Fulgent Genetics is accelerating its transformation into a comprehensive precision diagnostics platform with the announced acquisition of selected assets of Bako Diagnostics and the full acquisition of StrataDx in a combined transaction valued at approximately $55.5 million. The deal, which will be funded entirely with cash on hand, is expected to close in the first half of 2026, subject to customary regulatory approvals.
The acquisition marks a strategic expansion of Fulgent’s laboratory services business, adding anatomic pathology services, proprietary PCR-based molecular tests, and a significantly broader national client base. Together, Bako Diagnostics and StrataDx bring deep expertise in specialty pathology and dermatopathology, positioning Fulgent to meaningfully strengthen its diagnostic offerings across multiple clinical touchpoints.
Bako Diagnostics, headquartered in Alpharetta, Georgia, is a premier national provider of specialty laboratory testing with a comprehensive menu that includes anatomic pathology, molecular genetic testing, and peripheral neuropathy immunohistochemical analysis. StrataDx, based in Lexington, Massachusetts, is a leading dermatopathology laboratory serving providers nationwide with advanced diagnostics for skin diseases, including melanocytic lesions, lymphomas, and complex dermatoses. Both laboratories are CLIA-certified, CAP-accredited, and licensed in their respective states.
Strategically, the transaction aligns closely with Fulgent’s long-term vision of becoming a one-stop diagnostic partner across the healthcare continuum. One of the most compelling aspects of the deal is the opportunity to apply Fulgent’s existing investments in digital pathology and artificial intelligence to Bako’s and StrataDx’s operations. Fulgent has already developed proprietary tools such as Eziopath, an image management system designed to enhance workflow efficiency, turnaround time, and diagnostic quality. Integrating these technologies is expected to increase capacity while maintaining high clinical standards.
The acquisition also significantly expands Fulgent’s test menu. Bako’s proprietary PCR assays offer faster turnaround times and cost efficiencies, strengthening Fulgent’s competitive position in molecular diagnostics. Combined with StrataDx’s dermatopathology expertise, the expanded portfolio allows Fulgent to serve a wider range of clinicians and patients with more comprehensive diagnostic solutions.
Commercial synergies represent another major driver of the transaction. Bako’s nationwide sales organization will nearly double the size of Fulgent’s pathology-focused sales team, immediately extending its commercial reach. The expanded client base creates additional opportunities to cross-sell existing Fulgent services, deepen payer relationships, and increase access to covered lives through managed care contracts.
Geographically, the acquisition enhances Fulgent’s laboratory footprint with additional certified facilities in Georgia and Massachusetts, including New York State–approved labs. This broader presence improves logistical efficiency and positions the company for future growth in regulated markets.
Ming Hsieh, Chairman and CEO of Fulgent Genetics, emphasized the strategic fit of the deal, highlighting the company’s ability to layer new pathology services onto a rapidly growing laboratory platform while leveraging AI to drive efficiency and quality. Bako and StrataDx leadership echoed that sentiment, pointing to the benefits of combining specialized diagnostic expertise with Fulgent’s technology-driven infrastructure.
As healthcare increasingly shifts toward precision medicine, Fulgent’s acquisition of Bako Diagnostics and StrataDx represents a calculated step toward scale, integration, and long-term growth in advanced diagnostics.
CAMBRIDGE, Mass., Dec. 22, 2025 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today reported completion of the safety analysis from its proof-of-concept Phase 2, randomized, double-blind, placebo-controlled NST-AD-001 study of PrimeC combination in Alzheimer’s disease.
The safety analysis indicated a favorable tolerability profile for PrimeC. No serious adverse events were reported, and no new or unexpected safety signals were identified.
As an exploratory proof-of-concept study, clinical outcome measures are descriptive by design. NeuroSense will analyze clinical observations alongside biomarker data to enable a more comprehensive interpretation of the clinical observations, with results expected in the first quarter of 2026.
About Alzheimer’s Disease
Alzheimer’s disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting more than 30 million people globally. AD is characterized by memory loss, cognitive decline, and behavioral changes, and currently has no cure. Existing therapies provide only limited symptomatic relief, leaving a significant unmet need for disease-modifying treatments that can slow or halt progression. Given the complexity of AD, approaches that target multiple disease mechanisms simultaneously, such as PrimeC, hold potential to deliver meaningful therapeutic advances for patients and their families.
About PrimeC
PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.
About NeuroSense
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.
Forward-Looking Statements
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of regulatory filings, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding the timing of the reporting of additional data from the study of PrimeC in Alzheimer’s disease, are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Data Reported From the Open-Label Arm Of The FLAMINGO Trial Greenwich LifeSciences announced preliminary Phase 3 results from the open-label, non-HLA-A*02arm of its FLAMINGO-01 trial. The data showed a reduction in breast cancer recurrence rates of about 80% for patients that completed the primary vaccination series (PIS) ofGLSI-100. In addition, the first patient has completed the full 3-year treatment.
FLAMINGO0-01 Divides Patients By Immune Classification. The FLAMINGO-01 trial divides patients by their HLA types, a system of classifying a patient’s immune response. Patients with the most common HLA type, HLA-A*02, have enter one of the double-blind placebo-controlled arms of the trial. About 250 patients with other HLA types have been entered into an open-label portion, referred to as non-HLA-A*02.
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Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Cadrenal Continues Build Its Anticoagulation Pipeline. Cadrenal has acquired VLX-1005, a platelet inhibitor from Veralox Therapeutics, adding another novel small-molecule anti-coagulant to its pipeline. VLX-1005 is a selective inhibitor of 12-LOX, an enzyme that initiates a signaling pathway for platelet-mediated inflammation and leads to heparin induced thrombocytopenia (HIT). VLX-1005 has Orphan Drug Designation from the FDA and EMA.
VLX-1005 Has Completed A Phase 2 Clinical Trial. Two Phase 1 studies showed safety and tolerability, followed by a Phase 2 trial in patients with suspected heparin induced thrombocytopenia (HIT). Interim results to date showed reductions in thromboembolic events.
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Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Phase 3 FLAMINGO-01 Trial Reaches Enrollment Milestone. Greenwich Pharmaceuticals has completed enrollment in the open-label arm (non HLA-A*2 patients) in the Phase 3 FLAMINGO-01 trial, its trial testing GLSI-100 for prevention of breast cancer recurrence in high-risk patients. The patients are stratified according to their HLA (human leukocyte antigen) types, immune system characteristics that classify an individual’s potential response to antigens. Over 1,000 patients have been screened for the trial at over 140 clinical sites in the US and Europe.
Greenwich Pharmaceuticals Presented At the NobleCon21 Conference. CEO Snehal Patel spoke at the annual NobleCon21 conference. He presented a brief summary of GLSI-100 and the clinical trial, followed by a fireside chat discussion, and questions from the audience. To listen to the presentation, click here.
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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.
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Plans For MVA Vaccine and Gedeptin Trial Expectations Confirmed. GeoVax reported a 3Q25 loss of $6.3 million or $(0.31) per share, a smaller loss than the $8.0 million loss we had projected. The company reviewed several developments related to the Geo-MVA vaccine for smallpox/Mpox, Gedeptin, and CM04S1. Discussions for possible marketing collaborations continue. The cash balance on September 30, 2025 was $5.0 million.
Moving Forward With Geo-MVA. As discussed in our Research Note on June 17, the Geo-MVA vaccine for smallpox/Mpox is moving forward toward a Phase 3 trial. This follows receipt of Scientific Advice EMA (European Medicines Agency) stating that a marketing approval application can be submitted after a single, Phase 3 immuno-bridging study against the approved MVA vaccine. Phase 1 and Phase 2 would not be required. This saves several years and many millions dollars, allowing the company to sell the vaccine sooner.
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Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Phase 2 BESTOW Trial Data Reported. On Thursday evening, November 6, the results of the Phase 2 BESTOW trial in kidney transplant patients were presented. The trial did not meet its primary endpoint of tegoprubart superiority to the control arm but showed improvements in several important endpoints. We believe tegoprubart performed well and that the sharp decline in stock price is unwarranted.
Design Of The Phase 2 BESTOW Trial. The trial enrolled 126 patients into and randomized them into two arms. The first received tegoprubart and the second received tacrolimus, the standard of care, as a control arm. The primary endpoint was a difference in eGFR, a measure of kidney filtration and function. Additional endpoints reported were for the iBOX composite and measures of adverse events.
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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.
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Ocugen Reports 3Q25 With Milestones For FY2026. Ocugen reported a 3Q25 loss of $20.1 million or $(0.07) per share and gave updates on its clinical programs. Importantly, all three clinical trials are meeting or beating our expectations for progress toward the BLA filings. We continue to expect “3 filings in 3 years”, with the first approval in mid-2027.
OCU400 Expected To Start Rolling BLA Filing In 1H26. OCU400 received RMAT designation from the FDA, allowing portions of the BLA to be submitted as they are completed rather than waiting to submit the entire BLA at once. The non-clinical portions are planned for submission in early 2026, with clinical trial data submitted in 4Q26. This should start the FDA review earlier and allow for approval in mid-2027.
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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.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Unicycive Expects To Resubmit Its Application Before YE2025. Unicycive announced plans to resubmit its application for OLC (oxylanthanum carbonate) approval before the end of 2025. This follows a meeting with the FDA to identify and resolve issues that resulted in the Complete Response Letter (CRL) in June 2025. This timeframe is consistent with our expectations for resubmission. We continue to expect OLC to be approved by mid-2026.
Resubmission Announcement Follows An FDA Meeting. In early June 2025, Unicycive announced that a manufacturing inspection found deficiencies at a contract manufacturer’s facility. These inspections were one of the last steps toward approval of the New Drug Application (NDA), but the findings stopped the review process. Following the announcement, the company received a CRL on its PDUFA date of June 30, 2025.
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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.
Swiss pharmaceutical giant Novartis AG announced plans to acquire Avidity Biosciences for approximately $12 billion in cash, a move aimed at deepening its focus on rare and neuromuscular diseases while navigating an increasingly complex U.S. trade and regulatory landscape.
Under the terms of the agreement, Avidity shareholders will receive $72 per share, representing a 46% premium to the company’s most recent closing price. The acquisition, expected to close later this year pending regulatory approval, underscores Novartis’ aggressive strategy to expand its biotech capabilities and offset upcoming patent expirations on several of its blockbuster therapies.
The deal also includes the formation of a new spin-off company, Spinco, which will house Avidity’s early-stage precision cardiology programs. Spinco is expected to operate as an independent, publicly traded firm, led by Avidity’s current Chief Program Officer, Kathleen Gallagher.
Headquartered in San Diego, Avidity Biosciences has gained attention for pioneering a new class of RNA-based therapeutics that directly target muscle tissue. Its lead candidate, Del-zota, is being developed to treat a rare subtype of Duchenne muscular dystrophy (DMD), a debilitating genetic disorder that leads to progressive muscle weakness. Avidity is also advancing two other promising treatments for serious neuromuscular diseases, all of which leverage its proprietary antibody oligonucleotide conjugate (AOC) platform.
For Novartis, this acquisition offers a timely expansion into rare disease treatments — a sector experiencing growing investor interest due to high unmet medical needs and favorable regulatory incentives. The move is consistent with Novartis’ 2024 acquisition of Kate Therapeutics, another biotech developing gene therapies for muscle diseases, as well as its 2025 deals with Anthos Therapeutics and Regulus Therapeutics, collectively strengthening its position in genetic and cardiovascular medicine.
The rare disease market has become an increasingly competitive frontier for pharmaceutical innovation. Analysts note that Novartis’ acquisition spree is partly driven by its looming patent cliff, as flagship drugs such as Entresto, Xolair, and Cosentyx approach the end of their exclusivity periods. By acquiring companies like Avidity, Novartis not only diversifies its revenue base but also positions itself at the forefront of next-generation therapeutics that could define the next decade of biotech innovation.
The acquisition also carries strategic geopolitical undertones. With the Trump administration imposing 39% tariffs on Switzerland earlier this year, Swiss-based pharmaceutical companies face heightened uncertainty over U.S. trade policy. Expanding operations through American biotech acquisitions helps Novartis maintain a strong U.S. presence and mitigate risks tied to international tariffs.
For small-cap investors, the transaction reinforces an ongoing trend in the life sciences sector: large-cap pharma companies are increasingly looking to buy innovation rather than build it in-house. Early-stage biotech firms with validated technologies, particularly in RNA, gene therapy, and rare disease research, continue to attract premium valuations in acquisition deals.
Ultimately, Novartis’ acquisition of Avidity Biosciences is more than just a growth strategy — it’s a signal of where the pharmaceutical industry is heading. With advances in RNA therapeutics and genetic medicine accelerating, investors can expect more high-value takeovers in the months ahead as established players race to secure the next generation of life-changing treatments.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Proprietary Technology & Drug Design. James Martin, Chief Financial Officer and Co-CEO, participated in Noble’s Virtual Emerging Growth Conference on October 8th & 9th. The discussion focused on the company’s core technology to design antiviral compounds that bind to highly conserved, essential areas of the viral replication machinery, as well as progress updates on the product pipeline.The full video may be viewed here.
Lead Program & Near-Term Catalyst In Norovirus. The company’s most advanced program is CDI-988, an oral drug for norovirus. This lead indication was chosen strategically because there are no approved vaccines or therapeutics for norovirus. The market is significant, with a stated $60 billion annual market opportunity.
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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.
CHATHAM, N.J., Sept. 18, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced the successful completion of a Type B Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of TNX-102 SL (sublingual cyclobenzaprine HCl) for the treatment of major depressive disorder (MDD). The Company received positive feedback from the FDA and plans to pursue a supplemental new drug application (sNDA) to expand the therapeutic indication of TNX-102 SL to include MDD, based on exploratory findings suggesting that improving sleep quality may positively impact depressive symptoms.
“We are pleased with the outcome of our Pre-IND meeting with the FDA and appreciate their thoughtful guidance,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “This marks a significant step forward in our efforts to develop TNX-102 SL as a novel treatment for MDD, a condition that affects millions and remains underserved by current therapies that are often difficult to tolerate.”
“We believe bedtime TNX-102 SL has the potential to be a first-in-class treatment that is designed to target the reduced quality and quantity of slow wave sleep associated with depression,” said Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “TNX-102 SL is a tertiary amine tricyclic that is designed for transmucosal absorption to bypass first pass hepatic metabolism. In contrast, FDA-approved tertiary amine tricyclic antidepressants are swallowed pill formulations, that are largely metabolized by first-pass to longer-lived secondary amine tricyclics. Also, the FDA-approved tertiary amine tricyclic antidepressants are only active in treating MDD at more than ten times the dose employed with TNX-102 SL and can adversely impact weight, blood pressure, cognition, and sexual function.”
The FDA provided constructive feedback during the Pre-IND meeting for TNX-102 SL in MDD and found the proposed long-term safety data collection plan generally reasonable, potentially streamlining the development path.
An IND filing is planned for Q4 2025, positioning the program to enter Phase 2 clinical trials shortly thereafter. TNX-102 SL is FDA approved for the treatment of fibromyalgia, under the brand name Tonmya™. In the Phase 3 RESILIENT study of fibromyalgia patients, the TNX-102 SL – treated group had activity on improving depression over placebo by the Beck Depression Inventory (BDI), with an uncorrected p-value < 0.05. The biological relationship between depressed symptoms in fibromyalgia and those in MDD is not understood.
About TNX-102 SL TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride that enables rapid transmucosal absorption and reduces production of the long half-life active metabolite, norcyclobenzaprine, by bypassing first-pass hepatic metabolism. As a tertiary amine tricyclic (TAT) and multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. It is currently approved in the U.S. as a once-daily bedtime treatment for fibromyalgia in adults. TNX-102 SL is also in development as a daily bedtime treatment for acute stress reaction/acute stress disorder. Tonix also holds active IND’s for the following indications for TNX-102 SL: Long COVID (post-acute sequelae of COVID-19), PTSD, alcohol use disorder, and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10357465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary composition. These patents are expected to provide Tonmya with U.S. market exclusivity until 2034. Pending patent applications related to method of use could extend exclusivity until 2044.
Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix recently received FDA approval for Tonmya™, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology and infectious diseases. TNX-102 SL is 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’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.
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 successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully launch and commercialize Tonmya and any of our approved 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.
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.
(GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the expansion of FLAMINGO-01 clinical trial to Ireland.
The Company’s application to European regulators has been formally approved, adding Ireland as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, and the US.
According to the latest data collected by the European Cancer Information System (click here), a total of 3,723 new cases of breast cancer were diagnosed in Ireland in 2022, which is the most common cancer diagnosed in women, representing approximately 30% of all cancers in women. Breast cancer is the 2nd leading cause of death from cancer in women in Ireland with 883 deaths in 2022.
The Company is collaborating with Dr. Janice Walshe, who will be serving as the national principal investigator in Ireland for FLAMINGO-01. She is a key member of Cancer Trials Ireland research group ensuring access to novel agents and research opportunities for Irish women affected by breast cancer. Through the clinical research clinic in St Vincent’s University Hospital in Dublin, Ireland, she has served as national principal investigator for many important international trials in breast cancer. She served as a three-year member of ASCO Scientific Program Committee in triple negative breast cancer from 2013-2015. Her research has been presented at numerous international meetings and published in prestigious peer reviewed journals.
CEO Snehal Patel commented, “We have visited St. Vincent’s multiple times over the past few years, once to present GP2 and FLAMINGO-01 at their conference and most recently to train the study team. We have also been approached by Irish breast cancer patients who wish to participate in FLAMINGO -01 and who can now be considered for enrollment through the Dublin site.”
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
Investor & Public Relations Contact for Greenwich LifeSciences Dave Gentry RedChip Companies Inc. Office: 1-800-RED CHIP (733 2447) Email: dave@redchip.com
