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.
Preparing For AVERSA Fentanyl Clinical Testing. Nutriband and its partner Kindeva announced that it has completed commercial manufacturing processes and scale-up for AVERSA Fentanyl, its abuse-deterrent fentanyl patch. This allows the company begin manufacturing clinical supplies and filing the IND (Investigational New Drug application) for the Phase 1 clinical study within the timeframe we anticipated. Only a single Phase 1 study is needed to file the application for marketing approval.
Manufacturing Completion Is A Significant Milestone. This scale-up is a significant step that demonstrates the ability to apply Kindeva’s transdermal patch technology for commercial scale production of AVERSA Fentanyl patches. We expect the IND filing to be completed shortly, with clinical testing to follow as expected.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
MAIA Makes Its Third Supply Agreement. MAIA announced that it has entered a supply agreement with Genentech/Roche to test THIO (ateganosine) in combination with Tecentriq (atezolizumab, Roche’s PD-L1 checkpoint inhibitor) for the treatment of several hard-to-treat cancers. MAIA now has supply agreements to test THIO in combination with checkpoint inhibitors from three global pharmaceutical companies, which we see as an indicator of interest for future partnerships.
PD-1 or PD-1L? That Is The Question. Checkpoint inhibitors block the interaction of the surface proteins PD-1 (programmed death receptor-1) with PD-1L (the programed death receptor-1 ligand). When the PD-1 receptor binds to the PD-1L ligand, it inhibits the immune response. Checkpoint inhibitors are monoclonal antibody drugs against PD-1 or PD-L1 that block this interaction, allowing cancer cells to be recognized by a patient’s immune system and killed.
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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.
Nutriband and Kindeva have completed commercial manufacturing process scale-up for its lead product Aversa™ Fentanyl, an abuse-deterrent fentanyl patch
Nutriband is partnering with Kindeva to develop Aversa™ Fentanyl which combines Nutriband’s Aversa™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch
ORLANDO, Fla., June 18, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has completed commercial manufacturing process scale-up for its lead product, Aversa™ Fentanyl, with Kindeva, a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products.
Nutriband is partnering with Kindeva to develop Aversa™ Fentanyl which combines Nutriband’s Aversa™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch. Aversa Fentanyl is manufactured at Kindeva’s state-of-the-art transdermal manufacturing facility located in the United States. The next step is to manufacture clinical supplies and file an Investigational New Drug (IND) application with the FDA to initiate a human abuse liability clinical study.
“We are excited to achieve this commercial development milestone with our partner, Kindeva. Completing the commercial manufacturing scale-up is an important step towards development of a commercially viable product and eventual NDA filing. This achievement demonstrates the compatibility of the Aversa™ abuse deterrent platform technology with established transdermal patch manufacturing processes. Aversa Fentanyl has the potential to be the first abuse deterrent pain patch on the market,” said Gareth Sheridan, CEO, Nutriband.
Nutriband’s AVERSA™ abuse-deterrent technology can be 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 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.
AVERSA Fentanyl has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million.1 While initially concentrating on the US market, the unmet medical need for adequate pain management is a global problem, and our goal is to make AVERSA a global solution strategically targeting all major medical markets in the world.
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.
1 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.
About Kindeva
At Kindeva, we manufacture more tomorrows for patients worldwide. With best-in-class facilities and comprehensive CDMO services, we offer more than manufacturing—we deliver strategic value. Our global network of 10 manufacturing and R&D sites offer exceptional integrated knowledge and capabilities, including Annex 1-compliant state-of-the-art aseptic fill finish capacity and next-generation sustainable inhalation propellant technology. By combining expertise in injectable, pulmonary, nasal and dermal drug delivery, we help meet the demands of today and deliver the possibilities of tomorrow. Find out more at https://www.kindevadd.com.
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.
Agreement to support future studies investigating the combination of ateganosine and atezolizumab for safe and effective cancer treatments
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced its entry into a clinical master supply agreement with Roche for future studies investigating the combination of MAIA’s telomere-targeting agent ateganosine (THIO), sequenced with Roche’s checkpoint inhibitor (CPI), atezolizumab (Tecentriq®), for the treatment of multiple hard-to-treat cancers.
“In preclinical studies, ateganosine was found to be highly synergistic and effective in combination with Roche’s anti-PD-L1 agent atezolizumab,” said MAIA Chairman and CEO Vlad Vitoc, M.D. “We are pleased to partner with world-renowned Roche and we look forward to further strengthening our mission to find safe and effective cancer treatments.”
About Ateganosine
Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activate both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
Forward-Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward-looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Highlights from Noble’s Emerging Growth Virtual Conference. Vijay Kotte, CEO, presented at Noble’s Virtual Equity conference June 4 & 5th. Mr. Kotte highlighted the company’s proprietary technology, consumer-centric Medicare policy platform, and gave an update on recent developments. A rebroadcast is available here.
Purpose-built technology. Mr. Kotte emphasized the company’s use of proprietary machine learning tools alongside licensed agents to tailor recommendations to each consumer’s needs. With Medicare beneficiaries typically choosing from 40–50 plans, this technology plays a key role in efficiently identifying the most suitable options.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Shares Expected to Begin Trading on Split-Adjusted Basis on June 20, 2025
LOS ALTOS, Calif., June 17, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (NASDAQ: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it will implement a 1-for-10 reverse split of the issued shares of its common stock, effective at 4:01 p.m. Eastern Time on June 18, 2025. The Company’s common stock is expected to begin trading on a split-adjusted basis when the market opens on June 20, 2025, and will continue to trade on The Nasdaq Capital Market under the symbol “UNCY.” The new CUSIP number for the common stock will be 90466Y 202.
The reverse stock split is intended to increase the bid price of the common stock to enable the Company to regain compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market. The Company’s stockholders authorized the reverse stock split at the Company’s annual meeting of stockholders held on June 9, 2025 and granted the board the authority to determine a final reverse split ratio.
When the reverse stock split becomes effective, every ten (10) shares of the Company’s common stock issued and outstanding or held by the Company in treasury will automatically be combined and reclassified into one (1) share of common stock. No fractional shares will be issued as a result of the reverse stock split. Stockholders who would otherwise be entitled to receive a fractional share will instead automatically have their fractional interests rounded up to the next whole share, after aggregating all the fractional interests of a holder resulting from the reverse stock split. The reverse stock split will affect all stockholders uniformly and will not change any stockholder’s percentage ownership interest or any stockholder’s proportionate voting power, except for immaterial changes that may result from the treatment of fractional shares. The reverse stock split will not change the number of authorized shares of the Company’s common stock or the par value per share of the Company’s common stock.
The reverse stock split will reduce the number of issued and outstanding shares of the Company’s common stock from approximately 126,409,281 to approximately 12,640,929.
As a result of the reverse stock split, proportionate adjustments will be made to the per share exercise prices of, and the number of shares underlying, the Company’s outstanding stock options, as well as to the number of shares available for future awards granted under the Company’s stock incentive plans. In addition, proportionate adjustments will be made to the per share exercise prices of, and the number of shares underlying, outstanding warrants to purchase shares of the Company’s common stock. Further, proportionate adjustments will also be made to the per share conversion price of the Company’s series A and series B preferred stock, pursuant to their respective terms.
The combination of, and reduction in, the issued shares of common stock as a result of the reverse stock split will occur automatically at the effective time of the reverse stock split without any additional action on the part of the Company’s stockholders. The Company’s transfer agent, Pacific Stock Transfer Company, is acting as the exchange agent for the reverse stock split and will send stockholders of record holding their shares electronically in book-entry form a transaction notice indicating the number of shares of common stock held after the reverse stock split. Stockholders who hold their shares through a broker, bank, or other nominee will have their positions adjusted to reflect the reverse stock split, subject to their broker, bank, or other nominee’s particular processes, and are not expected to be required to take any action in connection with the reverse stock split.
Additional information regarding the reverse stock split can be found in the Company’s definitive proxy statement for the annual meeting of stockholders of the Company held on June 9, 2025, which was filed with the U.S. Securities and Exchange Commission on April 30, 2025, a copy of which is available at www.sec.gov and on the Company’s website.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information about Unicycive, visit Unicycive.com and follow us on LinkedIn and X. For more information, please visit Unicycive.com and follow us on LinkedIn and X.
Forward-Looking Statements
The Company cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to the timing, completion and effect of the reverse stock split and the Company’s ability to regain compliance with Nasdaq’s minimum bid price requirement and continue to have its common stock listed on The Nasdaq Capital Market. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, the risk that Nasdaq may not process the reverse stock split on the expected timeline; the risk that after the reverse stock split the closing bid price of the Company’s common stock is not at least $1.00 per share for a minimum of ten consecutive trading sessions; the potential for Nasdaq to suspend trading in or to delist the Company’s common stock. Forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of risks and uncertainties the Company faces, you are encouraged to review the documents the Company files with the SEC including the Company’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Investor Contacts:
Kevin Gardner LifeSci Advisors kgardner@lifesciadvisors.com
Media Contact:
Rachel Visi Real Chemistry redery@realchemistry.com
Key Points: – Lilly acquires Verve Therapeutics to develop one-time gene editing treatments for cardiovascular disease. – Verve’s VERVE-102 targets the PCSK9 gene to lower cholesterol with a single dose. – Deal strengthens Lilly’s position in cardiometabolic and genetic medicine sectors.
In a move set to transform the landscape of cardiovascular care, Eli Lilly and Company (NYSE: LLY) announced its acquisition of Verve Therapeutics, Inc. (Nasdaq: VERV), a clinical-stage biotechnology firm focused on gene editing treatments for atherosclerotic cardiovascular disease (ASCVD). The transaction, valued at up to $1.3 billion, is aimed at accelerating the development of groundbreaking one-time treatments that could offer lifelong benefits to patients with high cardiovascular risk.
Verve’s lead program, VERVE-102, is a promising in vivo gene editing therapy targeting the PCSK9 gene—an established regulator of LDL cholesterol levels. Currently in a Phase 1b clinical trial, VERVE-102 has been granted Fast Track designation by the FDA and is designed for individuals with heterozygous familial hypercholesterolemia (HeFH) and certain forms of premature coronary artery disease. If successful, the treatment could eliminate the need for chronic medication by permanently modifying liver DNA to lower harmful cholesterol levels.
“This acquisition marks a bold step toward shifting cardiovascular care from lifelong therapy to one-time cures,” said Ruth Gimeno, Lilly’s Group VP of Diabetes and Metabolic Research and Development. “Combining Lilly’s global scale with Verve’s scientific innovation positions us to lead the next generation of cardiometabolic treatment.”
The purchase agreement includes an upfront cash payment of $10.50 per share—totaling approximately $1.0 billion—along with an additional contingent value right (CVR) worth up to $3.00 per share, tied to future clinical milestones. If all conditions are met, the total deal value could reach $1.3 billion. The acquisition represents a 113% premium over Verve’s 30-day average stock price prior to the announcement.
Founded just seven years ago, Verve has rapidly built a pipeline of one-time gene editing therapies aimed at the three core lipid-related drivers of ASCVD: low-density lipoproteins, triglycerides, and lipoprotein(a). In addition to VERVE-102, Verve is advancing VERVE-201 (targeting ANGPTL3 for refractory hypercholesterolemia) and VERVE-301 (targeting LPA for lipoprotein(a)-related risks).
“Joining Lilly is the natural next step in our mission to bring one-time gene editing treatments to people with cardiovascular disease,” said Dr. Sekar Kathiresan, co-founder and CEO of Verve. “Lilly’s world-class capabilities will significantly accelerate our clinical development and commercial reach.”
The deal is expected to close in Q3 2025, pending customary regulatory approvals and the successful tendering of Verve shares. Several major shareholders, including co-founders and investors affiliated with GV (formerly Google Ventures), have already agreed to tender approximately 17.8% of Verve’s outstanding stock.
For Lilly, this acquisition reinforces its strategic commitment to expanding in cardiometabolic and genetic medicine sectors—areas already central to its long-term growth strategy. As the race to develop durable, gene-based solutions for chronic illnesses intensifies, the Verve acquisition could position Lilly at the forefront of an entirely new therapeutic paradigm.
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
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.
OCU410ST Cleared To Begin Confirmatory Trial. Ocugen announced that the FDA has approved its IND amendment to allow OCU410ST to begin its Phase 2/3 pivotal confirmatory trial. This will become the second Ocugen product to move into a Phase 2/3 confirmatory trial, and keeps the company on schedule to meet its goal of submitting three BLAs in the three years between 2026-28.
Brief Description of Stargardt Disease. Stargardt disease is a rare autosomal recessive disease caused by mutations in the ABCA4 gene in the retina. Progressive loss of photoreceptor cells in the retina typically starts at a young age, leading to blindness. Ocugen has received Orphan Drug designation and Rare Pediatric Disease Designation (RPDD) for diseases associated with ABCA4 diseases, including Stargardt, retinitis pigmentosa 19, and cone-rod dystrophy 3.
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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.
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.
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.
GEO-MVA Gets An Accelerated Pathway To European Approval. GeoVax announced that it has received guidance from the EMA (European Medicines Agency) that provides an accelerated path to approval for GEO-MVA, its modified vaccinia ankara (MVA) based vaccine for smallpox/Mpox. It will only be required to conduct immune-bridging and toxicity studies before moving directly to Phase 3. This cuts several years from development time and saves many millions of dollars in clinical expenses.
Only Phase 3 Will Be Needed. The Committee for Medicinal Products for Human Use (CHMP) of the EMA stated that only requirements before beginning a Phase 3 study will be a non-clinical immuno-bridging and toxicity studies. No Phase 1 or Phase 2 studies are required. An MAA regulatory application can be submitted after a single, Phase 3 immuno-bridging study against the approved MVA vaccine (Imvanex or Jynneos, from Bavarian Nordic). The proposed endpoints of the study would be demonstration of immunogenicity to show non-inferiority.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
MALVERN, Pa., June 16, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST, a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies). The FDA previously granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19, and cone-rod dystrophy 3.
“We have had a highly productive and collaborative engagement with the FDA’s Center for Biologics Evaluation and Research (CBER) in establishing the pivotal confirmatory trial for OCU410ST,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen. “It’s evident that there is a real sense of urgency by the agency in providing treatment options for patients who currently have nothing available to them. As we initiate the Phase 2/3 registration trial, we are expediting the clinical development of OCU410ST by two to three years and potentially providing an innovative gene therapy to patients desperate for a treatment option.”
Positive data from the Phase 1 GARDian trial for OCU410ST demonstrated:
A favorable safety and tolerability profile with no serious adverse events related to OCU410ST, including no cases of ischemic optic neuropathy, vasculitis, intraocular inflammation, endophthalmitis or choroidal neovascularization and no adverse events of special interest
Considerably slower lesion growth—48% at 12-month follow up in evaluable treated eyes when compared to untreated eyes
Statistically significant (p=0.031) improvement with clinically meaningful, nearly 2-line gain in visual function (BCVA) at 12-month follow-up in evaluable treated eyes when compared to untreated eyes
The Phase 2/3 clinical trial for OCU410ST will enroll 51 participants diagnosed with Stargardt disease. Of these, 34 will receive a one-time subretinal injection of OCU410ST (200 μL at a concentration of 1.5 × 10¹¹ vector genomes/mL) in the eye with poorer visual acuity, while 17 will be assigned to an untreated control group. The primary objective of the trial is to evaluate the reduction in atrophic lesion size. Key secondary endpoints include improvements in best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA), compared to controls. Data from the one-year follow-up will be used to support the company’s Biologics License Application (BLA).
“The initiation of this pivotal Phase 2/3 study represents a significant milestone in our commitment to bringing transformative genetic therapies to individuals affected by Stargardt disease—a progressive and debilitating condition,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “The recent RPDD granted by the FDA for this program further underscores the urgent need for innovative treatment options for children living with Stargardt disease. OCU410ST, developed through our proprietary modifier gene therapy platform, is designed to target the underlying biological mechanisms of the disease.”
Approximately 100,000 patients in U.S. and Europe combined and 1 million patients globally live with Stargardt disease. Stargardt and ABCA4-associated retinopathies are genetically complex, involving more than 1,200 known mutations and addressing this condition with traditional gene therapy or gene editing approaches remains highly challenging.
“Stargardt disease represents a significant unmet medical need, particularly among children and young adults,” said Lejla Vajzovic, MD, FASRS, Director of the Duke Surgical Vitreoretinal Fellowship Program and Professor of Ophthalmology, Pediatrics, and Biomedical Engineering with Tenure at Duke University Eye Center. “The Phase 2/3 study of OCU410ST is thoughtfully designed with scientific rigor and a patient-centered focus to evaluate both structural and functional outcomes. We are optimistic that this approach will move us closer to a meaningful therapeutic solution for affected families.”
The OCU410ST Phase 2/3 pivotal confirmatory trial represents a major advancement as Ocugen’s second late-stage clinical program. Ocugen plans to submit a BLA for OCU410ST in 2027 in alignment with its strategic goal of filing three BLAs over the next three years.
About OCU410ST OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR-Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathophysiological pathways linked to Stargardt disease, such as lipofuscin formation, oxidative stress, complement formation, inflammation, and cell survival networks.
About Stargardt Disease Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.
Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.
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 Thispressreleasecontainsforward-lookingstatementswithinthemeaningofThePrivateSecuritiesLitigationReformActof1995,including,butnot limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,whicharesubjecttorisksanduncertainties.Wemay,insomecases,usetermssuchas “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,butnotlimitedto,therisksthatpreliminary,interimandtop-lineclinicaltrialresultsmaynotbeindicativeof,andmaydifferfrom,finalclinical data;the ability of OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data;thatunfavorablenewclinicaltrialdatamayemergeinongoingclinicaltrialsorthroughfurtheranalysesofexistingclinicaltrialdata;thatearlier non-clinicalandclinicaldataandtestingofmaynotbepredictiveoftheresultsorsuccessoflaterclinicaltrials;andthatthatclinicaltrialdataare subject to differing interpretations and assessments, including by regulatory authorities.Theseandotherrisksanduncertaintiesaremorefully describedinourperiodicfilingswiththeSecuritiesandExchangeCommission(SEC),includingtheriskfactorsdescribedinthesectionentitled“Risk Factors”inthequarterlyandannualreportsthatwefilewiththeSEC.Anyforward-lookingstatementsthatwemakeinthispressreleasespeakonlyas ofthedateofthispressrelease.Exceptasrequiredbylaw,weassumenoobligationtoupdateforward-lookingstatementscontainedinthispress release whether as a result of new information, future events, or otherwise, after the date of this press release.
TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and durable activity in treating fibromyalgia: FDA PDUFA goal date of August 15, 2025
TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of reduction in fibromyalgia pain in two double-blind randomized placebo-controlled Phase 3 studies
If approved by FDA, TNX-102 SL would become the first member of a new class of non-opioid analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years
CHATHAM, N.J., June 16, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company) presented data in a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2025, held June 11-14, 2025, in Barcelona, Spain. A copy of the Company’s poster, titled “Advancing Fibromyalgia Treatment: Transmucosal Sublingual Cyclobenzaprine (TNX-102 SL) Targets Non-restorative Sleep and Provides Sustained Pain Reduction” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com. TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is a non-opioid analgesic designed for daily bedtime dosing with an FDA Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025.
“Fibromyalgia is a complex and invisible chronic pain condition which drives many patients to be prescribed chronic opioids which are associated with addiction and overdose,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “To address the chronic symptoms of fibromyalgia, potential therapeutic options must provide durable benefits. TNX-102 SL has shown statistically significant, durable activity (14 weeks) in reducing fibromyalgia pain in two Phase 3 studies. Designed to target the sleep disturbance of fibromyalgia, TNX-102 SL harnesses the therapeutic activity of cyclobenzaprine in part by reducing in the level of the active metabolite norcyclobenzaprine relative to oral cyclobenzaprine. Norcyclobenzaprine is believed to interfere with the durability of oral cyclobenzaprine’s treatment effect in off-label chronic dosing regimens and in a failed double-blind randomized placebo-controlled trial.1 TNX-102 SL now has the potential to be the first new treatment option for fibromyalgia patients in 15 years.”
TNX-102 SL is designed for transmucosal absorption to bypass first-pass hepatic metabolism. The poster presentation shows the day 20 steady state blood levels from a study of nightly TNX-102 SL dosing in which the peak level of cyclobenzaprine exceeds the level of the active metabolite norcyclobenzaprine during sleep time. In contrast, with nightly oral cyclobenzaprine dosing, pharmacokinetic simulations show that norcyclobenzaprine accumulates to higher levels, and the cyclobenzaprine peak level does not exceed the norcyclobenzaprine level during sleep time.
The poster includes data from the RESILIENT Phase 3 study evaluating the efficacy and safety of TNX-102 SL with a primary endpoint of reducing daily pain numeric rating scale scores after 14 weeks of treatment. TNX-102 SL significantly reduced pain and improved clinical outcomes in fibromyalgia patients while demonstrating a favorable tolerability profile. TNX-102 SL employs a novel mechanism targeting the sleep disturbance in fibromyalgia by acting as a potent antagonist at four post-synaptic receptors, each of which is known to regulate sleep.
About Fibromyalgia
Fibromyalgia is a common chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system, called central sensitization. Brain imaging studies have localized the functional disorder to the brain’s insula and anterior cingulate cortex. Fibromyalgia afflicts more than 10 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including depression, anxiety, headaches and abdominal pain or cramps. Individuals suffering from fibromyalgia often struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. Fibromyalgia is now recognized as the prototypic nociplastic syndrome. Nociplastic pain is the third primary type of pain in addition to nociceptive pain and neuropathic pain. Many patients present with pain syndromes that are mixtures of the three primary types of pain. Nociplastic syndromes are associated with central and peripheral sensitization. Fibromyalgia can occur without any identifiable precipitating event. However, many fibromyalgia cases follow one or more precipitating event(s) including: post-operative pain, acute or chronic nociceptive or neuropathic pain states; recovery from an infectious illness; a cancer diagnosis or cancer treatment; a metabolic or endocrine stress; or a traumatic event. In the cases of recovery from an infectious illness, fibromyalgia is considered an Infection-Associated Chronic Condition. In addition to fibromyalgia cases associated with other conditions or stressors, the U.S. National Academies of Sciences, Engineering, and Medicine, has concluded that fibromyalgia is a diagnosable condition that can occur after recovery from COVID-19 in the context of Long COVID.
About TNX-102 SL
TNX-102 SL is a centrally acting, non-opioid investigational drug, designed for chronic use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for bedtime dosing for the management of fibromyalgia. Cyclobenzaprine potently binds and acts as an antagonist at four different post-synaptic neuroreceptor subtypes: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors. Together, these interactions are believed to target the non-restorative sleep characteristic of fibromyalgia identified by Professor Harvey Moldofsky in 1975. Cyclobenzaprine is not associated with risk of addiction or dependence. The TNX-102 SL tablet is based on a eutectic formulation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine by the transmucosal route efficiently into the bloodstream. The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. Patents based on TNX-102 SL’s eutectic composition and its properties have issued in the U.S., E.U., Japan, China and many other jurisdictions around the world and provide market protection into 2034. The European Patent Office’s Opposition Division maintained Tonix’s European Patent EP 2 968 992 in unamended form after an Opposition was filed against it by a Sandoz subsidiary, Hexal AG. Hexal AG did not appeal that decision. The formulation of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, while reducing the risk of daytime somnolence. Clinical pharmacokinetic studies indicated that relative to oral cyclobenzaprine, TNX-102 SL results in higher levels of exposure during the first 2 hours after dosing and in deceased levels of the long-lived active metabolite, norcyclobenzaprine in both single dose and multiple dose studies, consistent with bypassing first pass hepatic metabolism. Cyclobenzaprine is a tertiary amine tricyclic and its active metabolite norcyclobenzaprine is a secondary amine tricyclic. At steady state after 20 days of dosing TNX-102 SL, the dynamic peak level of cyclobenzaprine is higher than the background level of norcyclobenzaprine during sleep time. In contrast, after 20 days of dosing oral cyclobenzaprine, the simulated peak level of cyclobenzaprine is lower than the simulated background level of norcyclobenzaprine.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* 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.
1Carette S, et al. Arthritis Rheum. 1994;37(1):32-40.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. 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 obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; 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 Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. 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.
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Key Points: – Supernus to acquire Sage for up to $12.00 per share, combining upfront cash and milestone-based CVRs. – Deal adds FDA-approved ZURZUVAE® for postpartum depression to Supernus’ growing CNS portfolio. – Transaction expected to be accretive by 2026, with $200M in annual cost synergies forecast.
Supernus Pharmaceuticals (NASDAQ: SUPN) has announced a strategic acquisition of Sage Therapeutics (NASDAQ: SAGE) in a deal worth up to $795 million, signaling a bold expansion into the neuropsychiatric space. This all-cash transaction, set to close in Q3 2025, brings to Supernus a key commercial asset—ZURZUVAE® (zuranolone)—as well as access to Sage’s central nervous system (CNS) discovery platform.
The proposed deal includes an upfront payment of $8.50 per share in cash, representing approximately $561 million, and a non-tradable contingent value right (CVR) worth up to an additional $3.50 per share. The CVR milestones are tied to commercial performance of ZURZUVAE in the U.S. and its future launch in Japan.
This acquisition is a transformative step for Supernus, best known for CNS products such as Qelbree®, GOCOVRI®, and ONAPGO™. With the addition of ZURZUVAE—the first and only FDA-approved oral treatment for postpartum depression—the company further solidifies its footprint in the growing neuropsychiatry market. Supernus CEO Jack Khattar stated that the move “adds a fourth growth product” and “diversifies our sources of future growth.”
ZURZUVAE was developed by Sage and commercialized in partnership with Biogen. Under the collaboration, Supernus will recognize revenue equal to 50% of U.S. net sales. In 2024, that share amounted to $36.1 million, with $13.8 million already reported in Q1 2025—indicating an accelerating ramp that Supernus is now positioned to capitalize on.
From a financial perspective, the deal is expected to be significantly accretive starting in 2026, supported by estimated annual cost synergies of up to $200 million. Supernus will fund the transaction entirely through its existing cash reserves, avoiding equity dilution or new debt issuance. For investors, this adds a layer of financial discipline and long-term earnings potential.
Sage’s leadership, including CEO Barry Greene, called the deal the result of a comprehensive strategic review aimed at maximizing shareholder value. Greene highlighted the company’s mission in brain health and praised the Sage team’s work in delivering two first-in-class therapies for postpartum depression.
In terms of integration, Sage’s R&D pipeline and commercial operations will fold into Supernus’ existing infrastructure—a move expected to streamline costs and accelerate product development. The combined entity will also benefit from a strengthened CNS platform and expanded market reach.
While the deal is subject to customary closing conditions, including regulatory approvals and a majority tender of Sage’s outstanding shares, both companies anticipate a smooth closing process. Supernus plans to provide revised financial guidance following deal completion in Q3.
This acquisition reflects a strategic shift in mid-cap biopharma, where clinical differentiation and near-term revenue growth are prioritized. For small- and micro-cap investors, it also signals continued consolidation in the CNS space—where innovation, reimbursement potential, and strong commercialization strategy drive M&A activity.
Mr. Hunter brings more than 40 years of experience building and leading commercial organizations in the biopharmaceutical industry, including leadership roles at Validus Pharmaceuticals, Relialab and Novartis
Led launch of Tonix Medicines, acquisition of migraine assets Zembrace® SymTouch® and Tosymra®, and recruitment of commercial leadership team
Appointment strengthens commercial strategy and governance as Tonix prepares for potential launch of TNX-102 SL for fibromyalgia this year
CHATHAM, N.J., June 13, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced the appointment of James “Jim” Hunter to its Board of Directors, effective June 12, 2025. Mr. Hunter most recently served as Executive Vice President, Commercial at Tonix, where he was responsible for building the Company’s commercial subsidiary, Tonix Medicines, and successfully executing its entry into the migraine market.
“Jim’s appointment to our Board comes at a pivotal moment as we continue to expand our commercial footprint and intensify our pre-commercial efforts for the potential launch of TNX-102 SL for fibromyalgia later this year,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Having successfully built Tonix Medicines from the ground up, Jim brings a unique operational perspective and deep commercial expertise that will be invaluable as we advance our commercial strategy and long-term growth.”
In his role as Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and President of Tonix Medicines from June 2023 to December 2024, Mr. Hunter was responsible for managing all aspects of Tonix’s commercial efforts, including sales, marketing, market access and other operational and strategic initiatives. In addition to its ongoing commercial activities with respect Tosymra and Zembrace, Tonix Medicines is actively involved in TNX-SL 102 pre-launch activities including launch strategy, market analysis, product positioning, and market access initiatives.
Previously, Mr. Hunter was CEO and Co-founder of Validus Pharmaceuticals from 2007 to 2018, where he was responsible for more than two dozen successful product acquisitions from companies such as Shire, Roche, Novartis and Sanofi. Jim was also Co-Founder of Relialab, a diagnostics company focused on CLIA-waived, point-of-care psychiatric testing. Prior to these ventures, Mr. Hunter was Executive Director of Neuroscience Sales at Novartis Pharmaceuticals, where he launched and supported products in schizophrenia, epilepsy, migraine, Parkinson’s and Alzheimer’s. Mr. Hunter also served as Executive Director of the Northeast Business Unit at Ciba Geigy Pharmaceuticals, where he was responsible for the General Practice and hospital sales force and Regional Managed Care. Mr. Hunter received his B.S. at Seton Hall University and earned his M.B.A at Fairleigh Dickinson University.
“I’m honored to join Tonix’s Board at such an exciting juncture,” said Mr. Hunter. “It’s been a privilege to help build Tonix Medicines and launch the Company’s commercial capabilities. I look forward to continuing to support Tonix’s mission as a member of the Board and contributing to its next phase of growth.”
“I’m grateful to Jim for creating and building our commercial department which has positioned us well to launch TNX-102 SL for the management of fibromyalgia,” said Thomas Englese, EVP of Commercial Operations and leader of Tonix Medicines. “Jim’s continued strategic involvement as we prepare for the launch and continue to build our commercial infrastructure will be incredibly valuable.”
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* 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. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. 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 obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; 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 Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. 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.
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
