CERRITOS, Calif., Oct. 22, 2025 (GLOBE NEWSWIRE) — The Oncology Institute, Inc. (“TOI”) (NASDAQ: TOI), a pioneer in value-based community oncology care, today announced that the company will release its third quarter 2025 financial results after the market close on Thursday, November 13, 2025, to be followed by a conference call the same day at 5:00 p.m. (Eastern Time).
The conference call can be accessed live over the phone by dialing 1-877-407-0789 or for international callers, 1-201-689-8562. A replay will be available two hours after the call and can be accessed by dialing 1-844-512-2921, or for international callers, 1-412-317-6671. The passcode for the live call and the replay is 13756737. The replay will be available until Thursday, November 20, 2025.
Interested investors and other parties may also listen to a simultaneous webcast of the conference call by logging onto the Investor Relations section of the Company’s website at https://investors.theoncologyinstitute.com/.
About The Oncology Institute
Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better.
On October 22, 2025, Alkermes plc (Nasdaq: ALKS) and Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced a definitive merger agreement reflecting a major shift in the sleep medicine sector and the broader biopharmaceutical industry. The all-cash transaction, valued at up to $20 per Avadel share, comprises an $18.50 cash payment plus a contingent value right (CVR) for an additional $1.50 per share linked to final FDA approval of LUMRYZ™ for idiopathic hypersomnia. This structure represents a transaction value of approximately $2.1 billion and a 38% premium to Avadel’s three-month average share price, indicating strong confidence in Avadel’s commercial prospects.
The acquisition marks Alkermes’ strategic expansion into the sleep medicine market—a key area of growth for the company. With this move, Alkermes augments its existing neuroscience and rare disease franchise by adding Avadel’s FDA-approved LUMRYZ™ (sodium oxybate), a once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in narcoleptic patients aged seven and older. LUMRYZ™ distinguishes itself as the market’s only once-nightly oxybate, offering significant convenience and competitive advantage over the twice-nightly alternative. Since its 2023 launch, LUMRYZ™ has experienced rapid adoption, with over 3,100 patients on therapy as of June 2025 and new patient starts outpacing competitors more than two-to-one. Net revenues are projected between $265–275 million for 2025, backed by a U.S. narcolepsy market of over 50,000 eligible patients.
Alkermes’ acquisition is expected to be immediately accretive to earnings and profit margins, providing the scale and financial strength to accelerate both commercial and clinical development programs. For Alkermes, the deal offers a robust foundation to support its late-stage developmental pipeline, specifically its orexin 2 receptor agonist candidates—alixorexton, ALKS 4510 and ALKS 7290—for narcolepsy and idiopathic hypersomnia. The combined company harnesses both organizations’ commercial expertise and operational infrastructure, streamlining R&D and driving cost synergies.
Leadership at both Alkermes and Avadel have expressed optimism about the transaction. Alkermes’ CEO Richard Pops described the acquisition as “a pivotal step” in the company’s evolution—a move that bolsters Alkermes’ entry into sleep medicine as it prepares to advance alixorexton into phase 3 trials. Avadel’s CEO, Greg Divis, characterized the merger as a validation of Avadel’s strategy, highlighting the differentiated value of LUMRYZ™ and the company’s dedication to sleep disorder patients.
Under the transaction’s terms, Alkermes will fund the acquisition with cash on hand and new debt, subject to regulatory and shareholder approvals. Both boards have unanimously approved the deal, targeting a closing date in the first quarter of 2026. Financial and legal advising teams include J.P. Morgan, Morgan Stanley, Goldman Sachs, Paul Weiss, and Cleary Gottlieb.
With this acquisition, Alkermes solidifies its position as a leader in neurological and sleep disorder treatments, accelerating the pace of innovation in a space with significant unmet patient needs. The combined organization is set to pursue further label expansions for LUMRYZ™, bring new therapies to market, and deliver increased value to shareholders and patients alike.
The landmark agreement between Alkermes and Avadel Pharmaceuticals underscores the accelerating consolidation trend within the life sciences sector, where innovative therapies and commercial scale are driving strategic acquisitions. The addition of LUMRYZ™ to Alkermes’ portfolio not only diversifies its product base but strengthens its market position in a segment characterized by high unmet medical need and strong growth potential.
Alkermes’ entry into the sleep medicine market will leverage Avadel’s proven commercial infrastructure and rare disease expertise, enabling more efficient launches and access for future products. The transaction also sets the stage for Alkermes to explore global expansion opportunities for LUMRYZ™ and other pipeline assets, while supporting additional indications such as idiopathic hypersomnia and leveraging Avadel’s salt-free, once-at-bedtime oxybate candidate.
As the two organizations integrate, operational synergies are expected to improve profitability and streamline R&D processes for advancing both existing therapies and new clinical programs. The merger, backed by reputable financial advisors and committed financing, represents a pivotal moment for stakeholders, positioning Alkermes as an emerging leader in neurology and sleep disorder therapeutics with a stronger foundation for future innovation and patient impact.
CERRITOS, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) — The Oncology Institute (NASDAQ: TOI), a pioneer in value-based community oncology care, today announced that Dr. Daniel Virnich, Chief Executive Officer, and Rob Carter, Chief Financial Officer, will participate in the Noble Capital Markets Emerging Growth Virtual Equity Conference, on October 8, 2025, including a presentation at 11:00am ET.
Interested parties can access a webcast of the presentation by registering at the link listed on the Investor Relations section of the Company’s websites at https://investors.theoncologyinstitute.com/.
Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better.
CERRITOS, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) — The Oncology Institute (NASDAQ: TOI), a pioneer in value-based community oncology care, is pleased to announce a new partnership with Protocol Behavioral Health, a leading provider of evidence-based mental health care for cancer patients. This collaboration underscores TOI’s commitment to delivering whole-person care by integrating behavioral health services directly into the cancer care journey.
Research shows that approximately 30% of cancer patients experience significant depression or anxiety, and oncologists widely agree that behavioral health support can benefit nearly every patient. Through this partnership, TOI patients will gain timely access to mental health services that are tailored specifically to the emotional and psychological challenges of cancer, with no waitlists and full integration into the patient’s care team, and the added benefit of services offered in multiple languages to support our diverse patient population.
“Anxiety and depression can greatly threaten a patient’s outcome by affecting their ability to complete treatment in the recommended time,” said Yale Podnos, MD, Chief Medical Officer at The Oncology Institute. “By embedding behavioral health services directly into our care model, we’re closing a critical gap in oncology and ensuring our patients have access to the support they need, exactly when they need it.”
Key Benefits of the Partnership:
Integrated Care Delivery: Protocol clinicians collaborate with TOI providers using the Collaborative Care Model (CoCM), an evidence-based framework proven to improve outcomes through team-based care.
Improved Access: Patients receive behavioral health support without delays, removing a major barrier to care in traditional mental health systems.
Specialized Expertise: Protocol’s behavioral health care managers and psychiatric providers are trained specifically to support oncology patients through diagnosis, treatment, survivorship, and beyond.
Improved Patient Outcomes: Studies link integrated behavioral health care to better treatment adherence, quality of life, and patient satisfaction.
“We founded Protocol to meet a clear need in oncology,” said Cara Bohon, PhD, Chief Clinical Officer of Protocol Behavioral Health. “Through this partnership, we’re ensuring that mental health care is not a luxury or an afterthought; it’s a core part of the patient’s treatment plan from day one.”
Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better.
Protocol Behavioral Health provides timely, evidence-based mental health care tailored to the unique needs of cancer patients. Using the Collaborative Care Model, Protocol integrates behavioral health managers and psychiatric providers directly into oncology care teams. This model ensures seamless coordination, personalized support, and better outcomes for patients experiencing depression, anxiety, and other behavioral health challenges.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
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Milestone in Findhelp partnership. SelectQuote announced that it has referred more than 200,000 low-income seniors to Findhelp, with nearly 50,000 of those individuals accessing free or reduced-cost services. The milestone demonstrates SelectQuote’s role in addressing the needs of Medicare-eligible consumers.
Partnership connects consumers to critical support. Findhelp is a closed-loop referral management software platform that connects individuals with community resources such as food, housing, transportation, and financial aid. SelectQuote has partnered with Findhelp for several years, directing seniors to assistance programs. The initiative does not generate revenue, but it extends SelectQuote’s Medicare distribution model by providing tangible value to consumers.
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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.
Pfizer Inc. (NYSE: PFE) has announced plans to acquire Metsera, Inc. (NASDAQ: MTSR), a clinical-stage biopharmaceutical company developing next-generation obesity and cardiometabolic treatments. The all-cash deal, valued at $47.50 per share, represents an enterprise value of approximately $4.9 billion, with the potential for an additional $22.50 per share in contingent milestone payments tied to clinical and regulatory approvals.
The acquisition marks Pfizer’s most significant push yet into the rapidly growing obesity treatment market, an area forecasted to reach hundreds of billions in value globally over the coming decade. With over 200 health conditions linked to obesity, pharmaceutical companies are racing to develop therapies that offer stronger efficacy, fewer side effects, and more convenient dosing schedules.
Metsera brings to Pfizer a diverse pipeline of incretin and amylin programs, including both injectable and oral formulations designed to improve weight loss outcomes. Its lead candidates include:
MET-097i, a weekly and monthly injectable GLP-1 receptor agonist currently in Phase 2 trials.
MET-233i, a monthly amylin analog in Phase 1 development, being tested both as monotherapy and in combination with MET-097i.
Two oral GLP-1 receptor agonist candidates expected to begin clinical trials in the near term.
Additional preclinical nutrient-stimulated hormone therapeutics under development.
Preliminary clinical data for MET-233i presented at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) indicated a potentially best-in-class profile, with strong durability and tolerability supporting less frequent injections.
Pfizer expects to leverage its global clinical, manufacturing, and commercial infrastructure to accelerate the development of Metsera’s portfolio. The acquisition aligns with the company’s broader strategy of expanding into high-growth therapeutic areas where demand is accelerating.
Under the agreement, Metsera shareholders will receive $47.50 in cash upon closing, with the possibility of an additional $22.50 per share through contingent value rights (CVRs). These CVRs include:
$5 per share upon the initiation of a Phase 3 trial for the MET-097i + MET-233i combination.
$7 per share upon U.S. FDA approval of MET-097i as a monthly monotherapy.
$10.50 per share upon FDA approval of the monthly MET-097i + MET-233i combination.
If all milestones are achieved, the transaction value could exceed $7 billion.
The deal has been unanimously approved by both companies’ boards of directors and is expected to close in the fourth quarter of 2025, subject to regulatory approval and shareholder consent.
With this acquisition, Pfizer joins competitors such as Eli Lilly and Novo Nordisk in intensifying the race to dominate the obesity treatment market. By combining Metsera’s innovative science with Pfizer’s scale, the company aims to deliver next-generation weight management solutions to millions of patients worldwide.
Practice earns maximum quality points on avoidable ED visits and admissions, saving more than $3,500 per episode
CERRITOS, Calif., Sept. 22, 2025 (GLOBE NEWSWIRE) — The Oncology Institute of Hope and Innovation (NASDAQ: TOI), a leading value-based oncology practice, achieved $1.1 million in Medicare savings during Performance Period 2 of the Centers for Medicare & Medicaid Services’ Enhancing Oncology Model (EOM) through its California professional corporation, with savings equating to more than $3,500 per patient episode. TOI earned the maximum score on avoidable emergency department visits and hospital admissions. Results were driven by our High Value Cancer Care program conducted by Health Care Coaches and 24/7 symptom management support that helped patients stay on treatment and out of the hospital.
EOM is a voluntary total-cost-of-care model created by the CMS Innovation Center to advance high-quality, person-centered, and equitable cancer care for Medicare Fee-for-Service beneficiaries.
“These results again prove that our proactive navigation and real-time symptom management reduce unnecessary hospital visits and keep patients on treatment,” said Dr. Yale D. Podnos, Chief Medical Officer and President of Practice. “Patients across all our markets have access to these proven best practices to ensure each patient receives the right care at the right time.”
“This performance reinforces TOI’s leadership in value-based oncology,” said Dan Virnich, Chief Executive Officer. “By delivering measurable savings while improving quality, we continue to demonstrate that high-value cancer care is both clinically superior and financially sustainable.”
TOI’s success in EOM builds on its track record in CMS’s prior Oncology Care Model, where the organization exceeded quality standards and generated multi-million-dollar savings for Medicare.
About The Oncology Institute (www.theoncologyinstitute.com): Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better.
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
OCU400 Licensing Completed. Ocugen has announced the completion of a licensing agreement for Korea with Kwangdong Pharmaceutical, Co., Ltd., a diversified pharmaceutical company in the Republic of South Korea. This finalizes the term sheet announced in August with the 2Q25 business update. We have based our revenue expectations on US and Europe, with the Korea agreement adding additional cash upon the signing and downstream royalties.
Agreement Provides Cash, Milestones, and Royalties. The terms provide Ocugen with signing and near-term milestones of $7.5 million. Under the agreement, Ocugen will manufacture and supply OCU400 in exchange for a royalty of 25% of Net Sales plus sales milestones of $1 million for every $15 million in Net Sales, or roughly 32% per $15 million in sales. There are an estimated 7,000 retinitis pigmentosa (RP) patients in Korea, with an estimated market of about $180 million over the first 10 years of sales. We estimate these potential payments at about $65 million to Ocugen.
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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.
Swiss pharmaceutical leader Roche has announced an agreement to acquire clinical-stage biopharmaceutical company 89bio, Inc. in a deal valued at up to $3.5 billion. The acquisition is set to strengthen Roche’s cardiovascular, renal, and metabolism portfolio, particularly its capabilities in treating metabolic dysfunction-associated steatohepatitis (MASH).
Under the terms of the agreement, 89bio shareholders will receive $14.50 per share in cash at closing, along with a non-tradeable contingent value right (CVR) providing up to an additional $6.00 per share contingent on specific milestones. The CVR payments are linked to the commercial success and sales performance of 89bio’s lead candidate, pegozafermin, a novel fibroblast growth factor 21 (FGF21) analog designed for patients with moderate to severe MASH and severe hypertriglyceridemia.
Pegozafermin is currently in Phase 3 clinical trials and is engineered to provide extended biological activity through a proprietary glycoPEGylated technology. The therapy aims to address critical unmet medical needs in liver and cardiometabolic diseases, including patients with advanced fibrosis and compensated cirrhosis. Its potential best-in-disease profile makes it a significant addition to Roche’s portfolio, enhancing the company’s efforts to provide innovative treatment options to patients worldwide.
The contingent payments under the CVR are structured to reward milestone achievements, including the first commercial sale of pegozafermin in F4 MASH cirrhotic patients, and annual global sales thresholds of $3 billion and $4 billion in subsequent years. This structure aligns shareholder incentives with the commercial success of the therapy while reflecting the high growth potential of 89bio’s pipeline.
The acquisition is subject to customary closing conditions, including the tender of a majority of 89bio’s outstanding shares and regulatory approvals. Roche plans to complete the transaction in the fourth quarter of 2025, after which 89bio will become part of Roche’s Pharmaceuticals Division. Until the closing, 89bio will continue to operate independently, maintaining its focus on the development of innovative therapies for liver and cardiometabolic diseases.
Financial advisors for 89bio include Moelis & Company LLC and Centerview Partners LLC, with Gibson, Dunn & Crutcher LLP serving as legal counsel. Citi and Sidley Austin LLP act as Roche’s financial and legal advisors.
The acquisition positions Roche to potentially transform the standard of care for patients with metabolic liver diseases while leveraging 89bio’s advanced clinical pipeline. Analysts view the deal as a strategic move to capture emerging opportunities in high-growth therapeutics, combining 89bio’s innovative platform with Roche’s global development, manufacturing, and commercialization capabilities.
$4.7 million upfront with up to an additional approximately $8.3 million of potential aggregate gross proceeds upon the exercise in full of warrants
BOTHELL, Wash., Sept. 15, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc., (Nasdaq: COCP) (the “Company” or “Cocrystal”), today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase and sale of 2,764,710 shares of its common stock at a purchase price of $1.70 per share. In a concurrent private placement, the Company issued unregistered warrants to purchase up to 5,529,420 shares of common stock at an exercise price of $1.50 per share that are exercisable upon issuance and will expire twenty-four months from the effective date of the registration statement covering the resale of the shares of common stock issuable upon exercise of the unregistered warrants.
H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.
The gross proceeds to the Company from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, were approximately $4.7 million. The potential additional gross proceeds to the Company from the warrants, if fully-exercised on a cash basis, will be approximately $8.3 million. No assurance can be given that any of such short-term warrants will be exercised. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.
The common stock (but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) described above were offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-271883) that was declared effective by the Securities and Exchange Commission (the “SEC”) on May 26, 2023. The offering of the shares of common stock was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering were filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained 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 placements@hcwco.com.
The unregistered warrants described above were 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.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, 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 the registration or qualification under the securities laws of any such state or other jurisdiction.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.
Forward-Looking Statements
The information in this press release includes “forward-looking statements.” Any statements other than statements of historical fact contained herein, including statements as to the intended use of net proceeds from the offering, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “could”, “might”, “plan”, “possible”, “project”, “strive”, “budget”, “forecast”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Cadrenal Acquires Complimentary Cardiovascular Products. Cadrenal announced that it has acquired the anti-coagulant assets of eXlthera Pharmaceuticals. The products include frunexian, a Pre-Phase-2 anti-coagulant drug that inhibits a different step in the coagulation cascade from tecarfarin. Frunexian is in development for different indications and could extend Cadrenal’s product line to additional indications that are not served by current drugs. The acquisition also includes an oral formulation and other research-stage molecules.
Frunexian Has Several Distinguishing Features. The lead product from eXlthera is frunexian, a Factor XIa inhibitor. Most of the DOAC (direct-acting oral anticoagulant) class target Factor Xa and have been developed for long-term use on an outpatient basis. In contrast, frunexian targets Factor XIa, a different component of the coagulation cascade.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
AVERSA Fentanyl Is Moving Forward. Nutriband reported results from 2Q26, ended July 31, 2025, with a loss of $2.12 per share. Revenues for 2Q26 were $0.6 million compared with $0.4 million in 2Q25. The increase was attributed to the expansion of contract manufacturing services in the Pocono Pharma division that produces kinesiology tape. Net loss was $2.0 million before Preferred Dividends of $21.8 million, bringing Net Loss Available To Shareholders to $23.8 million. Cash at the end of the quarter was $6.9 million.
Meeting With The FDA Later In September. The company has scheduled a meeting with the FDA on September 18, 2025, to discuss the upcoming Phase 1 clinical trial for AVERSA Fentanyl. This is a Type C Meeting, requested by the company to discuss product development. The meeting agenda includes the CMC (Chemistry, Manufacturing, and Controls) and other aspects of the Investigational New Drug Application (IND) using the 505(b)(2) route of regulatory approval.
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.
