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Release – Tonix Pharmaceuticals Announces First Participant Dosed in Phase 1 Investigator-Initiated Pharmacodynamic Study of TNX-1900 (Intranasal Potentiated Oxytocin) to Assess Potential for Treating Migraine and Craniofacial Pain

Posted on March 26, 2026March 26, 2026 by aweinsoff@channelchek.com

March 26, 2026 7:00am EDT Download as PDF

Intranasal oxytocin blocks the release of calcitonin gene-related peptide (CGRP) in animal models and is the core technology of TNX-1900 for craniofacial pain conditions, including migraine and trigeminal neuralgia

TNX-1900 will be studied in the trigeminal neurovascular reactivity model, by measuring the forehead skin blood flow response to capsaicin and electrical stimulation by Laser Speckle Contrast Imaging (LSCI)

Oxytocin treatment affects a pathway distinct from the recently available CGRP migraine treatment drug class

BERKELEY HEIGHTS, N.J., March 26, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully integrated, commercial biotechnology company, today announced that the first participant has been dosed in a Phase 1 investigator-initiated study to evaluate the effect of TNX-1900 (intranasal potentiated oxytocin) on trigeminal nerve-mediated vasodilation of the forehead using capsaicin as well as electrical stimulation, a model for trigeminal neurovascular reactivity, in healthy female human volunteers. Dr. Antoinette Maassen van den Brink, Professor of Neurovascular Pharmacology, Erasmus University Medical Center, is serving as principal investigator and sponsor for the study in a collaborative research agreement with Tonix.

In animal studies, intranasal oxytocin has been shown to bind to oxytocin receptors in the trigeminal ganglion, blocking the release of calcitonin gene-related peptide (CGRP), a potent vasodilator critically involved in the pathogenesis of migraine.¹ Dr. Maassen van den Brink has previously found a CGRP inhibitor and a triptan to inhibit the forehead dermal blood flow response to capsaicin in migraineurs and healthy volunteers, respectively.^2,3

“We are excited to collaborate with Professor Maassen van den Brink on this proof-of-concept study investigating the potential for TNX-1900 for treating migraine, craniofacial pain, and other related conditions,” said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals. “While there are several CGRP inhibitors approved for the treatment of migraine, TNX-1900’s oxytocin treatment affects a distinct pathway that could address unmet needs. The results of the new study will guide future development of this potential non-opioid treatment for migraine and other craniofacial pain conditions.”

As part of the preliminary work in support of this study, Dr. Maassen van den Brink’s team recently validated a newer detection method for dermal blood flow known as Laser Speckle Contrast Imaging (LSCI) in the trigeminal neurovascular reactivity model.⁴

“We are excited to be using LSCI in this study of TNX-1900, which adds to our established model by providing real-time and higher resolution dermal blood flow measurements, compared to Laser Doppler Perfusion Imaging used in earlier studies,” said Dr. Maassen van den Brink. “Oxytocin represents a potential new therapeutic option, targeting a pathway in migraine and craniofacial pain that is distinct from both the triptan and CGRP inhibitor migraine treatment drug classes.”

About Migraine

Migraine is a neurovascular condition that typically manifests in a throbbing moderate to severe headache which lasts at least four hours, often on one side of the head and aggravated by routine physical activity. It can also be accompanied by nausea, vomiting, visual disturbances, and sensitivity to bright light and loud noises.⁵ Epidemiological studies indicate that globally, approximately 1.2 billion individuals suffer from migraines annually.⁶ In the U.S., approximately 39 million Americans suffer from migraines, and among these individuals, approximately four million experience chronic migraines (15 or more headache days per month, at least eight of which are migraines).⁶

About TNX-1900

TNX-1900 (intranasal potentiated oxytocin) is a proprietary formulation of oxytocin in development as a candidate for the treatment of migraine and craniofacial pain. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Oxytocin is a naturally occurring human peptide hormone that also acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential. Oxytocin when delivered via the nasal route, concentrates in the trigeminal system⁷ resulting in binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting the release of CGRP and transmission of pain signals returning from the site of CGRP release.¹ Blocking CGRP release is a distinct mechanism compared with CGRP receptor antagonist and anti-CGRP antibody drugs, which block the binding of CGRP to its receptor, or bind to the peptide CGRP. The addition of magnesium to the oxytocin formulation in TNX-1900 enhances oxytocin receptor binding⁸ as well as having an inhibitory effect on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models.⁹ Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children.¹⁰ Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects, which could potentially occur with systemic CGRP receptor antagonists and anti-CGRP (receptor) antibodies.¹¹ For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. The Company believes nasally targeted delivery of oxytocin could translate into selective blockade of CGRP release from neurons in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition. This mechanism is being investigated in a Phase 1 study to evaluate the effect of TNX-1900 on trigeminal nerve-mediated vasodilation of the forehead model for craniofacial pain. In addition, daily dosing is more rapidly reversible, in contrast to monthly or quarterly dosing, as is the case with anti-CGRP antibodies, giving physicians and their patients greater control. In addition to craniofacial pain conditions, TNX-1900 is being developed for treatment of binge eating disorder, adolescent obesity, bone health in pediatric autism and arginine-vasopressin deficiency. Tonix also has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions.

Citations

¹Tzabazis A, et al. Oxytocin receptor: Expression in the trigeminal nociceptive system and potential role in the treatment of headache disorders. Cephalalgia. 2016. 36(10):943-50.
²de Vries Lentsch S, et al. CGRP-mediated trigeminovascular reactivity in migraine patients treated with erenumab. J Neurol Neurosurg Psychiatry. 2022 Aug;93(8):911-912.
³Ibrahimi K, et al. A human trigeminovascular biomarker for antimigraine drugs: A randomized double-blind, placebo-controlled, crossover trial with sumatriptan. Cephalalgia. 2017 Jan;37(1):94-98.
⁴van Lohuizen et al. 2025. Trigeminovascular activity using a forehead dermal blood flow model: preliminary results of a validation study. J Headache and Pain 26 (Suppl 2): 138.
⁵The International Classification of Headache Disorders, 3rd Edition. Cephalalgia. 2018. 38(1):1-211.
⁶Burch et al. Migraine: Epidemiology, Burden, and Comorbidity. Neurol Clin 37 (2019):631–649.
⁷Yeomans DC, et al. Nasal oxytocin for the treatment of psychiatric disorders and pain: achieving meaningful brain concentrations. Transl Psychiatry. 2021. 11(1):388.
⁸Antoni FA and Chadio SE. Essential role of magnesium in oxytocin-receptor affinity and ligand specificity. Biochem J. 1989. 257(2):611-4.
⁹Cai Q, et al. Systematic review and meta-analysis of reported adverse events of long-term intranasal oxytocin treatment for autism spectrum disorder. Psychiatry Clin Neurosci. 2018. 72(3):140-151.
¹⁰Yeomans, DC et al. 2017. US patent US2017368095.
¹¹MaassenVanDenBrink A, et al. Wiping out CGRP: potential cardiovascular risks. Trends Pharmacol Sci. 2016. 37(9):779-788.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA^® (cyclobenzaprine HCl sublingual tablets 2.8 mg), is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace^®Symtouch^®(sumatriptan injection 3 mg) and Tosymra^®(sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA^®in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. In addition, the Company’s CNS portfolio includes TNX-2900 (intranasal oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including long-acting human monoclonal antibody TNX-4800 for Lyme disease prophylaxis, and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.

*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

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

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Brian Korb
astr partners
(917) 653-5122
brian.korb@astrpartners.com

Media Contacts
Deborah Elson
Tonix Pharmaceuticals
deborah.elson@tonixpharmaceuticals.com

Ray Jordan
Putnam Insights
ray@putnaminsights.com

Source: Tonix Pharmaceuticals Holding Corp.

GeoVax Labs (GOVX) – MVA Vaccine Makes Progress Toward Phase 3 For Mpox

Posted on March 26, 2026March 26, 2026 by slightbourne@noblecapitalmarkets.com

Thursday, March 26, 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.

Mpox Vaccine Clinical Supplies Expected To Be Ready Soon. GeoVax announced the completion of clinical supply testing of GEO-MVA, its modified vaccinia ankara (MVA) vaccine for Mpox/smallpox. The release of vaccine that can be used in clinical trials is expected in early April. This is an important milestone in preparation for the Phase 3 trial planned for late FY2026.

Preparation for Phase 3 Bridging Study and Commercialization. GeoVax is preparing for an immune bridging study to show GEO-MVA stimulates an immune response that is non-inferior to a commercial Mpox vaccine. The study was designed to meet requirements for the European Medicines Agency’s expedited development pathway for Marketing Authorization.

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

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

Cardiff Oncology (CRDF) – KOL Discussion Of Onvansertib Supports Our Outperform Rating

Posted on March 26, 2026March 26, 2026 by slightbourne@noblecapitalmarkets.com

Thursday, March 26, 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.

Cardiff Oncology Held A KOL Discussion. On March 25, Cardiff Oncology held a webcast with two world-renown oncologists with experience in drug development and patient treatment. The discussion began with a review of the Phase 2 data by Dr. Mani Mohindru, the Interim CEO. The discussion centered on aspects of the trial, including the outcome data, practical use, and competitive therapies.

The Discussion Included Significance Of Phase 2 Outcomes. The presentation began with a review of Phase 2 data announced in January 2026, with comments by the KOLs. They pointed to the response rate (RR) of 72.2% and the median progression-free survival (PFS) that has not yet been reached. Importantly, onvansertib did not cause additional toxicities to the combination chemotherapy regimen.

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

Release – GeoVax Provides Update on GEO-MVA Program

Posted on March 25, 2026March 25, 2026 by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Clinical Product Release Testing Completed in Support of Pivotal Phase 3 Trial

Atlanta, GA – March 25, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today provided a development update on its GEO-MVA vaccine program for protection against mpox and smallpox, highlighting continued progress toward initiation of its planned pivotal Phase 3 clinical study.

GeoVax announced that GEO-MVA clinical supplies have completed the required release testing and final release of the product for clinical use is scheduled for early April. Upon final release, sufficient clinical material will be available to fully support the planned immune bridging study designed in accordance with guidance from the European Medicines Agency (EMA).

This impending availability of GEO-MVA vaccine clinical material further advances the program towards initiation of the immune bridging study, a critical step toward regulatory Marketing Authorization under the EMA’s expedited development pathway, scheduled to initiate in the second-half of this year.

Advancing Toward a Pivotal Inflection Point

“The availability of GEO-MVA cGMP clinical material marks a significant advancement for the GEO-MVA program,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “With final product release expected shortly, we are entering the final preparatory phase ahead of initiating our immune bridging study positioning GeoVax at a pivotal inflection point, moving toward potential regulatory approval and subsequent commercialization.”

The planned immune bridging study is designed to demonstrate comparability to an approved MVA vaccine using immunological endpoints, consistent with EMA guidance supporting a streamlined development pathway.

Parallel Progress Toward Commercial Readiness

As recently announced, we have initiated outreach discussions in support of potential procurement and preparedness contracting, positioning the Company for rapid GEO-MVA vaccine distribution upon regulatory and/or Emergency Use Licensing issuance. These discussions include organizations that influence or directly procure vaccines for national stockpiles, military preparedness programs, and international outbreak response initiatives.

“We are encouraged by the early engagement with global health and preparedness stakeholders,” Dodd added. “These discussions, alongside our clinical progress, underscore the increasing recognition of the critical need to expand global supply of MVA-based vaccines.”

Addressing a Critical Global Supply Gap

GEO-MVA is being developed to address a significant and well-recognized gap in global vaccine preparedness. Recent mpox outbreaks and evolving epidemiological patterns have reinforced the need for sustained preparedness, including expanded manufacturing capacity and diversified supply source. The current supply of MVA vaccine is concentrated in a single commercial manufacturer, limiting redundancy in a platform considered essential for protection against both mpox and smallpox. GeoVax believes GEO-MVA has the potential to serve as an important additional source of MVA vaccine supply supporting:

National stockpile programs
Global outbreak response efforts
Military and biodefense preparedness initiatives

About GEO-MVA

GEO-MVA is GeoVax’s candidate vaccine for protection against mpox and smallpox based on the Modified Vaccinia Ankara (MVA). The program is advancing under an expedited regulatory pathway supported by EMA scientific advice, which enables potential regulatory approval based on a single immune bridging study demonstrating non-inferiority to an approved MVA vaccine.

Following successful completion of the planned study, GEO-MVA is expected to advance toward regulatory submission and potential commercialization as an additional source of MVA vaccine supply for global preparedness and biodefense programs.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.

Forward-Looking Statements

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

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

Company Contact:

info@geovax.com

678-384-7220

Media Contact:

Jessica Starman

media@geovax.com

Merck Bets $6.7 Billion on a Former Microcap’s CML Drug — TERN Investors Reap the Reward

Posted on March 25, 2026March 25, 2026 by slightbourne@noblecapitalmarkets.com

Merck (NYSE: MRK) announced Tuesday it has entered into a definitive agreement to acquire Terns Pharmaceuticals (Nasdaq: TERN), a clinical-stage oncology company, for $53.00 per share in cash — representing an approximate equity value of $6.7 billion, or roughly $5.7 billion net of acquired cash. The deal carries a 31% premium to Terns’ 60-day volume-weighted average price and a 42% premium to its 90-day VWAP as of March 24, 2026.

The acquisition is a textbook small-cap-to-acquisition story. Less than 18 months ago, Terns was trading below $2 per share with a market cap well under $200 million. By the end of 2025, the stock had surged more than 770% year-to-date on the back of compelling Phase 1 clinical data. As of Tuesday’s announcement, shareholders who held through the volatility are looking at a $53 payday — a return that underscores exactly why early-stage biotech remains one of the most asymmetric bets in the small and microcap universe.

At the center of this deal is TERN-701, an investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI) currently being evaluated in the Phase 1/2 CARDINAL trial for patients with Philadelphia chromosome-positive (Ph+) chronic phase chronic myeloid leukemia (CML). Specifically, the drug targets patients who have already received at least one prior TKI and experienced treatment failure, suboptimal response, or intolerance.

What separates TERN-701 from existing CML therapies is its mechanism and early efficacy signal. The drug is designed to bind to the ABL myristoyl pocket — a distinct binding site from most approved TKIs — giving it the potential to work in patients who have already failed other therapies, including those with difficult resistance mutations like T315I. In clinical data presented through the CARDINAL trial, 64% of efficacy-evaluable patients achieved major molecular response by 24 weeks, with 75% achieving MMR among those treated at doses above 320mg. The safety profile has also been notably clean, with low rates of severe adverse events, minimal blood pressure changes, and low lipase elevation — a meaningful differentiator given the side-effect profiles associated with several competing agents.

The FDA recognized the drug’s potential in March 2024, granting TERN-701 Orphan Drug Designation for the treatment of CML. Merck is now betting that designation translates into a commercially viable, potentially best-in-class therapy within its growing hematology portfolio — which already includes three Phase 3 candidates across leukemias, lymphomas, and myeloproliferative neoplasms.

Merck expects to account for the transaction as an asset acquisition, with the deal expected to close in the second quarter of 2026, pending a successful tender offer and Hart-Scott-Rodino antitrust clearance. The charge will be approximately $5.8 billion, or roughly $2.35 per share, reflected in both Q2 and full-year 2026 results.

For the small and microcap investor community, this deal is more than just a pharma headline. It’s a reminder that the path from sub-$2 clinical-stage company to a multi-billion-dollar buyout target is very much alive — and that the CARDINAL data milestones many overlooked in 2024 were the signals that mattered most.

Ocugen (OCGN) – Raising Price Target After Positive OCU410 Data Reported

Posted on March 25, 2026March 25, 2026 by slightbourne@noblecapitalmarkets.com

Wednesday, March 25, 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.

Top-Line Phase 2 ArMaDa Trial Data Reported. Ocugen reported Phase 2 data for OCU410, its gene therapy for geographic atrophy in dry age-related macular degeneration (GA-dAMD). The data shows clinically meaningful and statistically significant benefit of 31% for treated patients compared with placebo. Based on the trial results, we are including OCU410 revenues in our FY2029 earnings model and raising our price target to $12 per share.

Results Show Preservation of Function and Cell Structure. The primary endpoint showed 31% reduction in lesion growth at the optimal dose (medium) group compared to controls (p< 0.05). A secondary endpoint of photoreceptor cell loss, correlating with visual function, showed a 27% slower rate compared to controls. In addition, 55% of treated patients demonstrated a lesion size reduction of greater than 30% compared with controls.

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

Release NeuroSense Advances Toward Key Regulatory Milestones with Strengthened Data Package and Near-Term Alzheimer’s Readout

Posted on March 24, 2026March 24, 2026 by aweinsoff@channelchek.com

Research News and Market Data on NRSN

CAMBRIDGE, Mass., March 24, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today provided an update on key regulatory and clinical milestones for its lead asset, PrimeC.

Health Canada Pre-NDS Meeting

A pre-New Drug Submission (pre-NDS) meeting with Health Canada has been rescheduled to May 2026.

The decision was made to allow for the inclusion of additional emerging clinical, biomarker and survival data and analyses in the briefing package, which the Company believes will meaningfully strengthen the scientific and clinical foundation supporting PrimeC.

The Company remains focused on advancing PrimeC under the NOC/c pathway in Canada, which is designed to facilitate earlier access to promising therapies addressing serious unmet medical needs.

Alzheimer’s Disease Program Update

The Company expects to report clinical and biomarker results from its Alzheimer’s study in the coming weeks.

Continued Momentum Across Key Programs

NeuroSense continues to advance its clinical and regulatory strategy for PrimeC, supported by our previously disclosed:

Statistically significant survival benefit (65% reduction in risk of death)
Expanding biomarker dataset supporting multi-mechanistic activity
FDA clearance to initiate the pivotal Phase 3 PARAGON trial in ALS

“As we generated additional valuable data, we believe it is strategic to incorporate these findings and analyses into our regulatory interactions,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “Our objective is to present the most comprehensive and robust dataset possible to Health Canada, thereby maximizing the likelihood of a constructive and efficient regulatory pathway. We believe this approach positions the Company ahead of several important value inflection points across its ALS and Alzheimer’s programs expected in 2026.”

About NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

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

About PrimeC

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

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of regulatory filings, reporting of data, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding future development of PrimeC, are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the uncertainty regarding the timing of regulatory filings, meetings and regulatory decisions; outcomes and the timing of current and future clinical trials; the risk the 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; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

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

SOURCE NeuroSense

For further information: For further information: info@neurosense-tx.com, +972 (0)9 799 6183

Release – Ocugen Announces Topline 12-month Data from Phase 2 ArMaDa Clinical Trial Evaluating OCU410 Modifier Gene Therapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Posted on March 24, 2026March 24, 2026 by aweinsoff@channelchek.com

Research News and Market data on OCGN

March 24, 2026

PDF Version

Optimal dose intended for Phase 3 demonstrates statistically significant reduction in lesion growth (31%) versus control at 12 months (p< 0.05)
Potential 2X treatment benefit compared to 15% and 22% reductions reported for currently approved therapies at 12 and 24 months, respectively
No serious adverse events and no adverse events of special interest related to OCU410 reported to date

MALVERN, Pa., March 24, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced positive 12-month data from the Phase 2 ArMaDa clinical trial evaluating OCU410 (AAV5-RORA), its novel modifier gene therapy for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD). The global prevalence of dAMD is 266 million worldwide, and GA affects approximately 2-3 million people in the United States (U.S.) and Europe. Importantly, this number is expected to increase significantly as populations age.

There are limited options for patients with dAMD in the U.S. and current therapies require 6–12 injections per year indefinitely, leading to substantial burden and significant dropout rates in real-world practice. Outside of the U.S., there are no approved products available.

Key findings from Phase 2 include:

31% reduction in lesion growth in the optimal dose (medium) group compared to control (p< 0.05)
27% slower rate of ellipsoid zone (EZ) loss compared to control, indicating structural preservation of photoreceptors, which correlates with visual function
55% of treated patients demonstrated ≥30% lesion size reduction vs. control
Subgroup analysis (subjects with baseline GA lesions ≥5 mm² and ≤17.5 mm²) showed 33% reduction in lesion growth compared to control in medium dose OCU410 with similar reductions in the high dose group

The Phase 2 clinical trial builds directly on the clean safety profile observed in Phase 1 with no OCU410-related serious adverse events observed and no cases of endophthalmitis, retinal detachment, vasculitis, choroidal neovascularization, or ischemic optic neuropathy reported to date.

GA is a multifactorial disease with a complex etiology that involves genetic and environmental factors. The current treatment options for GA in the U.S. are limited to those targeting a single mechanism—the complement pathway. By contrast, OCU410 is a first-in-class RORA-based gene therapy designed to support central retina and photoreceptor integrity through a multi-pathway mechanism—targeting drusen, inflammation, oxidative stress, and complement activation.

“We have confirmed robust treatment effect from a well-controlled Phase 2 trial of a genetic medicine for GA. Now we can move on to Phase 3 with a high degree of confidence,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “This moves us one step closer to bringing a transformative one-time treatment to GA patients globally who are desperately seeking rescue from vision loss.”

“Our Phase 2 data consistently demonstrates statistically significant reduction of GA lesion growth after treatment with OCU410 optimal dose, and we continue to benchmark these results against natural history data to contextualize the magnitude of effect,” said Huma Qamar, MD, MPH, CMI, Chief Medical Officer of Ocugen. “We are incorporating these learnings into an anticipated Phase 3 pivotal confirmatory trial with up to 300 subjects and an adaptive design powered at over 95%.”

“There remains a considerable unmet need in treating patients with GA and I am encouraged by the various analyses of the Phase 2 OCU410 data,” said Lejla Vajzovic, MD, FASRS, Director, Duke Surgical Vitreoretinal Fellowship Program, Associate Professor of Ophthalmology with Tenure, Adult and Pediatric Vitreoretinal Surgery and Disease, Duke University Eye Center, and Chair, Ocugen Retina Scientific Advisory Board. “In addition to the strong efficacy and safety data, OCU410 has the potential to eliminate the chronic treatment burden associated with monthly or every-other-month intravitreal injections and to reduce treatment attrition driven by patient fatigue.”

In the Phase 2 study, the safety and efficacy of OCU410 in patients with GA secondary to dAMD are being assessed. Fifty-one (51) patients aged 50 years and older with GA lesions within the foveal or non-foveal region were randomized 1:1:1 to receive a single subretinal administration of OCU410 at a medium dose of 1 × 10¹⁰ vector genomes per eye, a high dose of 3 × 10¹⁰ vector genomes per eye, or no treatment in the control group; each injection volume was 200 microliters. Of note, choroidal neovascularization in the fellow eye was not exclusionary, and patients with prior exposure to pegcetacoplan or avacincaptad pegol were eligible following a three-month washout.

The primary endpoint was change in GA lesion size at 12 months, measured in square millimeters by fundus autofluorescence, an FDA-accepted structural endpoint used in recent GA registration trials. Exploratory endpoints included EZ preservation on OCT a key biomarker for photoreceptor integrity, which correlates with visual function.

Ocugen plans to initiate the OCU410 Phase 3 registrational trial in the third quarter of 2026 in line with the Company’s goal of three BLA filings in three years.

About dAMD and Geographic Atrophy
Geographic atrophy is an advanced form of dAMD characterized by progressive degeneration of the macula, leading to irreversible central vision loss. Millions of patients worldwide are affected by GA, with a particularly high burden in aging populations in the United States and Europe. Despite recent approvals, treatment options remain limited and require chronic intravitreal injections, underscoring the need for innovative, durable therapies that address multiple disease mechanisms. dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula, the portion of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function, and central vision impairment. dAMD accounts for 85-90% of all AMD cases.

About OCU410
OCU410 is an investigational, subretinal injection, AAV5-based gene therapy that delivers RORA (retinoid-related orphan receptor alpha), a nuclear receptor that regulates key pathways involved in retinal homeostasis, including oxidative stress response, complement regulation, inflammation, and lipid metabolism. OCU410 is being developed as a one-time gene therapy for patients with GA secondary to dry AMD. OCU410 has received Advanced Therapy Medicinal Product (ATMP) classification from the European Medicines Agency.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410 to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study 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 of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com

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

Posted on March 23, 2026March 24, 2026 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

March 23, 2026 4:32pm EDTDownload as PDF

Monday, March 30: Phase 1 data on TNX-4800 (long-acting anti-Borrelia OspA human monoclonal antibody) for the seasonal prevention of Lyme disease

Wednesday, April 1: Animal and in vitro studies on TNX-801 (horsepox, live virus vaccine) for the prevention of smallpox and mpox

Wednesday, April 1: Horsepox as a modular antigen-delivery system for broad and sustained immunity in novel vaccines to protect against other pathogens

BERKELEY HEIGHTS, N.J., March 23, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced an oral presentation of Phase 1 data on TNX-4800 (formerly known as mAb 2217LS)^1,2, a long-acting human monoclonal antibody (mAb) that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the causative agent of Lyme disease in humans in the U.S., at the World Vaccine Congress Washington 2026 held in Washington, D.C., March 30-April 2, 2026.

The Company’s Farooq Nasar, PhD, Director, Virology will present data on TNX-801, the Company’s attenuated, live orthopoxvirus (horsepox) vaccine candidate with the potential capability to protect against smallpox and mpox. Finally, Christopher Cooper, PhD, Director, Immunology at Tonix will serve as moderator on a panel discussing modular antigen-delivery systems in novel pox-based vaccines.

TNX-4800 Presentation Details

Title: A Long-Acting Monoclonal Antibody for Seasonal Prevention of Lyme Disease
Location: Room 202B
Date and Time: March 30, 2026, 10:10 a.m. ET
Session Category: Measuring Breadth & Emerging Targets
Presenters: Mark S. Klempner, MD, Professor of Medicine at UMass Chan Medical School, inventor of TNX-4800, and Principal Investigator of the study

Other Session Details

Title: A Live Attenuated, Minimally Replicative MPOX Vaccine
Location: Room 202A, Level 2
Date and Time: April 1, 2026, 10:10 am ET
Session Category: Emerging & Re-Emerging Diseases
Presenter: Farooq Nasar, PhD, Director, Virology, Research and Development Center (RDC), Tonix Pharmaceuticals

Title: Poxvirus as a Modular Antigen-Delivery System for Broad and Sustained Immunity
Location: Room 20A, Level 2
Date and Time: April 1, 2026, 3:25 p.m. ET
Session Category: Emerging & Re-Emerging Diseases
Moderator: Christopher Cooper, PhD, Director, Immunology, RDC, Tonix Pharmaceuticals

About TNX-4800
TNX-4800 (formerly known as mAb 2217LS) is a human monoclonal antibody with an engineered extended half-life that targets the outer-surface protein A (OspA) on Lyme-causing Borrelia bacteria. When TNX-4800-containing blood is ingested by the tick, TNX-4800 kills and blocks the maturation of Borrelia burgdorferi in the mid-gut of infected deer ticks. The Company in-licensed TNX-4800 from UMass Chan Medical School in 2025. Published work in animals showed that TNX-4800 was 95% effective in preventing infection after a six-day challenge with ticks infected with Borrelia burgdorferi.¹ TNX-4800 was derived from mAb 2217 by amino acid substitutions in its crystallizable fragment (Fc) domain which serve to prolong the serum half-life. A single administration in the Spring is designed to potentially provide immunity within two days and maintain protective antibody titers for the entire tick season, providing pre-exposure prophylaxis against Lyme disease without relying on the recipient’s immune system to generate antibodies. By delivering a well-characterized antibody directly, TNX-4800 has been shown to block transmission of Borrelia burgdorferi from ticks to animals. TNX-4800 also sidesteps the multidose schedules required for OspA vaccines in development³ and the FDA-approved vaccine that was withdrawn from the market.⁴ The Company expects to have GMP investigational product available for clinical testing in early 2027. Pending FDA clearances, a field study is expected to initiate enrollment in the first half of 2027, and a controlled human infection model (CHIM) study in 2028.

About the TNX-4800 Phase 1 Study
TNX-4800 was studied in a randomized, double-blind, sequential dose-escalation study (NCT04863287) that evaluated safety, tolerability, pharmacokinetics (PK), and immunogenicity of TNX-4800 in healthy adults. 44 subjects were randomized, and 41 completed the study. Subjects received a single subcutaneous (SC) administration of placebo or TNX-4800 at 0.5, 1.5, 5, or 10 mg/kg. Safety was assessed via clinical and lab evaluations. Drug exposure increased by approximately 25 times for a 20 times increase in dose. Serum TNX-4800 was measurable at the earliest sampling time of 24 hours, indicating rapid systemic absorption. TNX-4800 concentrations remained quantifiable for >200 days in 80% of volunteers at the lowest dose and for up to 350 days in the majority of volunteers at higher doses (i.e., ≥ 1.5 mg/kg). Mean half-life ranged from 62-69 days across groups. Serum concentrations remained quantifiable for up to 12 months in most subjects. Mean exposure for the 10 mg/kg cohort was less than 20% of the highest exposures in a rat toxicology study. Anti-drug antibodies (ADA) were detected in <10% of treated subjects, with no impact on PK. Most adverse events were mild or moderate. TNX-4800 was determined to be generally safe and well tolerated.

About Lyme Disease
In the United States, Lyme disease is caused by the bacterium Borrelia burgdorferi. Lyme disease remains the most common vector-borne infection in the United States, and its incidence is climbing each year, due in part to global changes in climate expanding the habitat range for ticks.⁵ It occurs most commonly in the Northeast, mid-Atlantic, and upper-Midwest regions. Lyme disease bacteria are transmitted through the bite of infected Ixodes ticks. Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, heart, and nervous system. Laboratory testing is helpful if used correctly and performed with FDA-cleared tests. Although many cases of Lyme disease can be treated successfully with antibiotics, diagnosis and treatment are often delayed or missed. Chronic Lyme is considered an Infection Associated Chronic Illness (IACI), and is a chronic, debilitating disease state characterized by joint and muscle pain, fatigue, and other symptoms.⁶

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

Citations
¹Schiller ZA, et al. J Clin Invest. 2021 131(11):e144843.
²Wang Y, et al. J Infect Dis. 2016. 214(2):205-11.
³Comstedt P, et al. Vaccine. 2015 33(44):5982-8.
⁴Connaught’s (ImuLyme™) and SmithKline Beecham’s (LYMErix™) Lyme disease vaccines were withdrawn. Nigrovic LE, et al. Epidemiol Infect. 2007 135(1):1-8. doi: 10.1017/S0950268806007096. Epub 2006 Aug 8. PMID: 16893489; PMCID: PMC2870557.
⁵Gomes-Solecki M, et. al. Clin Infect Dis. 2020 70(8):1768-1773. doi: 10.1093/cid/ciz872. PMID: 31620776; PMCID: PMC7155782.
⁶National Academies of Sciences, Engineering, and Medicine. 2025. Charting a Path Toward New Treatments for Lyme Infection-Associated Chronic Illnesses. Washington, DC: The National Academies Press. https://doi.org/10.17226/28578.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA^® (cyclobenzaprine HCl sublingual tablets 2.8 mg), is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace^® SymTouch^® (sumatriptan injection 3 mg) and Tosymra^® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. In addition, the Company’s CNS portfolio includes TNX-2900 (intranasal oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including long-acting human monoclonal antibody TNX-4800 for Lyme disease prophylaxis, and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.

*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

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

Forward Looking Statements

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Brian Korb
astr partners
(917) 653-5122
brian.korb@astrpartners.com

Media Contacts
Deborah Elson
Tonix Pharmaceuticals
deborah.elson@tonixpharma.com

Ray Jordan
Putnam Insights
ray@putnaminsights.com

Source: Tonix Pharmaceuticals Holding Corp.

Released March 23, 2026

Release – Ocugen to Host Webcast on Tuesday, March 24 at 8 a.m. EDT to Discuss Phase 2 Clinical Trial Data for OCU410—Modifier Gene Therapy for Geographic Atrophy

Posted on March 23, 2026March 23, 2026 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

March 23, 2026

PDF Version

MALVERN, Pa., March 23, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it will host a conference call and live webcast with key opinion leaders (KOLs) and Ocugen executive leadership to discuss the full data set from the Phase 2 ArMaDa clinical trial evaluating OCU410 for geographic atrophy (GA), late-stage dry age-related macular degeneration (dAMD) at 8 a.m. EDT on Tuesday, March 24, 2026.

KOLs leading the webcast include:

Lejla Vajzovic, MD, FASRS, Professor of Ophthalmology, Director of CME-Ophthalmology, Duke University School of Medicine & Chairman, Ocugen Scientific Advisory Board
Jay Chhablani, MD, Professor, University of Pittsburgh and UPMC Vision Institute, and President of NetraMind

Victor H. Gonzalez, MD, Retinal Surgeon, Valley Retina Institute, McAllen, Texas, Faculty at University of Texas Rio Grande Valley; and Syed M. Shah, MD, Vice Chair for Research and Digital Medicine, Director of Retina Service, Department of Ophthalmology at Emplfiy Health, La Crosse, WI, Ibn al-Haytham Professor, Department of Ophthalmology, Aga Khan University will join to answer questions.

Attendees are invited to participate on the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 4629682
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available following the event on the Ocugen investor site.

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

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, 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. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com

Eledon Pharmaceuticals (ELDN) – FY2025 Reported With Tegoprubart Updates and Phase 3 Expectations

Posted on March 23, 2026March 23, 2026 by slightbourne@noblecapitalmarkets.com

Monday, March 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.

Tegoprubart Trials To Advance In FY2026. Eledon reported a 4Q loss of $10.4 million or $(0.11) per share and a FY2025 loss of $45.6 million or $(0.52) per share. The FY Total Operating Expenses were $83.3 million, with non-cash items (including changes in the fair value of warrant liabilities) of $33.4 million. Net Loss excluding these items would have been $79.1 million for full year. Updates for tegoprubart clinical development were also confirmed with the announcement. Cash on December 31, 2025 was $45.6 million.

Clinical Trials In Transplantation Have Several Milestones Ahead. Eledon expects to meet with the FDA to discuss plans for a Phase 3 tegoprubart trial for prevention of kidney transplant rejection. We expect the guidance to clarify required endpoints and could lead to the start of Phase 3 by year-end. Guidance is also expected for Islet cell transplantation in diabetes and xenotransplantation.

Get the Full Report

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

Release – Cardiff Oncology to Host Key Opinion Leader Discussion Focusing on First-Line RAS-mutated Metastatic Colorectal Cancer

Posted on March 20, 2026March 20, 2026 by aweinsoff@channelchek.com

Research News and Market Data on CRDF

March 20, 2026

PDF Version

SAN DIEGO, March 20, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that the Company will host a key opinion leader (KOL) webinar to discuss the emergent treatment landscape in first-line RAS-mutated metastatic colorectal cancer (mCRC). The webinar will take place on Wednesday, March 25th, 2026, at 4:30 p.m. ET.

The webinar will feature KOLs Scott Kopetz, M.D., Ph.D., FACP and Heinz-Josef Lenz, M.D., who will join Mani Mohindru, PhD, interim Chief Executive Officer, to discuss onvansertib’s existing clinical data and its potential as a novel therapeutic approach in the management of mCRC.

About the KOLs

Scott Kopetz, M.D., Ph.D., FACP, is a Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center and an internationally recognized leader in colorectal cancer research and translational oncology. Dr. Kopetz’s work has helped establish new treatment approaches for molecularly defined colorectal cancers, including therapies targeting BRAF-mutated metastatic disease. He serves in multiple national leadership roles supporting gastrointestinal cancer research and clinical trial development and has led numerous Phase I–III clinical studies focused on improving outcomes for patients with GI malignancies. His research integrates molecular profiling and translational science to advance precision medicine strategies and overcome treatment resistance in colorectal cancer.

Heinz Josef-Lenz, M.D., is a University Professor of Medicine, Population and Public Health Sciences and Cancer Biology; Professor of Medicine and Preventive Medicine of USC. He serves as Co-Leader of the Gastrointestinal Cancers Program and Co-Director of the USC Center for Cancer Drug Development. Dr. Lenz’s research focuses on molecular mechanisms of cancer development, drug resistance, and biomarker-driven treatment approaches in gastrointestinal cancers, including colorectal cancer. He has authored numerous peer-reviewed publications and holds leadership roles across national oncology research initiatives, including service on National Cancer Institute committees and cooperative clinical trial groups guiding translational and clinical research in GI oncology.

KOL Webinar Information

Interested parties can register for and access the live webcast by visiting the “Events” section of the Cardiff Oncology website. The webcast replay will be available after the conclusion of the discussion.

About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (“mCRC”), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.

For more information, please visit https://www.cardiffoncology.com.

Investor Contact:
Candice Masse
Astr Partners
candice.masse@astrpartners.com

Media Contact:
Amy Bonanno
Lyra Strategic Advisory
abonanno@lyraadvisory.com

Collegium Pharmaceutical Doubles Down on ADHD With $650M AZSTARYS Acquisition

Posted on March 20, 2026March 20, 2026 by slightbourne@noblecapitalmarkets.com

While macro headlines continue to dominate investor attention, small-cap specialty pharma company Collegium Pharmaceutical (NASDAQ: COLL) is quietly executing a disciplined growth strategy — and its latest move is hard to ignore.

The Stoughton, Massachusetts-based company announced a definitive agreement to acquire AZSTARYS, an FDA-approved ADHD treatment, from privately held Corium Therapeutics for $650 million in cash at closing, with the potential for up to $135 million in additional milestone payments tied to future commercial and regulatory targets. The deal is expected to close in the second quarter of 2026.

What Is AZSTARYS and Why Does It Matter?

AZSTARYS is a central nervous system stimulant combining immediate-release and long-acting components in a single capsule, approved for patients aged six and older with Attention Deficit Hyperactivity Disorder. It is one of the more differentiated products in the ADHD space precisely because of that dual-mechanism delivery — something that sets it apart from a crowded field of single-mechanism competitors.

The commercial traction is already there. AZSTARYS generated more than 760,000 prescriptions in 2025, and Collegium projects the drug will contribute over $50 million in pro forma net revenue in just the second half of 2026 — assuming the deal closes on schedule. Six Orange Book-listed patents, most of which do not expire until December 2037, provide long-runway exclusivity that gives this asset real staying power on Collegium’s balance sheet.

Collegium already markets Jornay PM, a delayed-release methylphenidate treatment for ADHD. Adding AZSTARYS gives the company two commercially differentiated products targeting the same condition but with distinct dosing profiles — a smart way to expand market penetration without cannibalizing existing revenue.

The deal structure reflects that discipline. Collegium plans to fund the acquisition using cash on hand and a previously arranged $300 million delayed-draw term loan, with management projecting post-close net leverage of approximately two times estimated 2026 combined adjusted EBITDA. Run-rate cost synergies are expected to exceed $50 million within twelve months of closing, driven by Collegium leveraging its existing ADHD commercial infrastructure rather than building a parallel one from scratch.

The transaction has been unanimously approved by the boards of both companies and is subject to customary regulatory approvals, including Hart-Scott-Rodino clearance.

At a market cap of approximately $1.15 billion, Collegium is doing something many larger companies struggle with — making acquisitions that are both strategically coherent and financially disciplined. The AZSTARYS deal is not a moonshot. It is a calculated bet on a proven, revenue-generating asset with durable patent protection in a therapeutic category — ADHD — that continues to see strong and growing demand across both pediatric and adult patient populations.

Needham & Company reaffirmed its Buy rating on COLL this week with a price target of $56, representing meaningful upside from the stock’s current trading range near $36. The broader analyst consensus sits at Buy, though the stock has traded down from its 52-week high near $51 amid broader market volatility.

For investors focused on the small and microcap space, Collegium’s approach offers a case study in how companies under $2 billion in market cap can use M&A not as a hail mary, but as a precision tool for compounding long-term value.