]

[1] https://www.msn.com/en-us/health/other/congos-ebola-outbreak-spreads-to-two-more-provinces/ar-AA27NkjT

[2] https://virological.org/t/initial-genomes-from-may-2026-bundibugyo-virus-disease-outbreak-in-the-democratic-republic-of-the-congo-and-uganda/1032

[3] https://www.reuters.com/business/healthcare-pharmaceuticals/trial-bundibugyo-ebola-treatment-starts-drc-who-says-2026-07-02/

[4] https://www.cdc.gov/media/releases/2026/update-on-ebola-outbreak-in-the-democratic-republic-of-the-congo-and-uganda-6-5-2026.html

[5] https://www.forbes.com/sites/maryroeloffs/2026/05/25/african-health-officials-on-ebola-this-is-too-much-live-updates/

[6] Substantial work was also performed to develop small chemical potentially broad-spectrum agents. Remdesivir was the only small chemical that entered the PALM clinical trials ca. 2018-2019 but failed to show effectiveness. Small chemicals are readily escaped by viruses often with just single mutations.

SOURCE: NanoViricides

Release – Cadrenal Therapeutics’ Late-Breaking Phase 2 Data Demonstrate Greater Than 25% Reduction in Thrombotic Events in HIT for First-in-Class 12-LOX Inhibitor CAD-1005 at ISTH 2026 Congress

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Research News and Market Data on CVKD

  • Selected as one of three late-breakthrough abstracts: clinical trials and innovation in thrombosis, CAD-1005 took center stage before the global thrombosis community at the largest ISTH meeting in more than a decade.
  • Oral presentation by Principal Investigator Dr. Steven E. McKenzie highlighted CAD-1005 as the first randomized, blinded, placebo-controlled trial for Heparin-Induced Thrombocytopenia (HIT).
  • Phase 2 data demonstrate an absolute reduction of more than 25% in thrombotic events, supporting the clinical advancement of this Phase 3-ready program.
  • CAD-1005 targets a life-threatening immune-mediated clotting disorder, with an estimated $2 billion in peak annual revenue and no currently approved root-cause therapies.

PARIS, July 13, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for rare immunothrombotic conditions, announced today that late-breaking clinical data from the Phase 2 study of the first-in-class 12-lipoxygenase (12-LOX) inhibitor CAD-1005 were featured in a highly anticipated late-breaking oral presentation at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris.

This year’s ISTH Congress marked a historic milestone, bringing together clinicians, researchers, scientists, educators and industry leaders from around the world for five days of scientific discovery, collaboration and innovation in thrombosis, hemostasis and vascular biology. Drawing the largest in-person audience in more than a decade, the event attracted over 6,000 registrants and more than 3,100 abstract submissions. As the premier global gathering for cutting-edge scientific research, the ISTH late-breakthrough program is reserved for high-impact clinical trial results and first disclosures that may define future standards of care and clinical practice.

The oral presentation, titled “12-lipoxygenase inhibition with CAD-1005 (formerly known as VLX-1005) in heparin-induced thrombocytopenia,” was part of the high-profile session on clinical trials and breakthrough innovations. It marks a historic milestone as the first randomized, blinded, placebo-controlled clinical trial in patients with Heparin-Induced Thrombocytopenia (HIT).

“Targeting 12-lipoxygenase is a novel, highly selective therapeutic approach that is intended to address the root cause of immune-mediated platelet activation in HIT,” said Dr. Steven E. McKenzie. “The data we presented in Paris illustrated how CAD-1005 could fundamentally shift the treatment paradigm for acute thrombotic care. By showing an encouraging reduction in thrombotic events when added to standard anticoagulation, this therapy may offer a highly differentiated and desperately needed option for these high-risk patients. Clinicians from around the world were enthusiastic about this novel approach to a serious unmet medical need.”

Key Phase 2 Highlights Presented:

  • Addressing the Root Cause: Unlike standard-of-care anticoagulants that only reduce thrombin generation, CAD-1005 is designed to directly block the underlying 12-LOX immune signaling loop that drives antibody-mediated platelet activation.
  • Efficacy Signal: Patients treated with CAD-1005 experienced a reduction of more than 25% in new or worsening thrombotic events compared with the placebo arm (50% vs. >75%), despite the study not being sufficiently powered for statistical significance.
  • Safety Signal: No serious adverse events attributable to CAD-1005, no major bleeding in SRA+ patients, and no deaths. Treatment with CAD-1005 was associated with fewer thromboembolic events without an increase in major bleeding.
  • Paradigm Shift in Trial Design: The trial established that the traditional platelet count recovery rate is an inadequate surrogate for clinical efficacy, as thrombotic events continued to occur after recovery. This provides critical framework intelligence for Cadrenal’s upcoming pivotal Phase 3 registration trial.

“The selection of the Phase 2 study for a late-breaking presentation at ISTH underscores the scientific integrity and significant commercial potential of CAD-1005,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “With our recent financing, we are well-positioned to advance partnering opportunities for CAD-1005 and tecarfarin.”

CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) and Orphan Drug status from the European Medicines Agency (EMA).

About Heparin-Induced Thrombocytopenia (HIT)

HIT is an immune-mediated, prothrombotic adverse drug reaction in which antibodies against platelet factor 4-heparin complexes activate platelets via FcγRIIA receptors, triggering a cascade that can lead to life-threatening thrombosis. Current management relies on non-heparin anticoagulants, which reduce thrombin generation but do not directly address the underlying antibody-mediated platelet activation; new thrombosis remains a major clinical concern even with appropriate anticoagulant therapy.

About CAD-1005

CAD-1005 is a novel investigational therapeutic in development for the treatment of heparin-induced thrombocytopenia (HIT). CAD-1005 is designed to selectively inhibit 12-lipoxygenase (12-LOX), an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT. CAD-1005 is intended to be used alongside existing standards of care and is being developed to address the underlying biological mechanisms that drive disease progression. To view how CAD-1005 works in HIT, click https://vimeo.com/1209382706/7dde06dc08?share=copy&fl=sv&fe=ci

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is being investigated as a first-in-class 12-LOX inhibitor for heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration and orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also in development for chronic indications.

The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease, those with left ventricular assist devices, and potentially those with Kawasaki disease (KD), an acute, self-limited, febrile illness that primarily affects children <5 years old and is the leading cause of acquired heart disease in developed countries. Tecarfarin has also received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA).

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include, without limitation, statements such as targeting 12-lipoxygenase being a novel, highly selective therapeutic approach addressing the root cause of immune-mediated platelet activation in HIT; the data presented in Paris illustrating how CAD-1005 could fundamentally shift the treatment paradigm for acute thrombotic care; the therapy offering a highly differentiated and desperately needed option for these high-risk patients; the selection of the Phase 2 study for a late-breaking presentation at ISTH underscoring the scientific integrity and significant commercial potential of CAD-1005; and the Company being well-positioned to advance partnering opportunities for CAD-1005 and tecarfarin. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to enter into a partnership opportunity for CAD-1005 and tecarfarin; the ability to benefit from the commercial potential of CAD-1005; raise sufficient capital to continue progress of CAD-1005; the ability to advance directly to Phase 3 study evaluating CAD-1005 in patients with HIT; the ability to successfully design and complete the Phase 3 study and derive the results needed for an NDA submission; and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

For more information, please contact:

Lytham Partners, LLC, Robert Blum, Managing Partner, 602-889-9700, [email protected]

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Release – Ocugen, Inc. Announces Binding Term Sheet with Roots Pharmaceutical to License OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in the Middle East and North Africa

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Research News and Market Data on OCGN

July 13, 2026

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  • Cumulative sales milestones up to $255 million and modest upfront/near-term development milestones
  • Royalties equaling 22% of net sales
  • Ocugen to manufacture and supply OCU400

MALVERN, Pa., July 13, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the signing of a binding term sheet to negotiate and enter into a license 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 Retinitis Pigmentosa (RP), in the Middle East and North Africa (MENA) region.

Pursuant to the term sheet, under the license agreement, Ocugen is expected to receive upfront license fees and near-term development milestone payments totaling up to $4 million. The Company would be entitled to sales milestone payments up to $255 million, in addition to a 22% royalty on net sales of OCU400 generated by Ocugen’s partner. Additionally, Ocugen would manufacture commercial supply of OCU400 under the terms of a related supply agreement.

RP is a leading cause of inherited vision loss globally, with notable prevalence across the MENA region, underscoring the significant unmet need OCU400 is positioned to address through this partnership.

“This step forward represents an important milestone in our effort to advance OCU400 regional partnership strategy,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “By partnering with an established leader with strong reach across the Middle East and North Africa, we are expanding our ability to bring this one-time potential treatment for life to a region where RP is highly prevalent with a significant unmet medical need where patients are desperately looking for rescue from blindness. This agreement underscores the momentum behind OCU400 and our continued commitment to patients.”   

“Bringing innovative gene therapies to patients across the MENA region is a strategic imperative for Roots Pharmaceutical and its strategic partner Al-Dhow International Holding,” said Dr. Islam Zayed, CEO & Co founder of Roots Pharmaceutical. Dr.Zayed emphasized that “ OCU400 built on our legacy of bringing Rare Disease therapies to patients in MENA and enables our combined teams to decrease disease burden in the region. Importantly, Roots is dedicated to bringing OCU400 to patients with Retinitis Pigmentosa and creating a new treatment paradigm. We are excited to partner with the Ocugen team.”

Additional details will be available once the definitive agreement between the parties is executed, which is expected to occur within the next 90 days.

Ocugen continues to advance OCU400 through its Phase 3 liMeliGhT clinical development with a topline readout expected in 1Q 2027 and BLA submission to follow.

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late-stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.

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 terms of the definitive license and supply agreement with Roots Pharmaceutical, the timing of entering into such definitive agreement or whether such definitive agreement will be executed at all, the anticipated benefits to Ocugen of such definitive agreement, qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, 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 the definitive license and supply agreement with Roots Pharmaceutical will be delayed or not executed at all, or that, if executed, it will not be on terms described above, the risk that such definitive agreement, if executed, will not lead to the currently anticipated benefits to Ocugen, the risks 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 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 periodic 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.

Investor Contact:
Candice Masse
astr partners
[email protected]

Release – Tonix Pharmaceuticals Announces Major Managed Medicare Payer Agreement for TONMYA®

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July 13, 2026 7:00am EDTDownload as PDF

New agreement, effective January 1, 2027, to add approximately 9 million Medicare lives (16% of approximately 55 million Medicare lives in the U.S.)

On top of two previously announced major commercial payer agreements and Medicaid availability in most states, pharmacy coverage for TONMYA will total approximately 46% of all covered lives in the U.S.

Sales force expansion underway with additional field deployment expected by mid-third quarter 2026

BERKELEY HEIGHTS, N.J., July 13, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or “the Company”), a fully integrated, commercial-stage biotechnology company, today announced a major managed Medicare agreement for TONMYA® (cyclobenzaprine HCl sublingual tablets), adding approximately 9 million Medicare lives (16% of approximately 55 million Medicare lives in the U.S.). The new agreement will go into effect on January 1, 2027. On top of two prior commercial coverage agreements with leading group purchasing organizations (GPOs) effective in the second quarter of 2026, and Medicaid availability in most states representing approximately 73 million lives, pharmacy coverage for TONMYA on January 1, 2027, will total approximately 145 million covered lives (46% of 314 million covered lives). Discussions with other commercial and Medicare payers continue to advance.

Following these coverage milestones and positive trends across the launch’s key performance indicators, Tonix is executing its strategy to incrementally grow the TONMYA sales force and expects to deploy 50 new sales force representatives in the field by mid-third quarter 2026, bringing the full sales force to approximately 150 people.

“Patient access to TONMYA is accelerating with the new Medicare agreement on top of two previously announced commercial coverage wins in the first two full quarters of launch,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Having gained substantial patient access, we are expanding our sales force. We believe we are strongly positioned to address patients’ interest in an alternative fibromyalgia medicine and realize the significant potential of the TONMYA opportunity. TONMYA is a first-in-class, non-opioid analgesic designed for daily bedtime administration and long-term use that could serve as an important treatment option.”

Thomas Englese, MBA, Executive Vice President, Commercial Operations, added, “Our coverage growth reflects the recognition of TONMYA’s value for patients and healthcare prescribers (HCPs). Alongside this progress, we are also seeing positive signals across our launch key metrics, including new prescribers, new patients initiating treatment, total prescriptions, and refill prescriptions. By scaling our field team, we expect to engage more top-target HCPs through increased breadth and frequency. We are simultaneously expanding marketing and medical affairs activities to develop greater understanding of fibromyalgia and TONMYA among patients and HCPs. We remain focused on operational excellence and execution.”

About Fibromyalgia

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts more than 10 million adults in the U.S., predominantly women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

About TONMYA® (cyclobenzaprine HCl sublingual tablets)

TONMYA (cyclobenzaprine HCl sublingual tablets) was approved on August 15, 2025, by the U.S. Food and Drug Administration (FDA) for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. TONMYA provides rapid transmucosal absorption of cyclobenzaprine and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypassing first-pass hepatic metabolism. TONMYA is a multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, alpha1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. TONMYA was investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress disorder (ASD)/acute stress reaction (ASR), and major depressive disorder (MDD). The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TONMYA composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first new 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 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, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. 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 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. 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.

Contacts
Deborah Elson (Investors/Media)
Tonix Pharmaceuticals
[email protected]
[email protected]  

Brian Korb (Investors)
astr partners
(917) 653-5122
[email protected]

Andrea Cohen (Media)
Sam Brown Inc.
(917) 209-7163
[email protected]

INDICATION
TONMYA is indicated for the treatment of fibromyalgia in adults.

CONTRAINDICATIONS
TONMYA is contraindicated:

In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.

During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism.

WARNINGS AND PRECAUTIONS
Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.

Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.

Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.

Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.

CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

DRUG INTERACTIONS
MAO inhibitors: Life-threatening interactions may occur.

Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.

USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).

Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.

Pediatric use: The safety and effectiveness of TONMYA have not been established.

Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.

Please see additional safety information in the full Prescribing Information. To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

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Source: Tonix Pharmaceuticals Holding Corp.

Released July 13, 2026

Release – Greenwich LifeSciences Announces European Approval for Use of Commercially Manufactured GP2 in FLAMINGO-01

Posted on by [email protected]
Greenwich LifeSciences

Research News and Market Data on GLSI

 Download as PDF July 09, 2026 6:00am EDT

STAFFORD, Texas, July 09, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following update on the use of commercially manufactured GP2 in FLAMINGO-01 in Europe.

All European and US Sites to Treat Patients with Commercially Manufactured GP2

The Company previously announced that the first three commercial lots of GP2 active ingredient were manufactured in 2023 in an approved commercial facility, which could be used to prepare approximately 200,000 doses of GP2. In 2024, the first commercial lot filling GP2 into vials for commercial sale or for clinical use was manufactured in a commercial facility. In addition, drug stability programs were initiated for all four lots. Data on these commercial lots was submitted to the FDA, and after review, the first commercial lot of GP2 vials was approved for use in FLAMINGO-01 in the US in early 2026. All approximately 40-50 US sites have been supplied with commercially manufactured GP2 vials and have begun treating patients with these vials. We were able to efficiently distribute the GP2 vials and communicate with the US pharmacists working with our warehouse partners and through our clinical team, which we internalized in Q4 2025.

The European Medicines Agency (EMA) has completed their review and will also allow use of the same commercially manufactured GP2 lot in FLAMINGO-01 in Europe. Thus, all clinical sites in the US and Europe, which have increased from 160 sites to approximately 170-180 sites, are expected to be using the same lot with shipments to European pharmacies already under way. We are now seeking approval to use this lot in the UK and Canada in separate and independent regulatory processes.

About FLAMINGO-01 Open Label Phase III Data

More than 1,300 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

  • In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
  • This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
  • The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
    • The AACR Meeting 2026 delayed-type-hypersensitivity (DTH) poster and the ASCO Meeting 2026 injection site reaction (ISR) poster can be seen and downloaded at the bottom of the Phase III clinical trial tab on the Company’s website here.
    • As shown in both posters the frequency of DTH and ISR reactions increased statistically significantly over time.
    • As reported in Table 1 of each poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline.
    • Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb posters and results can be summarized as follows and can be seen here:

  • 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
  • The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 170-180 sites globally.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

About Greenwich LifeSciences, Inc.

Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.

Forward-Looking Statement Disclaimer

Statements in this press release contain “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 Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.

Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: [email protected]

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: [email protected]

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Source: Greenwich LifeSciences, Inc.

Released July 9, 2026

MAIA Biotechnology (MAIA) – First Data From Phase 2 Part C Trial Shows Data Consistent With Earlier Studies

Posted on by [email protected]


Thursday, July 09, 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.

Data From Part C Announced. MAIA announced data from Part C (Expansion stage) of its Phase 2 THIO-101 trial in non-small cell lung cancer (NSCLC). This open-label stage of the trial tests the combination of ateganosine and cemiplimab (Libtayo, from Regeneron) as a third-line (3L) therapy for patients with advanced disease that no longer respond to other therapies. The data after the first evaluation have a Disease Control Rate (DCR) of 90.5% (19 out of 21 patients), compared with published rates of 25% to 35%. We view this as a good sign that patient responses are consistent with previous data.

Design Of the Phase 2 THIO-101 Trial. The Phase 2 THIO-101 Expansion stage is the third part of the Phase 2 trial. Part A tested safety, while Part B was for dose optimization and selection. Part C is currently testing the combination of the 180 mg dose of ateganosine with cemiplimab. If positive, the data could be used to apply for accelerated approval from the FDA.


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Release – MAIA Biotechnology Reports Strong Initial Efficacy Data in Third-Line Non-Small Cell Lung Cancer from Phase 2 THIO-101 Part C Expansion Trial

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

July 08, 2026 9:45am EDT Download as PDF

90.5% interim disease control rate (DCR) observed with combination therapy

Initial Part C efficacy observations align with previously reported THIO-101 clinical activity despite a more heavily pre-treated patient population

CHICAGO, July 08, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced positive initial efficacy data from its Phase 2 THIO-101 clinical trial expansion, Part C, evaluating its lead candidate, ateganosine, a dual mechanism of action drug incorporating telomere targeting and immunogenicity, as a third-line (3L) therapy for patients with advanced non-small cell lung cancer (NSCLC). 

Initial data from the THIO-101 Part C 3L studies1 show a disease control rate (DCR) of 90.5% (19 out of 21 patients) in the efficacy evaluable population who had at least one tumor scan after starting treatment. Patients are treated with ateganosine followed by cemiplimab (Libtayo®) in cycles of 21 days. Current chemotherapy treatments deliver an approximate 25-35% disease control rate.2

“The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy treatment,” said Vlad Vitoc, Founder and Chief Executive Officer of MAIA Biotechnology. “Importantly, patients enrolled in Part C of our trial represent a more heavily pre-treated population, with all patients having previously received docetaxel in addition to demonstrating resistance to both immunotherapy and other chemotherapies.”

MAIA recently announced that it has completed international enrollment in Part C of the Phase 2 THIO-101 expansion trial. Treatment with ateganosine followed by cemiplimab has shown an acceptable safety profile to date in a heavily pre-treated population.

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 THIO-101 Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

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
[email protected]

1 As of July 06, 2026
2 Matsumoto H, et al. Transl Lung Cancer Res 2021;10:2278–89

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Source: MAIA Biotechnology, Inc.

Released July 8, 2026

Release – Research Analyst Report on NanoViricides Rates Company “Outperform”; Separately, A “Fireside Chat” Interview of the Company’s President Dr. Anil Diwan Hosted by Mr. Dave Donlin was Published by StockInvestor Daily

Posted on by [email protected]
Research Analyst Report on NanoViricides Rates Company "Outperform"; Separately, A "Fireside Chat" Interview of the Company's President Dr. Anil Diwan Hosted by Mr. Dave Donlin was Published by StockInvestor Daily

Research News and Market Data on NNVC

Wednesday, 08 July 2026 08:30 AM

Topic: 

Company Update

SHELTON, CT / ACCESS Newswire / July 8, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), a clinical stage leader developing antiviral drugs that viruses cannot escape, reports that a Coverage Initiating Research Report on the Company by an Independent Analyst has been published, dated as of July 6, 2026.

The report rates the Company with a rating of “Outperform” and has assigned a target price of $6.00, based on the analyst’s estimates. This research report provides a summary of the Company’s current programs, as well as additional longer term programs. The report was written by Mr. Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc. The report and additional coverage of the Company is available at channelchek.com. The report is also available at the Company’s website, nanoviricides.com .

The Company provided publicly available information to the Analyst, and also provided answers to questions of a technical nature, as is typical. All estimates of timelines, financial projections and modeling, etc. were made independently by the Analyst. The Company does not provide guidance on its timelines or revenues, profit or loss projections, nor does it review or have any input into the independent assessments.

The Company has retained Noble Capital as part of its investor outreach program. No part of the Analyst’s compensation was, is, or will be directly or indirectly related to any specific recommendations or views expressed in the public appearance and/or research report. All views expressed in this report accurately reflect the Analyst’s personal views about the subject securities or issuers. This report is intended to provide general securities advice, and does not purport to make any recommendation that any securities transaction is appropriate for any recipient particular investment objectives, financial situation or particular needs.

In a separate update, NanoViricides reports that Anil R. Diwan, PhD, the Company’s President and Executive Chairman was interviewed in a “Fireside Chat” by host Mr. Dave Donlin. This video interview was published by StockInvestor Daily under the IPO-Edge program on June 29, 2026 and is available at https://ipo-edge.com/replay-fireside-chat-with-nanoviricides-president-exec-chairman-anil-r-diwan/. The video is also available on the Company’s website (nanoviricides.com). The video provides information on the Company’s technology, how it is differentiated from current approaches, and the current programs.

In this Fireside Chat, Dr. Diwan discussed:

  • How NanoViricides’ broad-spectrum antiviral drugs like its lead drug NV-387 work alongside vaccines.
  • NanoViricides advancing a broad-spectrum antiviral approach that will be effective even against variants with its lead drug NV-387; how this differs from current antivirals in treating viral diseases like RSV and FLU.
  • The company’s Orphan Drug Designation granted by the FDA and its filing for Rare Pediatric Disease Designation for Measles; how the Company benefits from these designations and the upcoming potential funding benefits.
  • The resurgence of Measles despite having a vaccine in place and how it has caused epidemics in Europe, Canada, Mexico, and Bangladesh, while also making headlines in the U.S. Why this is happening and what this return tell us about current protection against viral diseases that are thought to be eliminated by vaccines.
  • The resurgence of several viral infections globally, like Monkeypox and Ebola, and the WHO declaring global alerts as diseases come back with new virus variants for which there is no vaccine or treatment, and how NanoViricides can help.

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]

SOURCE: NanoViricides, Inc.

Release – The Oncology Institute Completes Strategic Refinancing with OrbiMed, Repaying the Outstanding $86 Million Deerfield Convertible Note, Strengthening its Balance Sheet, and Improving Liquidity

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

Jul 07, 2026

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CERRITOS, Calif., July 07, 2026 (GLOBE NEWSWIRE) — The Oncology Institute, Inc. (“TOI”) (NASDAQ: TOI), one of the largest value-based oncology groups in the United States, announced today that it has repaid its $86 Million senior secured convertible note with Deerfield Partners through a debt refinancing that includes new credit facilities from OrbiMed.

This transaction is intended to increase liquidity, improve operating flexibility and extend debt maturities. Under the new financing arrangements with OrbiMed, TOI repaid the outstanding balance of its $86 million senior secured convertible note with a new $75 million term loan with OrbiMed maturing in 2031 as well as approximately $11 million of cash from the balance sheet without raising additional equity. Daniel Virnich, MD, CEO of TOI, commented, “I’m extremely excited about our new financing relationship with OrbiMed to support this next phase of TOI’s growth and business model refinement. In addition to providing the company with improved liquidity and financial flexibility, this important transaction significantly extends debt maturities and establishes committed funding from two leading healthcare financing institutions.” Dr Virnich also commented, “We are very pleased that we were able to complete these transactions without diluting our important existing shareholders, and would like to thank Deerfield Healthcare for their many years of support to TOI as both a creditor and existing shareholder.”

“We are pleased to support TOI in its next phase of growth,” said Matthew Rizzo of OrbiMed. ” We are excited to play a role in TOI’s expansion and development as it continues to scale and drive long term value for its patients and contracted payors.”

About The Oncology Institute  (www.theoncologyinstitute.com):

Founded in 2007, The Oncology Institute, Inc. (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 2.0 million patients including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 400 employed and network clinicians and over 100 clinics and network locations of care across five states and growing, TOI is changing oncology for the better. For more information visit www.theoncologyinstitute.com.

Forward Looking Statement

This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or TOI’s future financial or operating performance and are often identified by words such as “believe,” “expect,” “anticipate,” “plan,” “intend,” “may,” “will,” “estimate,” “continue,” “project,” “target,” or similar expressions.

These forward-looking statements include, without limitation, statements regarding TOI’s growth strategy, liquidity, working capital needs, access to financing (including any asset-based credit facilities), expected operational and financial performance, and market opportunities. These statements are based on current expectations, assumptions, and information available to management and are not guarantees of future performance.

Actual results may differ materially from those expressed or implied in forward-looking statements due to a variety of risks and uncertainties, including, among others: changes in the healthcare regulatory environment; reimbursement and payor dynamics; competitive pressures; TOI’s ability to execute on its growth and value-based care strategy; access to capital and liquidity; and the impact of litigation, government investigations, or other proceedings.

Additional factors that could cause actual results to differ materially are described in TOI’s filings with the Securities and Exchange Commission, including the “Risk Factors” section of TOI’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.

Forward-looking statements speak only as of the date made, and TOI undertakes no obligation to update or revise these statements to reflect events or circumstances occurring after the date of this communication, except as required by law.

Media
The Oncology Institute, Inc.
[email protected]

Investors
ICR Healthcare
[email protected]

Release – MariMed’s Nature’s Heritage Launches “The Nose Knows” Immersive, Science-Backed Consumer Education Campaign

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

July 07, 2026 7:00am EDTDownload as PDF

NORWOOD, Mass., July 07, 2026 (GLOBE NEWSWIRE) — MariMed’s (“MariMed”) (CSE: MRMD) (OTCQB: MRMD) award-winning flower, vape and concentrate brand, Nature’s Heritage™, today announced the launch of ‘The Nose Knows,’ an immersive, science-backed consumer education campaign designed to help consumers better understand which cannabis products and strains align best to their preferences. The campaign aims to educate consumers about the critical role aroma plays in delivering desired cannabis experiences and organizes cannabis strains into six categorizes to make purchase decisions easier and more effective.

Developed in collaboration with Dr. Riley Kirk, a PhD-trained pharmaceutical scientist specializing in cannabis and pharmacology, ‘The Nose Knows’ campaign was inspired by feedback from cannabis consumers surveyed across Massachusetts, Maryland, and Illinois. The survey found that a product’s THC potency percentage is the primary factor influencing purchases. According to Dr. Kirk, research indicates that consumers would achieve a more desirable and personalized experience by focusing instead on their natural attraction to certain scents when making their flower purchase.

“Our sense of smell is intimately tied to our brain’s processing centers for emotions and memory,” said Dr. Kirk. “We want to encourage people to follow their nose to find cannabis that fits their needs and allows for a more personalized and nuanced experience. Terpene labels are a great resource, but they can be confusing to consumers. Following your nose is simple and intuitive for everyone.”

‘The Nose Knows’ campaign features immersive in-store activations, sensory-driven displays, and large-scale murals highlighting six aroma-and-effect-driven categories: Jacks & Haze, Tropical & Citrus, Floral & Earthy, Desserts & Sweets, OG, Gas & Chem, and Exotics. Utilizing local artists to visually depict each intended experience, the campaign transforms participating retail spaces into educational environments that encourage consumers to smell flower and concentrates and use their nose to help discover products that are right for them. Consumers can also explore the campaign through Nature’s Heritage’s online “Find Your Flower” quiz. The quiz helps guide consumers toward products aligned with their preferences and desired effects.

“Today’s cannabis consumer overwhelmingly purchases products based on THC percentage. Cannabis is meant to be experienced through one’s senses, and the science supports the fact that focusing on aroma rather than potency will enhance a consumer’s cannabis experience,” said Tami Kirlis, Brand Director for Nature’s Heritage. “We developed ‘The Nose Knows’ campaign to educate consumers and shift their purchasing behaviors using their sense of smell.”

To learn more about Nature Heritage, including options for flower, RSO, concentrates and vapes, visit www.naturesheritagecannabis.com.

About MariMed
MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, InHouse™, Nature’s Heritage™, and Vibations™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.

Media Contact:
Zach Galasso
DPA Communications 
Email: [email protected]
Phone: (978) 604-5423

Company Contact:
Howard Schacter
Chief Communications Officer 
Email: [email protected]
Phone: (781) 277-0007

Release – NeuroSense to Participate in Roth-Hosted KOL Webinar on the Future of ALS Treatment: “A Quest to Outrun ALS”

Posted on by [email protected]

Research News and Market Data on NRSN

Featuring renowned ALS expert Prof. Jeremy Shefner, the discussion will address key unmet needs in ALS, trial endpoint design, and PrimeC’s path forward

CAMBRIDGE, Mass., July 6, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced its participation in a key opinion leader (KOL) webinar hosted by Roth Capital Partners titled “A Quest to Outrun Amyotrophic Lateral Sclerosis (ALS).” The webinar will bring together leading experts to discuss the current treatment landscape for ALS, persistent unmet medical needs, and emerging therapeutic approaches with the potential to change the course of the disease.

The live webinar will take place on Wednesday, July 8, 2026, at 11:00 a.m. Eastern Time and will be hosted by Boobalan Pachaiyappan, Ph.D., Managing Director and Senior Research Analyst at Roth Capital Partners, who covers the biotechnology sector. The discussion will feature Professor Jeremy Shefner, M.D., Ph.D., Chair of Neurology at Barrow Neurological Institute and Co-Founder of the Northeast ALS Consortium (NEALS), together with Alon Ben-Noon, Chief Executive Officer of NeuroSense.

To join the conversation, register in advance here.

The webinar will explore the most pressing questions in ALS drug development today – from the persistent unmet needs that continue to challenge patients and clinicians, to the clinical trial endpoints that may better capture disease progression. The discussion will also examine how NeuroSense’s PrimeC is positioned – mechanistically and clinically – relative to the current standard of care, what the pivotal Phase 3 PARAGON study will aim to demonstrate on the path toward potential FDA accelerated approval, and PrimeC’s longer-term commercial opportunity within an evolving ALS treatment landscape.

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 generated compelling clinical data from its Phase 2b PARADIGM study in ALS, demonstrating meaningful slowing of disease progression. The Company also reported significant biological activity across multiple biomarkers associated with ALS, including microRNAs, supporting PrimeC’s multi-target mechanism of action. Notably, long-term follow-up data indicated a meaningful survival benefit, representing a potentially important advancement in the treatment of ALS.

NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a pivotal Phase 3 clinical trial (PARAGON) in ALS, which is expected to enroll approximately 300 participants, primarily in the United States.

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 synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 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.

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. Further, certain forward-looking statements, including statements regarding the planned event, development, regulatory progress and potential commercialization of PrimeC, 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 uncertainty regarding the benefits of outcomes and the timing of current and future clinical trials; timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; 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.

Logo: https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg

SOURCE NeuroSense

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

NanoViricides (NNVC) – Novel Technology With Broad-Spectrum Antiviral Applications In Development

Posted on by [email protected]


Monday, July 06, 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.

We Are Initiating Coverage With An Outperform Rating. NanoViricides has a proprietary technology platform that it has used to formulate antivirals with a unique mechanism of action. These drugs, called nanoviricides, have been designed to carry a peptide sequence that the virus recognizes as a binding site on a host cell, effectively acting as decoys that the virus binds to instead of healthy cells. Once bound to the drug, the virus is trapped and neutralized.

NV-387 Addresses Viral Outbreaks and Pandemic Preparedness. The lead product, NV-387, is in development for MPox, Ebola, and smallpox. A Phase 2a trial evaluating NV-387 for treating MPox in the Democratic Republic of Congo (DRC) is expected to begin treatment in mid-2027, followed by a Phase 2a in Ebola. Initial data is expected to be available toward the end of 2027.


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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 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. 

NeuroSense Therapeutics Ltd. (NRSN) – Strong PrimeC Data Continues As Phase 2b PRAADIGM Study Meets Primary Endpoint In ALS With Reduction

Posted on by [email protected]


Thursday, July 02, 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.

NeuroSense Reported Strong Phase 2b PARADIGM Data. Results of the Phase 2b PARDIDM study testing PrimeC in ALS met its primary endpoint of a statistically significant reduction in TDP-43 at six months. The reduction in neuron-derived TDP-43 in the treated group indicates that PrimeC affects an important mechanism of disease and the underlying cause of ALS. To our knowledge, this is the first clinical trial to show that a drug could reduce TDP-43 in people living with ALS.

Phase 2b PARADIGM Study Tested Functional and Biological Endpoints. The trial was a double-blind trial enrolling 68 patients with confirmed ALS. Patients were randomized 2:1 to receive either PrimeC or a placebo for 6 months. All patients then received PrimeC for the next 12 months (18 months total). The trial endpoints included TDP-43, safety, tolerability,  and biomarkers of disease.


Get the Full Report

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.