ORLANDO, Fla., Feb. 17, 2026 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ: NTRB) (NASDAQ: NTRBW) today announced that it has signed an exclusive distribution agreement with Costa Rica Based Innomedica for AVERSA Fentanyl upon approval and all sports tape products manufactured at its Pocono Pharmaceutical / Active Intell subsidiary. Innomedica will also be overseeing and financing all regulatory approvals for the above mentioned products as they ramp up for launch.
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, including opioids and stimulant drugs, 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.
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 periodic and current reports on Form 10-K, Forms 10-Q and 8-K 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.
Company Highlights GEO-MVA Manufacturing Readiness and Clear Clinical Pathway to Support Global Supply Diversification
ATLANTA, GA – February 17, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today issued a statement endorsing the urgent call to action articulated by Rosamund Lewis, MD (WHO Head, Poxviruses Programme) and colleagues in their recently published PLOS Medicine article, “The mpox epidemic is not over: Reducing disproportionate burden in Africa and persistent global risk require a sustained response.” (https://journals.plos.org/plosmedicine/article/file?id=10.1371/journal.pmed.1004893&type=printable)
The article underscores that, despite declining attention in some regions, mpox transmission, morbidity, and mortality continue, particularly across Africa, driven by evolving viral clades, constrained vaccine supply, and persistent inequities in access to countermeasures. Dr. Lewis reinforced these concerns in a recent public call to action, emphasizing that sustained political will, financing, and expanded vaccine availability remain essential to controlling mpox as a global health threat.
“GeoVax strongly endorses Dr. Lewis’s message that the mpox epidemic is not over and that complacency would be a costly mistake,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “The data are clear: mpox continues to circulate, evolve, and disproportionately impact vulnerable populations. A durable response requires sustained investment, diversified vaccine supply, and readiness that extends beyond reactive surge manufacturing.”
GEO-MVA: Advancing Toward an Expanded Global MVA Vaccine Supply
GeoVax’s GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine for the prevention of mpox and smallpox, is being developed specifically to help address the structural vulnerabilities highlighted in the PLOS Medicine analysis – most notably the world’s continued dependence on a single manufacturer for licensed MVA vaccine supply.
Key GEO-MVA program milestones include:
Completion of GEO-MVA clinical material, positioning the program for late-stage clinical execution and supply readiness
Planned initiation of a pivotal Phase 3 immunobridging study in Q4 2026, aligned with formal Scientific Advice from the European Medicines Agency supporting an expedited registration pathway
Anticipated availability of immunobridging results in Q2 2027, supporting potential regulatory submissions and procurement discussions
“With a clearly defined regulatory pathway ahead, GEO-MVA is transitioning from preparedness planning to execution,” Dodd added. “This program is designed not only to meet regulatory requirements, but to support long-term global readiness by expanding MVA vaccine capacity in a market that remains chronically supply-constrained.”
Sustained Preparedness Requires Sustained Supply
The PLOS Medicine authors emphasize that mpox will continue to pose a global risk due to ongoing zoonotic spillover, viral evolution, and efficient transmission networks, particularly in settings where health systems are under-resourced. GeoVax believes these realities reinforce the need for redundant, geographically diversified MVA manufacturing capacity – a principle that underpins the GEO-MVA program.
“As the mpox response evolves from emergency reaction to long-term control, vaccine supply resilience becomes a cornerstone of preparedness,” said Dodd. “GeoVax is committed to supporting that objective by advancing GEO-MVA as an additional MVA vaccine option for public-health and biodefense stakeholders worldwide.”
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) 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, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: 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.
ATLANTA, GA, February 13, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX) (the “Company”), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it has entered into definitive agreements for the purchase and sale of 432,902 shares of its common stock (or pre-funded warrants in lieu thereof) at a purchase price of $2.31 per share (or pre-funded warrant in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules (the “Offering”). In a concurrent private placement, the Company will issue unregistered series A-1 warrants to purchase up to 432,902 shares of common stock and unregistered series A-2 warrants to purchase up to 432,902 shares of common stock. The warrants will have an exercise price of $2.31 per share and will be exercisable beginning on the effective date of shareholder approval of the issuance of the shares of common stock upon exercise of the warrants. The series A-1 warrants will expire five years after the date of shareholder approval and the series A-2 warrants will expire two years after the date of shareholder approval.
The closing of the Offering is expected to occur on or about February 17, 2026, subject to the satisfaction of customary closing conditions. The gross proceeds from the Offering are expected to be approximately $1 million, before deducting placement agent fees and other estimated offering expenses. The Company intends to use the net proceeds from the Offering to advance its product candidates, including research and development, manufacturing, clinical studies, and working capital.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the Offering.
The shares (or pre-funded warrants) (but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) in the registered direct offering described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-277585) previously filed with the Securities and Exchange Commission (the ”SEC”) and declared effective by the SEC on March 13, 2024. The registered direct offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the registered direct offering that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at [email protected].
The unregistered warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
The Company also has agreed to amend certain existing warrants to purchase up to an aggregate of 236,000 shares of the Company’s common stock that were previously issued to the investors in July 2025, with an exercise price of $4.35 per share, respectively, effective upon the closing of the offering, such that the amended warrants will have a reduced exercise price of $2.31 per share and will be exercisable beginning on the effective date of shareholder approval of the issuance of the shares upon exercise of the warrants.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) 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, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans, including, but not limited to, statements regarding the completion of the offering, the satisfaction of customary closing conditions related to the offering, the receipt of shareholder approval and the anticipated use of proceeds from the offering. 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.
NORWOOD, Mass., Feb. 11, 2026 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed” or the “Company”) (CSE: MRMD) (OTCQX: MRMD), a leading cannabis consumer packaged goods company and retailer, announced today it will report its fourth quarter and full year 2025 financial results on March 11, 2026 after the markets close. Management will host a conference call on March 12, 2026 at 8:00 a.m. EDT to discuss financial results.
A webcast will be available and can be accessed via MariMed’s Investor Relations website at MariMed Q425 Earnings Webcast. A playback of the call will also be made available on MariMed’s Investor Relations website.
About MariMed MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, InHouse™, Nature’s Heritage™, and Vibations™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.
Company Contact: Howard Schacter Chief Communications Officer Email: [email protected] Phone: (781) 277-0007
DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
1Q26 Results. DLH reported revenue of $68.9 million, down from $90.8 million y-o-y, and modestly below our $70.1 million projection. The decline reflects the loss of certain programs to small business set-aside contractors. Adjusted EBITDA was $6.5 million versus our $6.2 million estimate. Net loss was $1.3 million, or a loss of $0.09/sh, versus our estimate of a loss of $1 million, or a loss of 0.07/sh.
Cost Scaling Initiatives. With the loss of the Head Start program and winding down of the CMOP contracts in 2026, DLH undertook some cost reduction measures in the first and second fiscal quarters to align expenses with current revenue volumes. We expect management to closely watch expenses until top line improvement returns.
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., Feb. 09, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the appointment of Rita Johnson-Greene as Chief Financial Officer (CFO).
“Mrs. Johnson-Greene’s diverse background across a variety of strategic roles at organizations representing many facets of the industry make her well-suited to serve as Ocugen’s CFO,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “We look forward to her leadership as we enter into a transformative time at Ocugen, beginning with the submission of the first of three Biologics License Applications (BLAs) this year.”
Mrs. Johnson-Greene has more than 20 years of healthcare experience. She most recently served as Chief Operating Officer at the Alliance for Regenerative Medicine (ARM) where she led ARM’s operations, finance, and global expansion initiatives to advance the development of engineered cell therapies and genetic medicines and promote access for all patients. Prior to her role at ARM, she was the Vice President of Sales and Qualified Treatment Centers (QTC) at Genetix Biotherapeutics (formerly known as bluebird bio), where she built and scaled pre-commercial U.S. sales and QTC operations teams to support the launch of the ZYNTEGLO™ and SKYSONA™ gene therapy brands. Mrs. Johnson-Greene also held senior leadership positions at Spark Therapeutics and supported the launch of LUXTURNA®. Previously, she held roles in finance, commercial operations, and sales in both North and South America for AstraZeneca. Mrs. Johnson-Greene began her career in strategic consulting with Accenture’s strategy practice.
“I am excited to join Ocugen and believe in the potential of the Company’s novel modifier gene therapy platform to address unmet medical needs that still exist for major blindness diseases,” said Mrs. Johnson-Greene. “Having been in the cell and gene therapy space for many years, I understand the unique business needs required to operate efficiently and drive future success.”
Mrs. Johnson-Greene earned her MBA in Finance and Strategic Management from The Wharton School at the University of Pennsylvania, and her undergraduate degree in Electrical Computer Engineering from Drexel University. She serves on the Drexel University Biomed Dean’s Executive Advisory Council and is a guest lecturer for biomedical graduate students.
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 [email protected]
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.
Fiscal Q2 results. SelectQuote reported fiscal Q2 revenue of $537.1 million, above our $520.0 million estimate, driven by stronger-than-expected Senior performance. Adj. EBITDA of $84.7 million exceeded our $82.0 million forecast, reflecting near-record 39% adj. EBITDA margins in Senior that more than offset pharmacy reimbursement pressure.
Medicare Advantage headwinds. Management cited pressure from a large national carrier’s decision to reduce strategic marketing spend across all channels. We believe this reflects a deliberate effort to moderate enrollment growth and protect plan profitability following above-trend member additions, rather than any deterioration in underlying demand.
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.
MustGrow’s Canola Field Trials Demonstrate Clubroot Disease Suppression; Improved Canola Yield with Heathier Root Systems
MustGrow’s mustard-derived organic biocontrol technology TerraMGTM focuses on soil-borne disease and pest suppression, which has been shown to improve soil conditions, crop yields, and healthier root systems;
Clubroot is a soil-borne parasitic disease with devastating effects on canola production across the Canadian Prairies with no effective products currently registered for Clubroot suppression;
Field trial findings support TerraMGTM’s role as a sustainable product capable of suppressing Clubroot and promoting higher canola yields and root systems under various disease pressures;
MustGrow (via NexusBioAg) trialed approx. 100 acres over 2-year field program.
SASKATOON, Saskatchewan, Canada, February 3, 2026 – MustGrow Biologics Corp. (TSXV: MGRO; OTC: MGROF; FRA: 0C0) (the “Company” or “MustGrow“), is pleased to announce completion and results of its 2-year field trial program in the Canadian Prairies on approximately 100 acres of canola production. Field trial findings have demonstrated MustGrow’s TerraMGTM is a sustainable technology capable of suppressing clubroot parasitic disease (P. brassicae) (“Clubroot”) and promoting higher canola yields and root systems under various disease pressures.
Clubroot is a soil-borne parasitic disease that has had devastating effects on canola production across the Canadian Prairies with no effective products currently available for Clubroot suppression. Canola is Canada’s most valuable field crop, with 2025 production reaching approximately $14 billion (21.8 million tonnes at approximately $650/tonne)(1) and generating billions in annual export revenue. Without adequate treatment and management solutions, Clubroot continues to create major problems for Canadian canola farmers who need a solution.
TerraMGTM: MustGrow’s Answer to Clubroot
MustGrow is actively working towards registering its organic biocontrol product TerraMGTM through Health Canada’s Pest Management Regulatory Agency. TerraMGTM combats Clubroot through its mechanism, releasing naturally occurring isothiocyanates from mustard seed meal. Isothiocyanates are known to possess fungicidal and biocidal activity, suppressing a range of soil-borne pathogens, including Clubroot.
In MustGrow’s 2024 and 2025 field trials, conducted through its wholly-owned Canadian marketing and distribution business NexusBioAg, TerraMGTM-treated plots showed a significant reduction in resting spore concentrations of Clubroot relative to untreated controls. Visual assessments of canola root galls indicated reduced severity and incidence in treated plots. These findings support TerraMGTM’s role as a sustainable biocontrol capable of suppressing Clubroot inoculum and promoting higher canola yields and healthier root systems under various disease pressure.
In 2024, Clubroot spores were more prevalent due to a wetter growing season, and TerraMGTM performed exceptionally well with up to 95% reductions in Clubroot spores. Disease pressure was consistent throughout the season due to the wetter conditions. Yield benefits to the grower showed up to a 7 bushel/acre increase (19% increase over Canada’s 36 bushel/acre average production in 2024)(2), translating to a $91/acre increase in value to the farmer (at approximately $13/bushel average commodity price)(3).
In 2025, according to internal data, canola farmers experienced a relatively dry season and correspondingly less Clubroot disease prevalence than the much wetter 2024 season. Yield increase utilizing TerraMGTM demonstrated a 1-2 bushel/acre increase over the control, which was less impactful than 2024, with less Clubroot infestation in the fields to address.
Detrimental Disease with Limited Options for Farmers
The 15-20 year longevity of Clubroot’s highly resilient resting spores is a key element of Clubroot’s persistence and detrimental impact on canola. The parasitic disease induces gall formation on roots, disrupting water and nutrient uptake. Early infection with moderate to high spore loads can lead to 100% loss of canola crop. Infection at the early seedling stage can later result in wilting, stunting, yellowing and death of canola plants. In later crop stages, inflection may not necessarily show wilting, stunting or yellowing, but infected plants may ripen prematurely, resulting in shriveled seeds and negatively impacting yield, oil content, and quality.(4)
No effective products are currently registered for Clubroot suppression in canola. Current farming practices include extensive sanitation and equipment cleaning, long crop rotations (3-4 years between canola crops), and genetically-modified resistant canola varieties. While genetic resistance in commercial canola hybrids initially provided strong control, new mutated Clubroot pathotypes are now capable of overcoming resistance.(4)
These methods, while partially effective, are economically and logistically challenging. A biological, soil-active technology, like MustGrow’s TerraMGTM, capable of reducing resting spore loads could represent a significant breakthrough in sustainable Clubroot management for Canadian farmers.
MustGrow Biologics Corp. is a fully-integrated provider of innovative biological and regenerative agriculture solutions designed to support sustainable farming. The Company’s proprietary and third-party product lines offer eco-friendly alternatives to restricted or banned synthetic chemicals and fertilizers. In North America, MustGrow offers a portfolio of third-party crop nutrition solutions, including micronutrients, nitrogen stabilizers, biostimulants, adjuvants and foliar products. These products are synergistically distributed alongside MustGrow’s wholly-owned proprietary products and technologies that are derived from mustard and developed into organic biocontrol and biofertility products to help replace banned or restricted synthetic chemicals and fertilizers. Outside of North America, MustGrow is focused on collaborating with agriculture companies, such as Bayer AG in Europe, the Middle East and Africa, to commercialize MustGrow’s wholly-owned proprietary products and technologies. The Company is dedicated to driving shareholder value through the commercialization and expansion of its intellectual property portfolio of approximately 110 patents that are currently issued and pending, and the sales and distribution of its proprietary and third-party product lines through NexusBioAg. MustGrow is a publicly traded company (TSXV-MGRO) and has approximately 62.9 million common shares issued and outstanding and 77.0 million shares fully diluted. For further details, please visit www.mustgrow.ca.
Contact Information
Corey Giasson Director & CEO Phone: +1-306-668-2652 [email protected]
MustGrow Forward-Looking Statements
Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.
Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Forward-looking statements in this news release, including statements about: the impact and significance of customer performance data and field testing, the increase in value of yields and the costs of such increase in value, if any, and are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include: those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2024 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available on SEDAR+ at www.sedarplus.ca. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.
Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Phase 1b Data For Second Year After Transplantation Presented. Eledon presented data from its Phase 1b trial at the American Society of Transplant Surgeons (ASTS) meeting in January 2026. The presentation included data from 8 patients that had reached 24 months after transplantation, compared with 12 patients evaluated 12 months after transplantation presented in August 2025. These new data show a continued improvement in kidney function during the second year.
New Data Show Durability With Improvements. The 24-month data shows eGFR in tegoprubart patients continued to improve during months 12 to 24 after transplantation. The eGFR levels were restored to normal levels within 1 month after transplantation and were maintained for up to 2 years. Although this is a small number of patients, we see the result as consistent with prior data and our expectations for organ survival.
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ORLANDO, Fla., Jan. 30, 2026 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ: NTRB) (NASDAQ: NTRBW) has provided an update to shareholders on the key milestones and discussions from this years Annual Shareholders Meeting, held on Jan 24, 2026 in Orlando, Florida. Details and highlights may be found below.
Addition of Two New Directors
Allesandro Puddu Alessandro Puddu is an Italian Chartered Accountant and Statutory Auditor with over 10 years of experience in audit, corporate advisory and financial reporting for industrial groups and listed companies.
He advises companies on tax and corporate matters, company valuations, extraordinary corporate transactions and IAS/IFRS reporting, including consolidated financial statements. He has supported the design and implementation of accounting and administrative procedures and regularly serves as statutory auditor and member of statutory boards of Italian companies.
He currently serves as Group Internal Auditor for a company listed on the STAR segment of the Italian Stock Exchange, overseeing internal control and audit activities, including those related to the Group’s United States subsidiaries. At the beginning of his career, he worked at PricewaterhouseCoopers as a Senior Auditor, reviewing Italian and multinational companies operating in various industrial sectors, including the pharmaceutical sector, and coordinating audit teams across multiple jurisdictions.
Alessandro Puddu is enrolled in the Italian Register of Chartered Accountants (Dottori Commercialisti), the Register of Statutory Auditors held by the Italian Ministry of Economy and Finance, and the Register of Crisis & Insolvency Practitioners, and holds a Master’s Degree in Economics and Management.
Viorica Carlig Viorica Carlig is a senior executive with over a decade of leadership experience across service-based companies. She currently provides executive and strategic oversight for multiple multinational organizations, leading operations, governance, compliance, budgeting, and growth initiatives in complex regulatory environments. With a background spanning business administration, law, and economics—including a Ph.D. in Economics—Viorica combines strong commercial judgment with rigorous operational and risk management expertise. Earlier in her career, she practiced commercial and corporate law as a member of the Bucharest Bar, advising companies on contracts, governance, and regulatory compliance. She is a multilingual leader experienced in managing diverse teams and stakeholders across Europe and beyond.
2025 AVERSA™ FENTANYL Development Summary
Strengthened collaboration with Kindeva for AVERSA™ FENTANYL through an exclusive product development partnership and long-term commitment based on shared development costs in exchange for milestone payments
Granted patent protecting its AVERSA™ abuse deterrent platform technology in Macao, a Special Administrative Region of the People’s Republic of China
Completed commercial manufacturing process scale-up with partner Kindeva for Aversa™ Fentanyl
Issued new US patent which further expands Nutriband’s intellectual property protection in the United States for its portfolio of abuse deterrent transdermal products
Held Type C meeting with US FDA to obtain feedback on the Chemistry, Manufacturing, and Controls plans for AVERSA™ FENTANYL through commercialization
Filed a new provisional patent application with the U.S. Patent and Trademark Office (USPTO) covering improved aversive formulations and coating application methods to enhance the abuse deterrent properties and further strengthen Nutriband’s intellectual property protection for its AVERSA™ technology
Initiated development of the worldwide commercial brand name and visual identity for AVERSA™ FENTANYL with Brand Institute, Inc.
2026 AVERSA™ FENTANYL Focus on Development Towards NDA Filing
File nonprovisional patent application to potentially extend patent protection of AVERSA™ technology-based products to 2046
Manufacture clinical supplies for the Human Abuse Liability (HAL) clinical trial
File Investigational New Drug (IND) application with the US FDA
Initiate Human Abuse Liability (HAL) clinical study
EarthVision Bio Purchase of Pocono Pharma
The full purchase price and closing for the proposed sale of our Pocono subsidiary has not been received as of the shareholder meeting on Jan 24, 2026. However, the Company is collecting on the agreed nonrefundable $10,000 USD weekly penalty and has so far collected $30,000 USD of payments to extend the closing date.
Company Complaint Filed with FINRA
The Company, has filed a complaint with the Financial Industry Regulatory Authority (FINRA) on behalf of our shareholders to look into suspected naked short selling. The information was collected and prepared with a specialist analyst in the area of naked short selling.
Warrant Expiration in 2026
The Company is reminding shareholders that the warrants issued in our uplisting to NASDAQ on October 1, 2021 will expire on October 1, 2026. Currently there are 91,0904 warrants set to expire with a strike price of $6.43 totaling $5,856,112 if exercised.
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, including opioids and stimulant drugs, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s periodic and current reports on Form 10-K, Forms 10-Q and 8-K 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.
TONMYA demonstrated significant reduction in fibromyalgia pain compared with placebo in the Phase 3 RESILIENT study
Unique sublingual formulation designed for bedtime dosing bypasses first-pass metabolism, optimizing parent-drug exposure during sleep and decreasing levels of the persistent active metabolite
Treatment was well tolerated with minimal effects on weight or blood pressure
CHATHAM, N.J., Jan. 30, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, presented data on TONMYA™, which was investigated as TNX-102 SL, at the 2026 Non-Opioid Pain Therapeutics Summit, on January 29, 2026, in Boston, Massachusetts. A copy of the Company’s presentation, titled “TNX-102 SL (Sublingual Cyclobenzaprine HCl): a Centrally Acting Non-Opioid Analgesic for the Treatment of Fibromyalgia,” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.
“Fibromyalgia is a chronic pain disorder affecting more than 10 million adults in the U.S., with existing treatments often limited by tolerability and side effects,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The data presented at the Non-Opioid Pain Therapeutics Summit by our Chief Medical Officer, Gregory Sullivan, M.D. highlight TONMYA’S role as a centrally-acting, differentiated non-opioid treatment. TONMYA’S unique sublingual formulation is designed for bedtime administration and to bypass first-pass metabolism, resulting in a pharmacokinetic profile that favors parent-drug exposure during sleep while limiting daytime exposure to the active metabolite. Since fibromyalgia patients are commonly prescribed opioids off-label, there is a clear need for effective non-opioid alternatives.”
The data presented at the Summit come from RESILIENT, a 14-week randomized, double-blind, placebo-controlled Phase 3 trial at 34 U.S. sites, with 456 intent-to-treat participants who met the 2016 American College of Rheumatology criteria for fibromyalgia. Participants received TONMYA or placebo administered sublingually at bedtime. Treatment with TONMYA resulted in a statistically significant reduction in weekly average pain scores at Week 14 (p<0.0001) versus placebo, with an effect size of 0.38. The study also demonstrated significant improvements in key secondary endpoints, including sleep disturbance (p<0.001), fatigue (p<0.001), and the Symptoms (p<0.001) and Function (p=0.001) domains of the Fibromyalgia Impact Questionnaire-Revised (p<0.001 for both). TONMYA was well tolerated, with minimal impact on weight and blood pressure, and a rate of adverse event-related discontinuations of 6.1% on TONMYA vs. 3.5% on placebo. The most common adverse events were mild and self-limited oral cavity reactions that rarely led to study withdrawal.
“TONMYA’S sublingual formulation largely bypasses first-pass hepatic metabolism, which reduces formation of norcyclobenzaprine, the persistent active metabolite that we believe otherwise interferes with the duration of the treatment effect,” said Dr. Sullivan. “This results in a distinct pharmacokinetic profile compared to oral cyclobenzaprine, with greater relative bioavailability of the parent drug during sleep and reduced active metabolite exposure during daytime. Bedtime sublingual administration is also designed to target the non-restorative sleep that is central to fibromyalgia pathophysiology, translating to broad-spectrum activity across the core symptoms of fibromyalgia, including pain, sleep disturbance, and fatigue, with a favorable tolerability profile that may reduce the need for polypharmacy.”
TONMYA was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults. It is the first new prescription medicine approved for fibromyalgia in more than 15 years.
Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix markets FDA-approved TONMYA™, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. TONMYA is the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. Tonix also markets two treatments for acute migraine in adults: Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray). Tonix’s development portfolio* is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a Phase 2- ready 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 rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study in 2026. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a Phase 2- ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease. Finally, 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, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality 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’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.
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. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially as a result of a number of factors, including the ability of the Company to satisfy the conditions to the closing of the offering and the timing thereof, as well as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 18, 2025, 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.
INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS TONMYA is contraindicated: In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
DRUG INTERACTIONS
MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information. To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Unicycive Announced FDA Acceptance Of The NDA. Unicycive announced FDA acceptance of its resubmission of the New Drug Application (NDA) for OLC (oxylanthanum citrate). The resubmitted application has been classified as a Class II complete response, with a six-month review period. June 29, 2026 is the new PDUFA date, the statutory date for the application to be answered. This is consistent with our expected timeframe for OLC approval and launch.
We See NDA Acceptance As A Significant Milestone. In June 2025, an FDA manufacturing inspection found compliance deficiencies at the facility of a contract manufacturer. This stopped the NDA approval process just weeks before the PDUFA (Prescription Drug User Fee Act) date of June 28, 2025. The review of the preclinical, clinical, safety, and manufacturing data had been completed. We believe this will result in prompt approval.
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FDA assigns Prescription Drug User Fee Act (PDUFA) target date of June 29, 2026
Ended 2025 with unaudited cash position of $41.3M with expected runway into 2027
LOS ALTOS, Calif., Jan. 29, 2026 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company’s investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The Agency has deemed the OLC resubmission to be a Class II complete response which has a six-month review period from the date of resubmission and set a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026.
“We are pleased that the agency has promptly accepted the resubmission of our NDA for OLC,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “We are advancing our commercial preparation activities in anticipation of a potential launch of OLC later this year, to help provide an important treatment option to patients with chronic kidney disease (CKD) on dialysis who continue to struggle with hyperphosphatemia.”
The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies as well as chemistry, manufacturing and controls (CMC) data. The FDA did not raise any concerns regarding OLC’s preclinical, clinical, or safety data included in the original NDA submission.
The Company ended 2025 with an unaudited position of $41.3 million in cash, cash equivalents, and short-term investments, which permits continued advancement of OLC commercial launch activities and a cash runway into 2027.
About Oxylanthanum Carbonate (OLC) OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden.
Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.1 Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
1Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145.
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 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.
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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; our need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to delays in obtaining or failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; and our failure, or the failure of our third-party manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, which could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
