Category: Health

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

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Thursday, September 24, 2026

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

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

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

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


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*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. 

Eledon Pharmaceuticals (ELDN) – Tegoprubart Extension Study Maintains Improvement Over Tacrolimus

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Wednesday, September 23, 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.

Long-Term Data Updated At Transplant Conference. Eledon presented an update to the Phase 2 BESTOW Extension study at the International Congress of The Transplantation Society. Analysis up to 24 months after transplantation showed that patients treated with tegoprubart had statistically significant improvements in kidney function compared with patients treated with tacrolimus. Separately, tegoprubart has also received Fast Track designation from the FDA in the kidney transplant indication.

Updated Extension Study Data. Patients completing the BESTOW trial were entered into an Extension Stage to follow outcomes after the trial period ended. At 18, 21, and 24 months, tegoprubart patients had a higher eGFR of about 71 mL/min/1.73m2 compared with 58 mL/min/1.73m2 for tacrolimus, with differences that were statistically significant. Tegoprubart patients showed a continued improvement in eGFR after the trial, while tacrolimus patients showed a gradual but steady decline.


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

MAIA Biotechnology (MAIA) – Heading Into 4Q After Strong Clinical Progress

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Tuesday, September 22, 2026

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

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

Phase 2 Extension Stage Has Begun Treatment At US Sites. MAIA began treating patients at three US sites in the Part C Expansion Phase of its Phase 2 THIO-101 trial. The trial tests ateganosine (aka THIO) in non-small cell lung cancer (NSCLC) and had completed the planned patient enrollment at international sites worldwide. Two additional US sites are expected to open during 2026.

Initial Data Shows Consistent Efficacy. In June 2026, MAIA announced initial efficacy data from the ongoing Phase 2 THIO-101 Part C Expansion Stage. Patients with at least one post-treatment evaluation by tumor scan showed a disease control rate (DCR) of 90.5% in the evaluable population. We believe that data consistent with Parts A and B could allow the company to apply for Accelerated Approval and Priority Review.


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Ocugen (OCGN) – Interim Analysis Report Recommends Continuing Stargardt Phase 2/3 Trial, But Causes Confusion

Posted on by cpatches


Thursday, September 10, 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.

The DMC Recommends Continuing The GARDian Trial. Data Monitoring Committee (DMC) has completed its planned interim analysis of the Phase 2/3 GARDian trial of OCU410ST in Stargardt disease. The analysis included 26 patients out of the planned enrollment of about 50, evaluating 16 treated patients and 10 controls. The DMC recommended continuing the trial as planned, with an evaluation of the entire patient population at 8 months after treatment. We believe the disclosure has led to misinterpretation of the recommendation.

The Evaluation Included Just Half The Enrollment In An Orphan-Sized Trial. Stargardt is an Orphan disease with a Phase 2/3 trial based on a small enrollment of about 50 patients. While this helps enrollment, each patient’s data has a larger impact than in larger trials.


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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.

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Are We Getting Closer to a Scalable Cure for Type 1 Diabetes?

Posted on by cpatches

For more than a century, insulin has transformed type 1 diabetes from an almost invariably fatal disease into a manageable chronic condition. Pumps, continuous glucose monitors and automated insulin delivery systems have made that management increasingly sophisticated.

But none replaces what the disease destroys: the insulin-producing cells of the pancreas.

A growing field of biotechnology companies is now trying to do exactly that.

The emerging strategy, known broadly as islet cell replacement therapy, seeks to restore the body’s ability to produce insulin by replacing the pancreatic islet cells lost to type 1 diabetes. Recent clinical results have provided some of the strongest evidence yet that the fundamental concept works. At the same time, advances in stem-cell manufacturing, immune modulation and gene engineering are beginning to address the obstacles that historically prevented islet transplantation from becoming a broadly available treatment for the type 1 diabetes population.

A merger announced Tuesday between Sernova Biotherapeutics (TSX:SVA) and Seraxis Holdings (private) provides the latest example of how the field is evolving. The companies plan to combine to form BetaNova Biotherapeutics, bringing together stem-cell-derived pancreatic islets, scalable manufacturing, an implantable cell-delivery platform and next-generation approaches with and without immune protection.

The transaction comes amid accelerating development across the industry, including programs from Vertex Pharmaceuticals, Sana Biotechnology, Century Therapeutics, Eledon Pharmaceuticals and NewcelX.

Taken together, the activity raises an increasingly serious question: Is type 1 diabetes moving toward a functional cure that can eventually be manufactured at scale?

The Biology Has Already Shown It Can Work

Type 1 diabetes occurs when the immune system destroys the insulin-producing beta cells contained within pancreatic islets. Without those cells, patients must continuously replace the insulin their bodies can no longer produce.

Replacing the missing insulin-producing cells is therefore an unusually direct therapeutic concept.

Traditional islet transplantation has already demonstrated that transplanted cells can restore insulin production. In 2023, the FDA approved Lantidra, a therapy made from pancreatic islets isolated from deceased donors, for a limited group of adults with type 1 diabetes experiencing recurrent severe hypoglycemia despite intensive management.

In clinical studies supporting Lantidra, 21 of 30 treated patients achieved insulin independence for at least one year, including 10 who remained insulin independent for more than five years.

That was an important validation of the biology.

It was not, however, the scalable solution researchers ultimately want.

Donor-derived islets are constrained by the availability of deceased-donor pancreases. Recipients also generally require chronic immunosuppressive drugs to prevent rejection of the transplanted cells, exposing otherwise healthy patients to potentially serious long-term risks.

Those two limitations — cell supply and immune rejection — now define much of the race in type 1 diabetes cell therapy.

Stem Cells Change the Supply Equation

Stem-cell technology potentially solves the first problem.

Instead of relying on donated organs, companies can begin with stem cells capable of reproducing extensively and then differentiate them into pancreatic islet cells. In principle, that creates a renewable manufacturing source capable of producing standardized, off-the-shelf therapies.

There is now meaningful human evidence that those cells can work.

Vertex Pharmaceuticals’ (NASDAQ: VRTX) Zimislecel, formerly known as VX-880, is currently the most advanced stem-cell-derived islet program in the field. In previously reported Phase 1/2 results, all 12 patients receiving a full dose demonstrated engraftment and glucose-responsive insulin production. Ten of the 12 were no longer using exogenous insulin after one year, while all 12 achieved recommended HbA1c and time-in-range targets and experienced no severe hypoglycemic events after Day 90. The results were published in the New England Journal of Medicine.

Vertex is continuing to enroll and dose patients in its Phase 1/2/3 study in 2026.

The importance of that program extends beyond Vertex itself. It has provided clinical evidence that fully differentiated pancreatic islet cells manufactured from stem cells can restore physiological insulin production in humans.

The catch is that Zimislecel still relies on conventional immunosuppression.

That leaves the industry’s second major problem unresolved.

BetaNova Combines the Pieces

That challenge helps explain the rationale behind the newly announced combination of Sernova and Seraxis.

After the merger closes, expected in November, shareholders of each company are expected to own about half of BetaNova. The company also secured commitments for a $10 million financing intended to advance its initial development programs.

Seraxis brings SR-02, an allogeneic stem-cell-derived pancreatic islet product, together with in-house cGMP manufacturing capabilities designed to produce cells at clinical scale.

Sernova contributes its Cell Pouch Bio-hybrid Organ, an implantable and retrievable device designed to provide an environment where therapeutic cells can engraft, vascularize, survive and function. Sernova has already completed patient treatment and follow-up in a Phase 1/2 study using the device with donor-derived pancreatic islets. According to the company, it met all primary and secondary endpoints.

BetaNova intends to combine those technologies.

SR-02 is expected to enter a Phase 1/2 study in the first quarter of 2027 under an FDA-cleared IND, with initial data anticipated by midyear.

A second program, SR-03, takes the strategy one step further by incorporating gene edits intended to allow the transplanted islets to evade immune destruction. BetaNova expects to submit an IND for SR-03 in the second half of 2027.

In other words, the merger brings several of the pieces required for a scalable therapy under one roof: a renewable cell source, controlled manufacturing, a clinically tested implantation platform and an immune-evasion strategy.

Eledon Attacks the Immune Problem From a Different Direction

Not every company believes the cells themselves need to be invisible to the immune system.

Eledon Pharmaceuticals (NASDAQ: ELDN) is developing tegoprubart, an investigational anti-CD40L antibody designed to modulate a critical pathway involved in immune activation.

Results from an investigator-sponsored study at the University of Chicago have attracted particular attention. Twelve patients with type 1 diabetes received donor-derived pancreatic islet transplants while using a tegoprubart-based, calcineurin inhibitor-free immunosuppression regimen.

As of June 2026, all 12 patients had achieved insulin independence, all had HbA1c levels below 6.5%, and none had experienced severe hypoglycemic episodes following transplantation. The patients had entered the study with histories of recurrent severe hypoglycemia.

That study does not solve the supply problem. The islet cells still come from donors, but it may provide another piece of the scalability puzzle: a more favorable way to protect transplanted cells.

Eledon has since moved toward a registrational pathway. On September 3, the company announced that it had submitted an IND for its first company-sponsored study of tegoprubart in patients with type 1 diabetes undergoing islet transplantation.

That same announcement pointed to a broader ambition. Eledon reaffirmed that it remains on track to initiate LEGACY, a global Phase 3 trial of tegoprubart in kidney transplantation, in the fourth quarter of 2026, following a successful End-of-Phase 2 meeting with the FDA. LEGACY is expected to enroll approximately 600 patients, with a primary endpoint of non-inferiority to tacrolimus at 52 weeks on a composite of biopsy-proven acute rejection, graft loss and death. Eledon has also reported first patients dosed with tegoprubart under compassionate-use protocols in highly sensitized kidney transplant recipients and in islet-transplant recipients with calcineurin-related kidney dysfunction, alongside an investigator-initiated tolerance-induction study at Massachusetts General Hospital.

Taken together, that pipeline suggests Eledon is no longer positioning tegoprubart as a single-indication kidney transplant drug. It is increasingly framed as a platform immunosuppressant intended to compete with calcineurin inhibitors as first-line therapy across kidney and islet transplantation alike.

That clinical progress stands out next to how the private market is pricing an earlier-stage rival chasing the same broad opportunity. LifeMine Therapeutics (private) is developing LIFE-001, a calcineurin activation inhibitor aimed at replacing tacrolimus and cyclosporine across transplantation generally, but has not yet begun the Phase 2 kidney or Phase 1b islet studies that would put it on comparable clinical footing with Eledon.

Yet according to PitchBook, LifeMine’s August Series E, led by Milky Way Investments Group with new investors Bezos Expeditions, Gates Frontier and RA Capital Management, closed at a $700 million post-money valuation, roughly three times Eledon’s public market capitalization of approximately $240 million-$250 million. The comparison is not a clean one: LifeMine’s figure prices preferred shares carrying a 1x participating liquidation preference and weighted-average anti-dilution protection, terms that can support a higher headline valuation than a common-equity holder would assign the same business, so it is not directly comparable to Eledon’s common-stock market cap.

Even so, the gap is notable: a private company with no islet-transplant data of its own has been valued well above a Nasdaq-listed company that already has 12-patient investigator-sponsored islet results, a submitted IND for a company-sponsored islet study, and a global Phase 3 kidney trial about to begin. For investors, that disconnect is one lens for weighing whether Eledon’s public valuation fully reflects its clinical progress.

Readers can find equity research coverage on Eledon’s Channelchek research page.

NewcelX Pairs Stem-Derived Islets With Tegoprubart

NewcelX is developing another approach combining a renewable source of islet cells with Eledon’s immune-modulation strategy.

Its lead diabetes candidate, NCEL-101, is an enriched stem-cell-derived islet product generated using the company’s human pluripotent stem-cell platform. NewcelX describes the platform as capable of scalable expansion and controlled differentiation, with the broader objective of producing off-the-shelf allogeneic cell therapies.

Earlier this year, NewcelX and Eledon established a collaboration to develop NCEL-101 in combination with tegoprubart.

In July, NewcelX announced that it had completed a Type B pre-IND meeting with the FDA and received feedback supporting its proposed development pathway toward a first-in-human trial of the combination.

The strategy is notable because it attempts to combine two approaches that have independently accumulated supportive evidence: stem-cell-derived islets as a renewable source of insulin-producing cells and tegoprubart as an alternative immune-protection strategy.

It is still early. NCEL-101 has not yet produced clinical efficacy data in type 1 diabetes.

But if a stem-cell-derived product can reproduce the insulin independence seen with donor islets while using a more tolerable immune regimen, another major barrier to broader treatment could begin to fall.

Sana Is Trying to Remove Immunosuppression Entirely

Sana Biotechnology (NASDAQ: SANA) is taking a different route: engineer the transplanted cells so the immune system does not recognize them as foreign.

Its hypoimmune, or HIP, platform makes genetic modifications intended to allow transplanted cells to evade immune detection.

The company has already obtained an important early human signal.

In an investigator-sponsored study at Uppsala University Hospital, pancreatic islets modified with Sana’s HIP technology were transplanted into a patient with type 1 diabetes without immunosuppressive therapy.

At 14 months, the cells remained detectable and functional, producing C-peptide — evidence that the transplanted beta cells continued to secrete insulin. Sana reported no identified safety issues, and the follow-up findings were subsequently published in the New England Journal of Medicine.

There is an important distinction: this was a single patient, and the treatment has not yet demonstrated the broad insulin independence seen in larger islet-transplant studies.

But scientifically, the finding matters.

It provides early human evidence that genetically modified islet cells may survive and function for more than a year without systemic immunosuppression.

Sana is now translating that technology into SC451, a hypoimmune-modified, stem-cell-derived pancreatic islet therapy intended to combine an expandable cell source with the immune-evasion properties demonstrated by the earlier donor-derived cells. The company has been progressing toxicology, manufacturing transfer and clinical readiness activities toward a Phase 1/2 study.

If successful, that combination would attack both fundamental barriers simultaneously.

Century Is Designing Immune Evasion Into the Product

Century Therapeutics (NASDAQ: IPSC) is pursuing a similar objective through its iPSC platform.

Its lead diabetes program, CNTY-813, is an iPSC-derived islet replacement therapy incorporating Century’s Allo-Evasion technology, which is designed to help transplanted cells avoid immune rejection without requiring conventional immunosuppression.

At the American Diabetes Association’s 2026 Scientific Sessions, Century reported preclinical results showing durable glucose control for more than eight months in animal models, continued insulin secretion under allogeneic immune pressure and successful manufacturing at clinical scale.

Century completed a pre-IND meeting with the FDA and, as of August, remained on track for an IND submission in the fourth quarter of 2026. Initial clinical data are expected in the second half of 2027.

Like BetaNova’s SR-03 and Sana’s SC451, CNTY-813 represents the emerging second generation of the field: not merely replacing beta cells, but engineering the replacement cells around the immune system that destroyed them in the first place.

The Four Problems a Scalable Cure Has to Solve

Together, these programs show why the phrase “cure for type 1 diabetes” needs qualification.

Researchers increasingly use the term functional cure: restoring sufficient natural insulin production to achieve durable glucose control and potentially eliminate exogenous insulin, even though the underlying predisposition toward autoimmune disease may still exist.

The concept itself now has considerably more evidence behind it than it did only a few years ago.

What remains uncertain is whether it can become scalable.

Cell source. There must be enough high-quality insulin-producing cells to treat patients without relying on scarce donor pancreases.

Engraftment and durability. Those cells need an environment where they can receive a blood supply, sense glucose, and keep functioning for years.

Immune protection. The therapy must address both rejection of foreign cells and the autoimmune biology responsible for type 1 diabetes, ideally without requiring lifelong toxic immunosuppression.

Manufacturing. A commercial therapy ultimately must be reproducible, quality-controlled, and economical at a scale far larger than today’s transplantation programs.

Different companies are solving different portions of the equation.

Vertex has produced perhaps the strongest evidence yet that manufactured stem-cell-derived islets can restore insulin independence, but currently requires immunosuppression. Eledon’s results suggest immune modulation may make transplantation considerably more practical. Sana has shown early human evidence of immune-evasive islets functioning without immunosuppression. Century is building immune protection directly into a scalable iPSC-derived product. NewcelX is pairing stem-derived islets with Eledon’s immune-modulation approach.

And with the creation of BetaNova, Sernova and Seraxis are attempting to combine the cells, manufacturing, implantation environment, and immune strategy within a single company.

A Cure Is Not Here Yet — But the Question Has Changed

There are still substantial risks.

Several of the most ambitious programs remain preclinical or have only limited human data. Cell manufacturing is complex. Gene editing can introduce additional safety considerations. Immune-evasion technologies must demonstrate that modified cells remain safe and controllable over long periods. Devices must overcome issues including vascularization and fibrosis. And any therapy intended for otherwise healthy people living successfully with modern insulin technology will face a very high safety bar.

The field has already produced reminders of those challenges. Vertex discontinued development of its VX-264 encapsulated islet program in 2025 after the device approach failed to produce sufficient C-peptide responses, even though it was generally well tolerated.

That result illustrates how difficult it is to solve all of the biological problems at once.

But the larger trajectory is becoming harder to dismiss.

Donor islets have demonstrated that replacing the missing cells can eliminate insulin dependence. Stem-cell-derived islets have now demonstrated the ability to restore physiological insulin function in humans. Improved immunomodulation has produced insulin independence in a growing transplantation cohort. Immune-engineered islets have also survived in a human patient for more than a year without immunosuppressive drugs.

Meanwhile, multiple companies are preparing to move next-generation, scalable cell products into human trials over the coming year.

The question surrounding islet cell therapy is therefore shifting.

It is no longer simply whether transplanted cells can restore insulin production in type 1 diabetes.

Increasingly, the question is whether biotechnology can combine a renewable cell supply, reliable engraftment, and durable immune protection into a therapy that can be produced safely for thousands and eventually perhaps millions of patients. Today’s formation of BetaNova is another bet that the answer could ultimately be yes.

Release – Nutriband Receives USPTO Notice of Publication of Commercial Brand Name Trademarks for Its Abuse Deterrent Fentanyl Patch

Posted on by [email protected]

Research News and Market Data on NTRB

Tuesday, September 8, 2026 9:00 AM ET

 

Nutriband has received a Notice of Publication from the United States Patent and Trademark Office (USPTO) for commercial brand name trademarks for its lead product, an abuse deterrent fentanyl transdermal system.

Once allowed, Nutriband plans to submit its commercial worldwide brand name to the FDA and other international regulatory agencies for approval.

ORLANDO, Fla., Sept. 08, 2026 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has received a Notice of Publication from the United States Patent and Trademark Office (USPTO) dated September 2, 2026 for commercial brand name trademarks for its lead product, an abuse deterrent fentanyl transdermal system. Trademarks will be published in the USPTO Trademark Official Gazette. If no objections are filed during the 30-day opposition period, the USPTO is expected to issue a Notice of Allowance.

Nutriband intends to secure full intellectual property rights for its commercial brand names in the United States and internationally. The proposed brand name and product labeling will be submitted to the FDA and other international regulatory agencies for review and approval.

Nutriband’s fentanyl transdermal system is based on its AVERSA₢ abuse deterrent transdermal technology and has the potential to be the world’s first abuse-deterrent patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl.

Nutriband’s abuse deterrent fentanyl transdermal system has the potential to reach peak annual US sales of $80 million to $200 million. While initially concentrating on the US market, the unmet medical need for adequate pain management is a global problem, and the product is in development for all major medical markets worldwide.

Nutriband’s AVERSA₢ abuse-deterrent technology is utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The AVERSA₢ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

Health Advances Aversa Fentanyl market analysis report 2022

About AVERSA₢ Abuse-Deterrent Transdermal Technology

Nutriband’s AVERSA₢ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA₢ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

About Nutriband, Inc.

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

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

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Forms 10-K’s and Forms 10-Q’s, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Nutriband is a registered trademark of Nutriband, Inc. AVERSA is a trademark of Nutriband, Inc.

Brand Institute and Drug Safety Institute are registered trademarks of Brand Institute, Inc.

Contact Information:

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

SOURCE: Nutriband Inc.

Release – Clinical Trial for an Oral Drug to Treat Ebola is Registered in the Pan African Clinical Trials Database and is Ready to Go, As the Largest Ebola Outbreak Continues to Expand in DR Congo

Posted on by [email protected]

Research News and Market Data on NNVC

Tuesday, 08 September 2026 08:30 AM

SHELTON, CT / ACCESS Newswire / September 8, 2026 / 

The clinical trial is entitled with a descriptive title: “An adaptive, multi-centre Phase IIA/IIB clinical trial of NV-387 oral gummies plus optimised supportive care in adults with Ebola virus disease (Bundibugyo or other orthoebolaviruses): a single-arm safety and dose run-in (Phase IIA) followed by a randomised, controlled, open-label efficacy evaluation with independent blinded-endpoint adjudication (Phase IIB).” Prof. Patrick de Marie Chimusa Katoto is listed as the principal investigator to lead this clinical trial, as previously announced by the Company.

Under the leadership of Professor Katoto, NanoViricides, as the drug sponsor of NV-387 Oral Gummies, has received regulatory approval to begin this Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for the Current Bundibugyo Ebolavirus and other Ebola viruses, from the local regulatory agency ACOREP in the Democratic Republic of Congo (DRC).

The drug product, NV-387 Oral Gummies was shipped to and has been received at the clinical trial site in Ituru province last week.

Therefore, it is anticipated that the first Ebola patient dosing with NV-387 oral gummies under this clinical trial can be expected to occur within one to two weeks, barring impediments caused by the very ebola disease outbreak that the trial is designed to respond to.

“We now eagerly await the first dosing of Ebola patients with our NV-387 Oral Gummies drug product that is already available in the clinical trial site,” said Anil R. Diwan, PhD, President of the Company, adding, “We, our colleagues, and our partners are hoping that this orally available, unique and revolutionary broad-spectrum antiviral drug succeeds in combatting the Bundibugyo virus for which there is no known treatment or vaccine.”

The current Ebola Virus Disease (EVD) caused by the Bundibogyo ebolavirus (BDBV) is now the largest ever ebola outbreak, as well as the fastest growing ebola outbreak in DRC.

As of September 5, 2026, there have been 6,604 confirmed cases, and 3,175 deaths, in DRC alone, according to the CDC 1. In comparison, as of August 14, 2026, there were reported 4,945 confirmed cases and 2,325 confirmed deaths due to this virus. The crude fatality rate (crude CFR) 2 has further increased to 48% from 46% calculated as of August 14th. This Ebola outbreak is now the fastest growing ebola outbreak in the world. Additionally, it is also possibly the deadliest ebola outbreak. At this rate, the current outbreak is on track to exceed the worst ever ebola zaire outbreak in West Africa in 2014-2016 3. In that outbreak, 28,616 cases and 11,310 deaths were recorded across Guinea, Liberia and Sierra Leone, according to the World Health Organization.

Schools have reopened normally in the Ebola affected regions across DRC, despite the well understood risk of transmission in schools. Teaching and implementing hygienic measures such as use of hand sanitizers and frequent hand washing is expected to minimize risk, enabling the children to have in-class education. The alternative of remote learning is very difficult to implement in resource-poor environments, and risks the children’s education itself. If cases occur, schools would be shut down. The risk is high, particularly because the case fatality rate (CFR) in children is at 60%, much greater than the CFR for adults at sub-50% 4.

Additionally, health care workers (HCW) are at high risk, despite personal protective equipment, because of close contact with the patients. At least 43 HCWs have died from Ebola and at least 160 have contracted the disease 5.

The need for an oral drug to combat this disease is thus obvious. An oral drug to treat patients, to prevent contacts from contracting the disease, and to keep healthcare workers safe, is sorely needed to combat this outbreak. There is a tremendous urgency to validate a drug that works against this ebolavirus in short and decisive clinical trials for minimizing further spread by treating patients and for saving lives. Om Sai CRO, in consultation with renowned scientists in DRC, has designed the Phase II clinical trial with this particular objective.

“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 others that are infusions. Thus evaluating if NV-387 treatment works is of paramount importance to combat this and future Ebola and Marburg outbreaks.”

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, we believe an oral drug is a highly advantageous feature.

An oral drug called obeldesivir, which is related to the known drug remdesivir that previously failed in clinical trials against Ebola Zaire, is being tried in a clinical trial, but only as a preventative measure, and not as a treatment of active infection.

In contrast, in the PARTNERS clinical trial, infusions of antibody cocktails and of remdesivir are being tried. About 300 patients have been enrolled already (across 4 groups) in the PARTNERS trial, according to the WHO 6. This trial will require over 1,000 patients to be treated and may not yield results for several months. A similar large collaborative clinical trial effort in the West Africa 2014-2016 outbreak resulted in US FDA approval of two antibody drugs only specifically for EBOV Zaire, which are not deemed to be useful in the current outbreak without further clinical trials.

Three different vaccines are also expected to enter into clinical trials for efficacy within months, according to the WHO 7.

As of now, there is practically no risk from this Ebola outbreak for the USA, according to the CDC. The US has imposed strict travel restrictions to avoid any possible introduction of the ebola virus into the USA. The CDC is intimately involved in the Ebola response with 150 personnel deployed within DRC for the efforts (ibid #1).

NanoViricides has retained Om Sai Clinical Research Private Limited, India, (Om Sai CRO) as the CRO for this Phase II clinical trial for Ebola in DRC. Om Sai CRO has been instrumental in putting together the team with Prof. Katoto and other renowned experts and with support from the University of Bukavu and in the Ebola-affected region to lead and execute the clinical trial of NV-387 Oral Gummies as a Treatment for Ebola viruses in DRC.

As the Ebola outbreak continues to expand, several limitations on travel are being instated. There are also limitations on availability of resources such as PPE and diagnostic kits, which are compounded by the travel and other restrictions. These on-ground situations have caused delays in our efforts, and we anticipate such delays to continue due to the tenuous outbreak situation.

This Ebola outbreak continues to increase in spread and is now present in at least six provinces in DRC and threatening South Sudan 8. More concerning is the fact that over 80% of new cases are outside of known contact lists, leading to the projection that the extent of the outbreak is at least two times or more larger than the reported confirmed cases. Additionally, Ebola is now found to have spread into displacement camps that host over 4.4 million displaced persons due to internal warfare, adding another high risk population pool with poor drinking water, sanitation and medical resources to further fuel this outbreak, according to the UN New Service.

Treatments under consideration except for NV-387 which is orally available, require infusions. Infusions are difficult to implement and also are not scalable in a large outbreak scenario such as this Ebola virus outbreak if it continues to grow, as has been widely expected.

A clinical trial, called the “PARTNERS” clinical trial, evaluating Remdesivir infusion, an antibody cocktail MBP134 infusion, and MBP134 infusion plus Remdesivir infusion, has started according to WHO with first patient having received infusion of the antibody cocktail on July 2, 2026 9.

“Although this antiviral (Remdesivir) proved to be ineffective at targeting the Zaire Ebolavirus, there remains hope that it could have some benefit against the Bundibugyo virus, particularly if used in combination with MBP-134,” according to an article in Forbes explaining the “PARTNERS” clinical trial by the WHO organized collaboration 10. The article also notes that MBP134 contains two separate antibodies designed to, taken together, recognize multiple Ebola species.

Antibodies are highly specific to a particular strain of the virus and usually are not very effective against variants of the same virus that arise in the field. Viruses also escape antibodies readily by mutations in the field.

The Company notes that 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 reasonably expected to extend to the current novel Bundibugyo ebolavirus strain.

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 DRC. The rare Bundibugyo strain of Ebola virus causing the current outbreak appears to be its new variant, likely freshly introduced from some animal source 11, such as fruit bats.

Clinical trials of an Oxford University designed Bundibugyo-specific vaccine, and a Moderna mRNA-based vaccine have started for determining safety in humans (Phase I) outside DRC, to be followed by efficacy trials in DRC. Further, Ervebo, a vaccine approved for Ebolavirus Zaire, may also enter clinical trials for the protection of uninfected persons from the distinctly different Bundibugyo ebolavirus due to the enormity of the emergency posed by the current outbreak despite reservations regarding a potentially imperfect vaccine 12.

Om Sai is the CRO leading the Company’s Phase II clinical trial of NV-387 Oral Gummies as a Treatment for Mpox in DRC, and the same CRO is also leading the newly approved Ebola clinical trial.

Sufficient quantity of NV-387 Oral Gummies Drug Product for starting the clinical trial against Ebola is already available now at the clinical trial site in Ituri, DRC. This drug product was shipped to DRC for the ensuing Phase II clinical trial of NV-387 for the Treatment of Mpox and also to support the Phase II clinical trial for the Treatment of Ebola.

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 host-side 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.

“Only safe and effective broad-spectrum antiviral drugs like NV-387 that can effectively tackle 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, “Today, NV-387 is the only drug in clinical development with such broad-spectrum potential that promises to combat diverse epidemics like Mpox and Ebola, to the best of our knowledge.”

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 within just three months, rivaling the largest outbreak to date in 2014-2016 13. Unfortunately, the outbreak appears to be even more aggressive than the CDC model, with over 2,000 deaths in less than three months, over 4,000 confirmed cases, and over 10,000 estimated total cases 14.

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 15.

NV-387 is a broad-spectrum antiviral that mimics the host-side feature called heparan sulfate proteoglycan (HSPG) 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 prior to gaining entry into the cell. Thereafter, followed by entry into the cell inside endosomes, the ebolavirus surface glycoprotein is substantially degraded, opening up its site for binding to its cognate receptor called NPC1, thereby entering into 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.

All previous anti-Ebola efforts have been focused on vaccines and antibodies 16. This has led to approval of therapies that are specific to the Ebolavirus 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.

In contrast, 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 and possibly all filoviruses; that would be a game changer for pandemic preparedness.

The case fatality rate of ebolaviruses has generally been approximately 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.

At present, BDBV has been consistently demonstrating crude CFR exceeding 46% in DRC. Therefore, BDBV is of great concern as a potential pandemic disease. However, it is believed that ebolaviruses do not transmit via respiratory droplets or aerosols and rather require extensive contact with bodily fluids of an infected person. In addition, within DRC and internationally, certain protective quarantine measures for travel from the outbreak areas have been implemented.

Therefore, currently there is no apparent threat of a global pandemic.

An irony is that because of the high case fatality rate (CFR) approaching 50%, the spread of ebolaviruses 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.

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.

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, with pre-travel quarantine requirements imposed, and suspect travelers are directed to screening at specific airports and may be further quarantined.

Travelers going to and from Central Africa need to constantly check travel restrictions as well as travel limitations in light of these changing outbreak conditions.

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:

1 https://www.cdc.gov/ebola/situation-summary/index.html

2 The Crude CFR is calculated simply by dividing the confirmed deaths by the confirmed number of cases on the same reporting date. It ignores the fact that the deaths are actually occurring in patients that were confirmed infected several days earlier; i.e. the time lag of sickness is not accounted for in the crude CFR. If it is accounted for, the actual fatality rate per confirmed infection (Infected Fatality Rate or IFR) would be much higher than the crude CFR. For example, if one assumes an average time lag of 21 days (Aug 14 to Sept 5), then the IFR on September 5 would be (3,175/4,945 = ) 64%. Not all infections are reported or confirmed by lab tests; however, it is likely that most deaths are counted. This produces a large uncertainty in such CFR and IFR estimates.

3 https://www.telegraph.co.uk/global-health/science-and-disease/ebola-outbreak-doubling-every-20-days-warns-un-chief/

4 https://www.news4jax.com/news/world/2026/09/01/schools-resume-classes-in-congos-ebola-epicenter-despite-concerns-from-parents-and-teachers/ .

5 https://www.ft.com/content/abd30cb8-08f6-4a1a-a92b-f1fcc339ea82?syn-25a6b1a6=1&signupConfirmation=success

6 https://d2233.cms.socastsrm.com/2026/09/02/whos-tedros-says-ebola-response-must-be-scaled-up-to-tackle-congo-outbreak/

7 https://www.yahoo.com/news/science/articles/congo-ebola-outbreak-slows-epicentre-050000953.html

8 https://www.aljazeera.com/news/2026/7/20/ebola-death-toll-in-drc-surges-to-at-least-930-as-outbreak-gathers-pace

https://www.aljazeera.com/news/2026/7/16/ebola-spreading-more-quickly-in-drc-while-uganda-is-close-to-being-virus-free

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

10 https://www.forbes.com/sites/omerawan/2026/07/07/new-clinical-trials-offer-hope-in-the-fight-against-ebola-in-the-democratic-republic-of-congo/

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

12 https://www.msn.com/en-us/health/general/ebola-cases-top-4-000-in-drc-as-who-urges-ervebo-vaccine-trial/ar-AA29CX9f?ocid=BingNewsSerp .

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

14 The WHO and Africa CDC have estimated that the confirmed case number substantially under-represents actual case numbers which could be at least double or even more than confirmed cases. See #5.

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

16 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

Eledon Pharmaceuticals (ELDN) – Clinical Milestones For Tegoprubart Trials In 2H26 Reiterated

Posted on by [email protected]


Friday, September 04, 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.

Eledon Reiterated Plans For Tegoprubart Trials In Kidney Transplantation and Diabetes. Eledon has confirmed plans to initiate its Phase 3 LEGACY trial, testing tegoprubart to prevent rejection after kidney transplants. The trial will have two arms, comparing an immuno- suppressive regimen with tegoprubart to a regimen with tacrolimus. Each arm has a target enrollment of about 300 patients at clinical sites worldwide. The primary endpoint will be a composite of BRAR, graft loss, and death. Secondary endpoints include measures of kidney function and side effects associated with tacrolimus.

IND For Islet Cell Transplantation In Diabetes Has Been Filed. The company has submitted an IND (Investigational New Drug) application to begin testing tegoprubart to prevent rejection of islet cell allograft transplants in type 1 diabetes (T1D). To date, 12 patients treated in the first trial have achieved cell engraftment and normalized blood glucose. Their recent HbA1c levels averaged 5.4%, comfortably below the standard 6.5% threshold for diabetes. The upcoming trial will be multicenter and intended to meet requirements for FDA approval.


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Release – Eledon Pharmaceuticals Announces Islet Cell Transplantation IND Submission, First Patients Enrolled in Multiple Transplant Programs, and Reaffirms Plan to Initiate Phase 3 Kidney Transplantation Trial in Fourth Quarter 2026

Posted on by [email protected]
eledon logo

Research News and Market Data on ELDN

September 3, 2026

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IND submitted to FDA for Eledon-sponsored, registrational study of tegoprubart in islet cell transplantation for patients with type 1 diabetes

First patients enrolled in new investigator-initiated study of tegoprubart in patients with renal dysfunction receiving an islet cell transplant

First patient dosed under compassionate use of tegoprubart for conversion from tacrolimus in islet cell transplant recipients with calcineurin inhibitor related kidney dysfunction

First patients dosed under compassionate use of tegoprubart in highly sensitized patients with pre-existing antibodies receiving a kidney transplant

Company on track to initiate global Phase 3 LEGACY trial of tegoprubart in kidney transplantation in Q4 2026

IRVINE, Calif., Sept. 03, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced significant progress across multiple tegoprubart development programs in kidney allotransplantation and islet cell transplantation. The Company also reaffirmed that it remains on track to initiate LEGACY, its global Phase 3 clinical trial evaluating its investigational novel immunosuppression therapy tegoprubart, an anti-CD40L antibody, in patients undergoing kidney transplantation, in the fourth quarter of 2026.

“The progress announced today reflects the growing breadth and momentum of tegoprubart’s clinical development across multiple transplant settings as we work to redefine transplant immunomodulation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We remain on track to initiate our global Phase 3 LEGACY trial in kidney transplantation in the fourth quarter of 2026, while the submission of an IND for our first Company-sponsored islet cell transplantation study represents an important regulatory milestone for the tegoprubart program. In parallel, investigator-initiated studies and compassionate-use experience are expanding the clinical evaluation of tegoprubart into transplant populations with significant unmet needs, including in patients experiencing calcineurin inhibitor-related toxicities and in highly sensitized kidney transplant recipients who face elevated immunologic risk. These new programs are expected to generate important clinical insights and data updates over the next 12 months.”

Islet Cell Transplantation

  • IND submitted for Eledon-sponsored islet cell transplantation study in type 1 diabetes. Eledon has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a planned Company-sponsored, registrational clinical trial evaluating tegoprubart for the prevention of allograft rejection in type 1 diabetes (T1D) patients undergoing pancreatic islet cell transplantation. The planned study would be Eledon’s first Company-sponsored clinical trial in islet cell transplantation and represents an important step in the Company’s registrational pathway for tegoprubart in this patient population.
  • First patients enrolled in a new investigator-initiated study involving islet cell transplant recipients with T1D and chronic kidney disease. The first patients have been enrolled in an investigator-initiated clinical trial evaluating tegoprubart for the prevention of allograft rejection in patients with T1D and renal dysfunction from chronic kidney disease receiving an islet cell transplant. The study, underway at the University of Chicago Medicine Transplant Institute, evaluates a calcineurin inhibitor–free, tegoprubart-based immunosuppression regimen in patients who are especially susceptible to tacrolimus toxicity, including kidney damage, which has long constrained the use of islet cell transplantation.
  • First islet cell transplant recipient dosed with tegoprubart following conversion from tacrolimus. The first islet cell transplant recipient has been dosed with tegoprubart under a compassionate-use protocol allowing them to switch from their previous tacrolimus-based immunosuppression therapy due to calcineurin inhibitor–related renal dysfunction. This compassionate use of tegoprubart may address an important unmet need among transplant recipients who require lifelong immunosuppression therapy to preserve graft function but experience renal complications often associated with calcineurin inhibitors such as tacrolimus, today’s standard of care.
  • Ongoing UChicago Medicine investigator-initiated study in participants with T1D undergoing islet cell transplantation expanded by three patients. UChicago Medicine is adding three additional patients in its ongoing investigator-initiated islet cell transplantation study evaluating tegoprubart as the core immunosuppressant, expanding the study beyond the 12 patients treated to date. This enrollment expansion builds on previously reported results in which all 12 patients with T1D achieved insulin independence, producing their own insulin and no longer requiring exogenous insulin therapy to manage their disease, and a hemoglobin A1c (HbA1c) level below 7.0% following islet cell transplantation and treatment with tegoprubart. Stable islet graft function was observed across all 12 study participants through a maximum reported follow-up of 22 months. Tegoprubart demonstrated a favorable tolerability profile, with no evidence of nephrotoxicity, hypertension, or neurotoxicity, which are side effects often associated with calcineurin inhibitors such as tacrolimus.

Kidney Transplantation

  • Phase 3 LEGACY clinical trial on track to initiate in Q4 2026. Following its successful End-of-Phase 2 meeting with the FDA, Eledon remains on track to initiate its global Phase 3 trial of tegoprubart in kidney transplantation (LEGACY) in the fourth quarter of 2026. The LEGACY trial is expected to enroll approximately 600 patients, with a primary endpoint of non-inferiority versus tacrolimus at 52 weeks based on a composite of biopsy-proven acute rejection (BPAR), graft loss, and death.
  • First highly sensitized kidney transplant patient dosed under compassionate use. The first highly sensitized kidney transplant patient has been dosed with tegoprubart under a compassionate-use protocol at Duke University Medical Center. Highly sensitized patients requiring a kidney transplant face a substantial unmet need because pre-existing antibodies can significantly limit access to compatible donor organs and increase the risk of antibody-mediated rejection and graft loss post-transplant. The compassionate use of tegoprubart in this setting will help expand our clinical insights and understanding of tegoprubart’s potential in a particularly challenging patient population.
  • Third patient treated in investigator-initiated kidney transplant tolerance study. A third patient has been treated in the investigator-initiated study evaluating tegoprubart for kidney transplant tolerance induction at Massachusetts General Hospital (MGH). Tolerance induction has the potential to eliminate the need for patients to require lifelong immunosuppression therapy.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40L biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Specifically, our ability to achieve our anticipated future development and corporate milestones depends on our ability to obtain additional financing on acceptable terms. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: our short operating history and shifts in our business strategy; our operating losses since inception; our need for additional funding to develop our lead drug candidate and our ability to secure additional funding on acceptable terms or at all; the impact of issuances of our common stock, including the possibility of dilution or a decline in our stock price; our ability to successfully develop our product candidates; unfavorable global economic and financial market conditions; the regulatory environment of our business and our ability to obtain required regulatory approvals; results of non-clinical studies and clinical trials, and risks that non-clinical studies or early clinical trials may not be predictive of results of later-stage clinical trials; delays or difficulties in enrollment of patients in clinical trials; our ability to attract and retain our executives and key employees; legislation of the pharmaceutical and healthcare industries; cybersecurity and data privacy risks; the ability of our products to achieve marketing approval; competition in our industry; our ability to obtain insurance coverage; our dependence on contract research organizations; our ability to protect our intellectual property; public health crises; our ability to maintain proper and effective internal control over financial reporting and other risks disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 19, 2026. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ materially from the forward-looking statements contained herein, are discussed in our Annual Report on Form 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not as of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

Eli Lilly Pays Up to $2.9 Billion for a Biotech That Deletes the Antibodies Making People Sick

Posted on by [email protected]

Eli Lilly (NYSE: LLY) announced Monday it has agreed to acquire privately held Merida Biosciences in an all-cash deal worth up to $2.875 billion, adding a genuinely distinct approach to autoimmune and allergic disease treatment to its growing immunology pipeline. The transaction includes an upfront cash payment plus additional milestone payments tied to future development and regulatory progress, though Lilly has not disclosed the specific breakdown between the two. The deal is expected to close in the fourth quarter of 2026, subject to regulatory approval.

What makes Merida’s science genuinely interesting is the mechanism itself. Most existing treatments for autoimmune conditions work by broadly suppressing the immune system, which can control symptoms but often leaves patients more vulnerable to infection and other side effects. Merida is developing biologics engineered to do something more precise, selectively identifying and eliminating the specific malfunctioning antibodies, known as autoantibodies, that are actually causing a given disease, while leaving the rest of the immune system intact.

That broader shift toward precision, antibody-targeted immunology is playing out across the sector, not just at Lilly. Smaller clinical-stage companies like Eledon Pharmaceuticals are pursuing a related but distinct approach, targeting the CD40L signaling pathway that drives the immune system’s production of pathogenic antibodies in the first place, rather than eliminating those antibodies after they’ve formed. Eledon’s lead candidate is currently in development for organ transplant rejection and other immune-mediated conditions, illustrating how the industry is converging on more targeted immune intervention from multiple different angles simultaneously.

The company’s lead program, MER511, is currently in Phase 1 development for Graves’ disease and thyroid eye disease, two related conditions caused by autoantibodies that overactivate the thyroid-stimulating hormone receptor. Graves’ disease affects an estimated 3 million people in the United States alone, causing an overactive thyroid, while thyroid eye disease can lead to inflammation, eye bulging, double vision, and in severe cases, permanent vision impairment. Early data has reportedly shown the drug substantially lowering the specific antibodies driving both conditions, alongside a favorable initial safety profile.

Beyond its lead asset, Merida’s pipeline includes MER769, an earlier-stage program targeting the antibody responsible for food allergy, asthma, and chronic spontaneous urticaria, along with additional early research in kidney conditions such as membranous nephropathy. That breadth is part of the appeal for Lilly, since a single validated approach to eliminating disease-causing antibodies could theoretically be applied across a range of otherwise unrelated conditions, giving the acquisition multiple potential paths to commercial value rather than resting on one single drug candidate.

This acquisition continues a pattern that has defined Lilly’s strategy through much of 2026. Flush with cash from the success of its weight-loss and diabetes franchise, the company has been unusually active on the acquisition front this year, using that financial strength to diversify its pipeline well beyond obesity and metabolic disease and into other high-value therapeutic categories, immunology chief among them.

For investors tracking the small and microcap biotech space, this deal reinforces a theme that has run through nearly every major pharma acquisition this year. Large, well-capitalized companies continue to pay significant premiums for clinical-stage biotechs with a genuinely differentiated mechanism of action, even when that science is still in early-stage trials with no approved product or meaningful revenue yet. What matters most to these acquirers is a validated, novel approach to a disease category with real unmet need, precisely what Merida’s precision antibody-elimination platform represents here. That pattern is worth watching closely, since it continues to set the valuation benchmark for smaller, independent biotechs pursuing similarly differentiated science across immunology and beyond.

Release – Ocugen Announces First Patient Dosed in Phase 3 Registrational Trial of OCU410 Modifier Gene Therapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Posted on by [email protected]

Research News and Market Data on OCGN

September 1, 2026

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  • The single global Phase 3 trial, ArMaDa3 (NCT07770828), is the first pivotal gene therapy trial in geographic atrophy (GA)
  • U.S. Food and Drug Administration (FDA) granted OCU410 Regenerative Medicine Advanced Therapy (RMAT) designation, providing enhanced agency engagement throughout development and eligibility for accelerated approval and priority review
  • Phase 3 design fully aligned with FDA; Biologics License Application (BLA) filing anticipated in 2028
  • OCU410 is designed as a one-time subretinal gene therapy that addresses multiple disease pathways, offering a differentiated approach from approved complement inhibitors in the U.S. which address individual disease pathways and require ongoing intravitreal injections

MALVERN, Pa., Sept. 01, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the first patient was dosed in the global Phase 3 registrational trial of OCU410 (AAV5-hRORA), its first-in-class modifier gene therapy candidate for GA secondary to dry age-related macular degeneration (dAMD). The Company also highlighted the recent FDA RMAT designation for OCU410, which supports a potential accelerated development and review pathway for the program.

“Dosing the first patient in our global Phase 3 trial, just weeks after receiving RMAT designation, marks a defining moment for the OCU410 program – and for the millions of people living with geographic atrophy. Outside the U.S., there are currently no approved treatments for GA, while in the U.S., available treatment options address only one of the four disease pathways and require ongoing, repeated eye injections,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “This is our third modifier gene therapy program to advance into late-stage development, demonstrating the strength of our platform and our vision for potentially delivering a one-time treatment for life.”

The initiation of dosing follows the successful completion of a Type B End-of-Phase 2 (EOP2) meeting with FDA’s Center for Biologics Evaluation and Research (CBER) in July 2026, resulting in alignment on all critical Phase 3 design elements, including primary and secondary endpoints, dose, adaptive design, and a single pivotal trial pathway to support a BLA.

“We are entering a global single Phase 3 with a well-defined program: a dose validated in a randomized, controlled Phase 2 study; an FDA-endorsed primary endpoint measuring the rate of lesion growth; and a secondary endpoint assessing functional vision,” said Mohamed Genead, MD, Chief Medical Officer of Ocugen. “The Phase 3 program builds on compelling 12-month Phase 2 data, which demonstrated a statistically significant 31% reduction in lesion growth with the optimal dose compared with control following a single subretinal injection, along with concordant preservation of the ellipsoid zone and no drug-related serious adverse events (SAEs) or adverse events of special interest (AESIs).”

OCU410 delivers the human retinoid-related orphan receptor alpha (RORA) modifier gene via a single subretinal injection of an AAV5 vector. Unlike therapies targeting a single pathway, OCU410 is designed to simultaneously address multiple pathophysiological drivers of GA-complement overactivation, chronic inflammation, oxidative stress, and lipid dysregulation. GA affects approximately 2–3 million people in the U.S. and Europe and is a leading cause of irreversible central vision loss in older adults, with prevalence expected to rise as the population ages.

According to study investigator Victor Gonzalez, MD, “Patients with geographic atrophy continue to face irreversible structural and functional loss of the retina, along with limited treatment options. The OCU410 Phase 3 study provides an important opportunity to evaluate a novel, potential one-time gene therapy approach that could lessen the burden of current treatments in the U.S., which require patients to undergo multiple injections every year.”

Global Phase 3 Registrational Trial Design
The Phase 3 trial is a global, multicenter, randomized, controlled study enrolling 237 subjects with GA secondary to dAMD, randomized 2:1 to a single 200 µL subretinal injection of OCU410 (5×1010 vg/mL) or an untreated control arm, with sites in the United States, Canada, Europe, and Latin America.

  • Primary endpoint: Rate of change of square root-transformed GA lesion area (√mm²/year) by fundus autofluorescence (FAF) at baseline, Month 4, Month 8, and Month 12, analyzed by MMRM.
  • Secondary endpoints: Proportion of subjects with Low-Luminance Visual Acuity (LLVA) loss ≥15 ETDRS letters at two consecutive visits through Month 12, providing a functional vision anchor to the primary anatomic endpoint; and rate of change of ellipsoid zone (EZ) area loss by SD-OCT.
  • Regulatory path: A single, adequate and well-controlled Phase 3 trial, aligned with FDA feedback, is intended to support a BLA filing anticipated in 2028. Discussions are ongoing with the European Medicines Agency (EMA) regarding alignment to potentially support a marketing authorization application (MAA) in Europe with this single Phase 3 trial.

RMAT Designation: Regulatory and Strategic Significance
On July 29, 2026, FDA granted RMAT designation to OCU410 based on Phase 2 clinical data demonstrating clinically meaningful efficacy and a favorable safety profile, with no serious adverse events related to OCU410 reported. RMAT designation is granted to regenerative medicine therapies intended to treat serious or life-threatening conditions where preliminary clinical evidence indicates the potential to address an unmet medical need.

For the OCU410 program, RMAT designation provides:

  • Eligibility for accelerated approval and priority review, which may compress the time from BLA submission to potential market entry.
  • All benefits of Breakthrough Therapy designation, including intensive FDA guidance on efficient development and organizational commitment involving senior FDA leadership.
  • Early and frequent FDA interactions on the use of surrogate and intermediate clinical endpoints reasonably likely to predict long-term clinical benefit-directly relevant to OCU410’s FAF-based anatomic primary endpoint.
  • Potential flexibility in satisfying post-approval requirements, including through expanded patient registries or real-world evidence.

Taken together with FDA alignment on the Phase 3 design and the initiation of dosing, RMAT designation further de-risks the regulatory pathway for OCU410 and reinforces the differentiation of a one-time, multi-pathway gene therapy in a GA market currently served only by chronically administered intravitreal complement inhibitors.

Supporting Phase 2 ArMaDa Data
The Phase 3 trial and the RMAT designation are supported by 12-month data from the Phase 2 ArMaDa trial (NCT06018558), a multicenter, randomized, controlled study of 51 subjects with GA secondary to dAMD.

  • Lesion growth (FAF): 31% reduction in GA lesion area growth rate in the medium dose group versus control at 12 months (p < 0.05) in the pivotal phase 3 population (lesion size of ≥2.5 mm2 and ≤17.5 mm2), a potential 2× treatment benefit relative to the 15% and 22% reductions reported for currently approved therapies in the U.S. at 12 and 24 months, respectively.
  • EZ preservation (SD-OCT): 27% reduction in ellipsoid zone area loss in the medium dose group versus control, a structural correlate of visual function.
  • Responder analysis: In the medium dose group, approximately 20% of treated subjects showed no disease progression; 75% demonstrated >30% reduction in lesion growth at 12 months.
  • Safety: No OCU410-related serious adverse events (SAEs) or adverse events of special interest (AESIs) reported to date.

About OCU410
OCU410 (AAV5-hRORA) is Ocugen’s investigational first-in-class modifier gene therapy, delivering the RORA gene via a single unilateral subretinal injection to regulate complement activation, neuroinflammation, oxidative stress, and lipid metabolism – multiple pathways implicated in the pathogenesis of GA. OCU410 has received RMAT designation from the FDA and Advanced Therapy Medicinal Product classification from the European Medicines Agency’s Committee for Advanced Therapies.

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

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

Contacts
Investors:
Candice Masse
astr partners
[email protected]

Media:
Chris Clark
[email protected]

Cadrenal Therapeutics (CVKD) – Alignment Reached With FDA On Phase 3 Design For CAD-1005 in HIT

Posted on by [email protected]


Tuesday, September 01, 2026

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

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

Phase 3 Design Can Move Forward With Expected Endpoints. Cadrenal announced that it held a Type D meeting with the FDA and has reached agreement on the design of the Phase 3 trial to test CAD-1005 in HIT (heparin-induced thrombocytopenia). This includes the primary endpoint, the protocol, and the statistical analysis plan (SAP). We see this as a significant step for the product and for the company’s plan to pursue collaboration to develop CAD-1005.

Primary and Secondary Endpoints Have Been Defined. The primary endpoint will be worsening HIT, defined as progression of thrombotic events through treatment day 14 or hospital discharge. A composite score composed of several aspects of thrombotic events will be used to measure progression. These include extension of an existing thrombus and the proportion of Serotonin Release Assay-positive (SRA+) patients with worsening composite thromboembolic events (CTEs) through Day 14 or hospital discharge.


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Release – NeuroSense Unveils Accelerated, Capital-Efficient Strategy to Advance PrimeC Toward Potential Approval in ALS

Posted on by [email protected]

Research News and Market Data on NRSN

Three-part program – AI-enabled characterization of PrimeC’s formulation advantage, an active-comparator trial against edaravone, and a streamlined pivotal pathway – is designed to strengthen PrimeC’s differentiation, shorten the time to potential commercialization, and significantly reduce overall development costs, complemented by a parallel regulatory pathway in Canada.

CAMBRIDGE, Mass., Aug. 31, 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 a redesigned development plan for PrimeC in amyotrophic lateral sclerosis, structured to reach a potential path for regulatory submission and approval faster and at materially lower cost than the Company’s previously planned development path.

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ALS drug development has been shaped by a single model: large, long, expensive confirmatory trials that few companies can fund and that people with ALS wait years to read out. NeuroSense’s plan replaces that single large commitment with three shorter, focused studies, each designed to answer a specific question that regulators, physicians, partners or payers routinely ask.

The redesigned strategy builds on the totality of evidence generated in NeuroSense’s Phase 2b PARADIGM study, including clinically meaningful effects on functional decline, statistically significant modulation of extracellular vesicle-associated TDP-43, consistent findings across multiple disease-related biomarkers, and encouraging long-term survival results. NeuroSense has already received FDA clearance to initiate its pivotal Phase 3 PARAGON trial. Together, these clinical, biomarker and regulatory advances provide the foundation for a more focused and capital-efficient development pathway.

AI-enabled characterization of PrimeC’s formulation advantage. PrimeC is an extended-release fixed-dose combination engineered to synchronize the pharmacokinetic profiles of its two active components. In a completed clinical pharmacokinetic study, PrimeC produced a synchronized exposure profile that was not reproduced when the individual components were administered together. NeuroSense is now applying AI-enabled modeling to these clinical data to quantify the magnitude of that difference, assess its consistency across individual patients and further characterize the contribution of PrimeC’s proprietary formulation. This work builds upon PrimeC’s established intellectual property position and is intended to support potential additional patent protection while providing clinicians, payers and prospective partners with an objective basis for distinguishing PrimeC from any co-administration of its individual components.

A direct comparative study against edaravone. NeuroSense plans to conduct an active-comparator clinical study designed to evaluate PrimeC directly against edaravone, an established ALS therapy. Head-to-head trials are not common in ALS, and differentiated results could provide people with ALS, clinicians, payers and prospective partners with compelling evidence of PrimeC’s relative clinical value and commercial potential.

A streamlined pivotal pathway. NeuroSense is evaluating an optimized design for its planned Phase 3 study (PARAGON) that would be substantially smaller and shorter in duration than previously planned, enriched for participants earlier in their disease course and intended to support an earlier regulatory submission. Any such pivotal design remains subject to alignment with FDA. The Company plans to discuss with the FDA whether its existing data may support full approval or, alternatively, an Accelerated Approval pathway, with an additional study conducted post-approval as required.

A parallel path to earlier access in Canada. NeuroSense has completed the pre-New Drug Submission process with Health Canada and is preparing a New Drug Submission for PrimeC, which the Company continues to target for December 2026. If accepted and ultimately approved, this pathway has the potential to make PrimeC available to Canadian patients on the strength of data already generated.

“One of the hardest constraints in ALS is not scientific – it is that the standard development path takes longer than patients have,” said Alon Ben-Noon, Co-Founder and Chief Executive Officer of NeuroSense. “We have asked a straightforward question: what is the shortest reasonable route from the data we already hold to a therapy people can actually receive? This plan is our answer. It is faster, it costs less, and it produces a stronger package – pharmacology, comparative clinical context, and a pivotal dataset – than the single-trial approach would have.”

About NeuroSense

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

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

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

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

About PrimeC

PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to target several key mechanisms that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation, with the potential to inhibit disease progression.

About ALS

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

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the potential benefits of the Company’s redesigned development strategy for PrimeC. Further, certain forward-looking statements, including statements regarding the potential regulatory pathways for 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 potential for delay in the timing of the Phase 3 clinical trial (PARAGON) in ALS; potential delay in the Canadian New Drug Submission; the risk that the Company will not be able to obtain financing on acceptable terms, or at all; the risk that the Company will not regain and maintain compliance with the Nasdaq listing requirements; the risk that the strategic opportunities described will not materialize or result in the anticipated benefits to the Company; uncertainty regarding outcomes and the timing of current and future clinical trials; the risk that PrimeC will not advance towards later-stage development; timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2026 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

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

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

SOURCE NeuroSense

For further information: Investor Relations: Or Eisenberg, Email: [email protected], Tel: +1315517554134