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.
The evolving relationship between the Trump administration and major pharmaceutical giants like Pfizer and Eli Lilly is reshaping the U.S. biotech and pharmaceutical sectors in unexpected ways. As President Trump’s approach to drug pricing and distribution intensifies, investors are watching closely to see whether these changes will threaten Big Pharma’s profit margins—or set the stage for a new era of growth for smaller, more innovative companies.
One of the most notable policy shifts has been the Trump administration’s overt encouragement—or at least acceptance—of large pharmaceutical firms selling directly to consumers. This “TrumpRx” strategy is a radical departure from the conventional system involving intermediaries and pharmacy benefit managers. On one hand, such a model could potentially drive efficiency and lower costs for some patients. On the other hand, it stirs up considerable uncertainty about how much profit large firms like Pfizer and Eli Lilly can preserve in an environment where pricing pressure and regulatory scrutiny are rising.
For investors focused on the biotech sector, the uncertain impact on Big Pharma profits is neither an all-out negative nor a clear positive. Recent developments, including public negotiations between the Trump administration and pharmaceutical leaders, have left markets feeling neutral in their outlook. There’s a sense that the sector may finally be heading into a period of relative stability after years of headlines about aggressive price controls and disruptive policy threats.
But questions linger: If legislative and regulatory changes ultimately compress profit margins for giants like Pfizer and Eli Lilly, how much will these incumbents be willing to invest in breakthrough innovation? Big Pharma’s research budgets have long been a cornerstone of biotech progress, underwriting everything from gene therapies to next-generation cancer drugs. If these resources dwindle, will smaller players have to pick up the slack—or could this shift clear the runway for young, ambitious biotech companies to rise?
Some analysts argue that a direct-to-consumer environment and tighter financial discipline for industry leaders could empower small and mid-cap biotech firms. Unlike their larger rivals, these companies are often leaner, faster-moving, and more reliant on outside partnerships and licensing deals to bring new therapies to market. With Big Pharma potentially becoming more selective in its investments, nimble startups may find themselves with new opportunities to innovate, collaborate, and even become acquisition targets.
Ultimately, the Trump administration’s evolving stance toward pharmaceutical profits and the direct selling model may serve as a stabilizing force in the sector—at least in the short term. Investors will need to monitor how major policy decisions translate to bottom-line impacts, R&D spending, and future innovation. While uncertainty remains, the potential for small-cap biotech firms to thrive in the coming years has rarely looked more compelling. For patient investors, this environment could prove fertile ground for discovering the next generation of biotech trailblazers.
Minerva Neurosciences (Nasdaq: NERV) has put itself firmly back in the spotlight, announcing one of the largest small-cap biotech financings of 2025. The Massachusetts-based clinical-stage company will receive up to $200 million to fund a confirmatory Phase 3 trial and commercial launch preparation for roluperidone, a promising therapy targeting the often-overlooked negative symptoms in schizophrenia patients. The initial $80 million arrives up front, with further tranches contingent on study milestones, offering NERV investors rare clinical and regulatory visibility at a critical inflection point.
This private placement, due to close October 23, includes $80 million upfront through Series A Convertible Preferred Stock and up to $80 million more if Tranche A warrants are fully exercised, plus a potential $40 million linked to subsequent milestone events. The offering is led by Vivo Capital with support from several prominent healthcare investors, suggesting the market sees real value in roluperidone’s regulatory progress.
But unlike many small caps, which struggle with dilutive equity raises or uncertain funding, Minerva’s staged, milestone-driven deal structure means investors can track clinical and regulatory progress directly to additional capital inflows. Warrants are only unlocked if the trial meets its statistically significant 12-week endpoint, keeping capital efficiently aligned to risk.
Minerva has achieved a notable alignment with the FDA on its confirmatory trial protocol for roluperidone, targeting negative symptoms—a significant unmet need in schizophrenia treatment. Negative symptoms, such as social withdrawal or loss of motivation, often persist even with current antipsychotics, representing a billion-dollar market where no competitor is FDA-approved. Minerva’s confirmatory Phase 3 design will use a randomized double-blind, placebo-controlled format, tracking the PANSS Marder negative symptoms factor score as a primary endpoint over 12 weeks.
This clarity on regulatory requirements and a defined path for NDA resubmission is crucial for investors, lowering typical clinical-stage risk and increasing confidence in eventual market entry. The company has committed resources for trial expansion and is already preparing for a U.S. commercial launch, signaling an advanced state of readiness pending approval.
In addition to the funding, Minerva plans to strengthen its board with up to three new directors experienced in schizophrenia trials, further supporting robust clinical execution. Investors will also appoint a Scientific Advisory Board dedicated to trial oversight, ensuring best practices and direct accountability to stakeholders.
With shares already up over 150% for the year, Minerva now stakes its future on one pivotal readout. For small cap-focused investors, NERV offers rare transparency on trial financing, regulatory alignment, and near-term commercial prospects—key ingredients for outsized returns but also heightened binary risk typical of biotech.
As Minerva initiates its confirmatory Phase 3 trial and prepares for NDA resubmission, sector watchers will track not just headline efficacy results, but also enrollment metrics, board appointments, and potential warrant triggers. For investors tolerant of volatility and seeking direct exposure to major clinical milestones, Minerva’s fully funded path towards solving negative symptoms in schizophrenia could prove a defining bet in the 2025 biotech landscape.
NX-801 is a live virus vaccine investigational candidate, designed to provide durable protection against mpox and smallpox
TNX-801 demonstrated favorable safety, immunogenicity, and long-term protection in multiple preclinical models
Data support advancement of TNX-801 toward clinical development
CHATHAM, N.J., Oct. 17, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”) presented data in an oral presentation at the World Vaccine Congress–Europe 2025, held October 14–16, 2025, in Amsterdam, the Netherlands. A copy of the Company’s presentation, titled “Safety, Durability and Protection of a Single-Dose TNX-801 Mpox Vaccine,” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.
“Vaccines remain a cornerstone of pandemic preparedness and biodefense,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The data presented in Amsterdam support the potential of TNX-801 as a next-generation orthopoxvirus vaccine candidate with the ability to confer durable protection. We believe TNX-801 has the potential to strengthen global readiness for emerging and re-emerging poxvirus threats.”
TNX-801 is a live, attenuated, minimally replicative investigational vaccine candidate based on horsepox virus and is being developed to protect against mpox (monkeypox) and smallpox. Preclinical data presented by Sina Bavari, Ph.D., Executive Vice President, Infectious Disease Research at Tonix Pharmaceuticals, demonstrated that TNX-801 produced durable immune protection following a single dose and was well tolerated across multiple routes of administration, including percutaneous, subcutaneous, and intramuscular delivery. TNX-801 elicited strong neutralizing antibody responses and protected animals from clinical disease and mortality following mpox challenge in non-human primate, rabbit, and murine models. Immunogenicity and durability were observed for at least 14 months post-vaccination.
“We are encouraged by the consistency and durability of the TNX-801 data across multiple preclinical models,” said Dr. Sina Bavari. “We are also excited by the opportunity to evaluate microneedle patch technology as a novel delivery platform to simplify administration and expand vaccine accessibility in future development stages.”
About TNX-801* TNX-801 (recombinant horsepox virus) is an, attenuated, minimally replicative, live virus vaccine based on horsepox in pre-clinical development to prevent mpox and smallpox. Tonix reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge with monkeypox. After a single dose vaccination, TNX-801 prevented clinical disease and lesions and decreased shedding in the mouth and lungs of non-human primates. The findings are consistent with mucosal immunity and suggest the ability to block forward transmission, similar to Dr. Edward Jenner’s vaccine, which eradicated smallpox and kept mpox out of the human population. TNX-801 is based on synthesized horsepox which is believed to be more closely related to Dr. Jenner’s vaccine than 20th century vaccinia viruses. Smallpox vaccines descended from Jenner’s vaccine used prior to 1900 would be called horsepox by modern nomenclature.. Tonix has received official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-801 as a potential vaccine to protect against mpox disease and smallpox. Tonix has announced a collaboration with the Kenya Medical Research Institute (KEMRI) to design, plan and seek regulatory approval for a Phase I clinical study of TNX-801 in Kenya. The Company believes TNX-801 has the potential to make a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale, and the use of a lower dose than non-replicating vaccines. The FDA-approved non-replicating mpox vaccine Jynneos® requires two doses and provides a relatively short duration of protection. FDA also recently approved ACAM2000, a live, replicating vaccinia vaccine for prevention of mpox. ACAM200 is a clone from DryVax®, a 20th century vaccinia vaccine derived from the NYCBH strain. Pre-clinical results from an mRNA vaccine recently showed some protection from a Clade I monkeypox challenge, but with multiple break-through lesions in vaccinated animals.
Tonix Pharmaceuticals Holding Corp.* Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix has received FDA approval for TonmyaTM, 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, rare disease and infectious disease. 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). 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 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 rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a 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 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 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.
Conference call and webcast to discuss results to be held on November 7, 2025 at 8:00 a.m. ET
IRVINE, Calif., Oct. 17, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced an oral presentation will be featured at the American Society of Nephrology’s upcoming Kidney Week 2025 Annual Meeting taking place in Houston, TX, from November 5-8, 2025. The oral presentation will highlight topline results from the Phase 2 BESTOW trial evaluating tegoprubart for the prevention of rejection in kidney transplantation.
Details of the oral presentation are below:
Title: Efficacy and Safety of Tegoprubart for the Prevention of Rejection in Kidney Transplantation: Results from the Phase 2 BESTOW Trial Presenter: Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota; Executive Medical Director, Solid Organ Transplant Service Line, M Health Fairview Abstract Publication Number: TH-OR089 Session Title: Late-Breaking Research Orals – 1 Session Date and Time: November 6, 2025, from 4:30 p.m. to 6:00 p.m. CT Session Room: Grand Ballroom C (Convention Center) Presentation Time: 5:30 p.m. to 5:42 p.m. CT
Conference Call
Eledon will hold a conference call on November 7, 2025 at 8:00 a.m. Eastern Time to discuss the Phase 2 BESTOW trial results presented at Kidney Week. The dial-in numbers are 1-800-717-1738 for domestic callers and 1-646-307-1865 for international callers. The conference ID is 92427. A live webcast of the conference call will be available on the Investor Relations section of the Company’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
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Deal strengthens neuromodulation lineup with battery-free neurostimulation system
Boston Scientific Corporation (NYSE: BSX) announced Friday that it has entered into a definitive agreement to acquire Nalu Medical, Inc., a privately held medical technology company specializing in minimally invasive treatments for chronic pain.
Under the terms of the agreement, Boston Scientific will pay approximately $533 million in cash for the remaining equity of Nalu Medical that it does not already own. The company has been a strategic investor in Nalu since 2017. The transaction, expected to close in the first half of 2026, remains subject to customary closing conditions.
Nalu’s flagship product, the Nalu Neurostimulation System, is designed to deliver targeted relief for adults suffering from severe, intractable chronic pain of peripheral nerve origin — including pain in the shoulder, lower back, and knee. The system delivers mild electrical impulses to interrupt pain signals before they reach the brain and features a miniaturized, battery-free implantable pulse generator powered wirelessly by an external therapy disc and controlled via a smartphone app.
The U.S. Food and Drug Administration cleared the Nalu system in 2019. Results from the COMFORT and COMFORT 2 clinical trials demonstrated significant and sustained pain reduction, with 87% of participants in the first trial reporting more than 50% pain reduction at 12 months and 79% in the second trial achieving an average 64% reduction at six months. Real-world data from over 2,000 patients reinforced these outcomes, with 94% experiencing clinically meaningful improvement.
“Peripheral nerve stimulation is an exciting field with a significant unmet patient need,” said Jim Cassidy, president of Neuromodulation at Boston Scientific. “Adding Nalu Medical’s highly differentiated technology complements our existing therapies — including spinal cord stimulation, basivertebral nerve ablation, and radiofrequency ablation — and enables us to deliver advanced pain relief options to a wider variety of patient populations.”
Boston Scientific expects Nalu to generate over $60 million in sales in 2025 and to deliver growth exceeding 25% in 2026. The acquisition is projected to be immaterial to adjusted EPS in 2026, slightly accretive in 2027, and increasingly accretive thereafter. On a GAAP basis, the company expects the deal to be more dilutive due to amortization and acquisition-related expenses.
Nalu Medical, headquartered in Carlsbad, California, has been repeatedly recognized for innovation, including being named among the top 100 new products globally by R&D Magazine and winning multiple Medical Design Excellence Awards. Its compact, modular neurostimulation system represents a next-generation approach to chronic pain management by reducing the need for frequent interventions and improving patient comfort.
Boston Scientific, based in Marlborough, Massachusetts, is a global medical technology leader with a 45-year history of advancing science and developing solutions that improve patient outcomes across multiple therapeutic areas.
Massive trading volume follows dual announcements boosting balance sheet and strategic outlook
Rani Therapeutics Holdings (NASDAQ: RANI) surged more than 200% in early trading Friday, with over 240 million shares changing hands — a dramatic increase from its three-month average daily volume of just over 600,000. The spike follows back-to-back announcements of a major collaboration agreement with Chugai Pharmaceutical Co. worth up to $1.085 billion and an oversubscribed $60.3 million private placement.
The collaboration with Japan-based Chugai — a member of the Roche Group — covers multiple high-value therapeutic programs, including those in rare diseases and immunology. Under the deal, Rani will receive a $10 million upfront payment and is eligible for up to $75 million in technology transfer and development milestones, $100 million in sales milestones, and single-digit royalties on future product sales. Chugai also has the option to partner on up to five additional drug targets under similar terms, which could bring the total potential deal value to more than $1 billion.
“This partnership represents a convergence of Rani’s cutting-edge oral delivery platform and Chugai’s expertise in antibody development,” said Rani Therapeutics CEO Talat Imran. “We’re uniting two powerful scientific teams to develop oral therapies that could redefine treatment for rare and immunologic diseases globally.”
Alongside the collaboration, Rani announced a $60.3 million private placement priced at-the-market under Nasdaq rules, led by new investor Samsara and joined by RA Capital Management, Anomaly, Special Situations Funds, Invus, and Rani’s Executive Chairman Mir Imran. The oversubscribed financing includes 42.6 million shares of Class A common stock and 82.4 million pre-funded warrants, each accompanied by warrants to purchase additional shares.
Rani said the net proceeds from the offering, combined with the upfront and milestone payments from Chugai, will extend its operating runway into 2028 and fund advancement of its RaniPill® platform — a proprietary oral delivery system designed to replace subcutaneous or intravenous biologic injections with oral capsules.
“We believe this additional financing from leading biotech investors reflects growing confidence in our strategy,” said Imran. “Together, this financing and our strategic partnership with Chugai mark a pivotal moment for Rani.”
At the closing of the financing, Samsara and Anomaly will each have the right to appoint a member to Rani’s board of directors.
Rani Therapeutics, based in San Jose, California, is a clinical-stage biotherapeutics company focused on developing orally administered biologics and drugs using its RaniPill® platform technology.
Praxis Precision Medicines, Inc. (NASDAQ: PRAX) announced positive topline results from its Essential3 Phase 3 program evaluating ulixacaltamide HCl for the treatment of essential tremor (ET). The company reported that both pivotal studies met their pre-specified primary endpoints, with all key secondary endpoints also achieved, and ulixacaltamide was generally well tolerated with no drug-related serious adverse events.
In the parallel-group study (Study 1), patients treated with ulixacaltamide demonstrated a mean improvement of 4.3 points from baseline in the Modified Activities of Daily Living 11 (mADL11) at Week 8 (p<0.0001). All key secondary endpoints, including rate of disease improvement over 12 weeks, Patient Global Impression of Change (PGI-C), and Clinical Global Impression of Severity (CGI-S), were statistically significant (p<0.001).
In Study 2, a randomized-withdrawal design, patients maintained superior treatment effects on ulixacaltamide versus placebo (p=0.0369), with the first key secondary endpoint — rate of disease improvement — also demonstrating a statistically significant benefit (p=0.0042).
“Patients in the Essential3 program had been living with essential tremor for an average of 30 years, with worsening symptoms and no effective treatment options,” said Marcio Souza, President and CEO of Praxis Precision Medicines. “The strong results underscore the large unmet need for a therapy like ulixacaltamide. We look forward to discussing a potential NDA with the FDA in the near term.”
The Essential3 program enrolled over 700 patients across two studies using a decentralized design in the United States. Study 1 was a 12-week, double-blind, placebo-controlled trial evaluating change in mADL11 at Week 8. Study 2 enrolled stable responders to ulixacaltamide and assessed maintenance of effect during a four-week randomized-withdrawal phase.
Ulixacaltamide is a selective T-type calcium channel inhibitor designed to block abnormal neuronal burst firing in the Cerebello-Thalamo-Cortical circuit, which is associated with tremor activity. The therapy is the most advanced program in Praxis’ Cerebrum™ small molecule platform.
Essential tremor is the most common movement disorder in the U.S., affecting roughly 7 million people, and currently has limited treatment options. Propranolol is the only approved therapy, with limited efficacy and tolerability, leaving a substantial patient population untreated.
Following the announcement, PRAX shares surged more than 200% in early trading, with roughly 2.8 million shares traded, far exceeding the three-month daily average of 449,000 shares. Praxis has submitted a pre-NDA meeting request to the FDA and plans to continue advancing ulixacaltamide toward regulatory submission.
SAN DIEGO, Oct. 14, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that it will be presenting results from its positive Phase 3 clinical trial evaluating Hydronidone, a novel anti-fibrotic agent that inhibits hepatic stellate cell (HSC) activation and promotes HSC apoptosis, for the treatment of liver fibrosis in chronic hepatitis B, at The Liver Meeting® 2025, the annual meeting of the American Association for the Study of Liver Diseases (AASLD). The Liver Meeting® 2025 is being held November 7-10, 2025, in Washington D.C.
This abstract has been selected as a Poster of Distinction, and the details are below:
Title: Phase 3 Trial of Hydronidone for Liver Fibrosis in Chronic Hepatitis B
Presenting Author: Prof. Lungen Lu, M.D., Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Session: Hepatitis B (“1187-1367”)
Date/Time: Friday, November 7, 2025, 8:00 a.m. – 5:00 p.m. Eastern Time
Publication Number: 1121
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the United States. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY®, and development programs for F573, F528, and F230.
For Investors:
David Zhang Gyre Therapeutics david.zhang@gyretx.com
CHATHAM, N.J., Oct. 14, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated biotechnology company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, delivered a presentation titled “The History and Promise of anti-CD154 Monoclonal Antibody Immunomodulation for Transplantation,” at the 61st Annual Congress of the Japan Society for Transplantation, which took place October 9–11, 2025, in Nagoya, Japan. The CD40-ligand (CD40L) is also known as CD154. A copy of the Company’s presentation is available under the Presentations tab of the Tonix website at https://ir.tonixpharma.com/presentations.
“We are encouraged by the favorable safety and biomarker data from the Phase 1 study, which support the continued development of TNX-1500 as a novel immunomodulatory approach in transplantation and autoimmune diseases,” said Dr. Seth Lederman, Chief Executive Officer of Tonix Pharmaceuticals. “Dimeric TNX-1500 was designed to target cell-associated CD40L, which we believe plays important roles in organ rejection. We look forward to engaging further with the transplantation and immunology communities as we move into next-stage studies.”
Dr. Lederman added, “Several studies have shown that anti-CD40L treatment of animals with transplanted organs is associated with an increase in the number and activity of T-regulatory cells (“T regs”). We are excited that Mary Brunkow, Fred Ramsdell and Shimon Sakaguchi were awarded the Nobel Prize in Physiology or Medicine 2025 for the discovery and characterization of these T regs and their role in peripheral immune tolerance just a few days before the conference. The growing recognition of the significance of T regs in the immune response has driven our interest in pursuing anti-CD40L treatment to prevent organ transplant rejection.”
Dr. Lederman’s presentation highlighted his discovery of CD40L as a therapeutic target, the evolution of anti-CD40L therapeutic monoclonal antibodies and featured data from the completed Phase 1 study of TNX-1500, Tonix’s third-generation Fc-modified dimeric anti-CD40L monoclonal antibody. The talk reviewed the molecule’s design to minimize thromboembolic risk while maintaining immunomodulatory activity, presented Phase 1 safety and pharmacodynamic results, and outlined next steps toward Phase 2 development for the prevention of kidney transplant rejection and the treatment of autoimmune indications.
Dr. Lederman’s presentation was part of a morning breakfast seminar sponsored by Tonix and chaired by Professor Takaaki Kobayashi, from Aichi Medical University School of Medicine, that included presentations by two academic Tonix collaborators: a presentation by Harvard Professor and Massachusetts General Hospital (MGH) surgeon Richard Pierson III titled, “CD154/CD40 blockade with Fc-modified anti-CD154 mAb for heart transplantation” and a presentation by Harvard Professor and MGH surgeon Tatsuo Kawai titled, “CD154/CD40 blockade with Fc-modified anti-CD154 for kidney transplantation.”
About TNX-1500 TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that binds and functionally inhibits the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. Two published articles in the American Journal of Transplantation demonstrate TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in combination with other drugs in non-human primate renal and heart allografts.
*TNX-1500 is an investigational new biologic and is not approved for any indication
Tonix Pharmaceuticals Holding Corp.*
Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix has 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, rare disease and infectious disease. 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). 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 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 rare disease portfolio includes TNX-2900, intranasal potentiated oxytocin with magnesium, in development for Prader-Willi syndrome. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a 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 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 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.
CHICAGO, IL, Oct. 13, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 603,769 shares of common stock at a purchase price of $1.22 per share, in a private placement to accredited investors. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.52 per share, which price represents the “Minimum Price” as defined under NYSE American Rule 713 (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six-months following issuance and have a term of three years from the issuance date. The private placement is expected to close on or about October 15, 2025, subject to the satisfaction of customary closing conditions.
The gross proceeds from the offering are expected to be approximately $736,600, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering to fund the execution of Step 1 of Part C of the Phase II trial THIO-101 and for working capital.
The securities 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 the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the 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 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 the registration or qualification under the securities laws of any such state or other jurisdiction.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) completion of the private placement, (ii) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (iii) our ability to advance product candidates into, and successfully complete, clinical studies, (iv) the timing or likelihood of regulatory filings and approvals, (v) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (vi) the rate and degree of market acceptance of our product candidates, (vii) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (viii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries. Investor Relations Contact +1 (872) 270-3518 ir@maiabiotech.com
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
We Are Initiating Coverage of NeuroSense With An Outperform Rating. NeuroSense Therapeutics is developing therapies for degenerative neurological conditions. The lead product, PrimeC, has completed two Phase 2 trials for ALS (Amyotrophic Lateral Sclerosis) and has a Phase 3 trial planned for early 2026. Initial results from Phase 2 in Alzheimer’s disease has shown promising data. Our price target is $9 per share.
The Lead Indication For PrimeC Is in ALS. PrimeC is a novel formulation containing a combination of celecoxib and ciprofloxacin. These two drugs have been used separately for anti-inflammatory and anti-antimicrobial indications. After new data showed that each drug can affect pathways of degenerative disease, scientists at NeuroSense tested the two drugs together in models of ALS and found a synergistic effect. Two Phase 2 studies showed benefits on survival, disease progression, and biomarkers of ALS activity.
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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.
Move expected to strengthen BioCryst’s presence in hereditary angioedema and sustain double-digit growth trajectory
BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) has announced plans to acquire Astria Therapeutics, Inc. (NASDAQ: ATXS) in a cash-and-stock transaction valued at approximately $700 million in enterprise value, or about $920 million in aggregate equity value. The deal is designed to expand BioCryst’s hereditary angioedema (HAE) portfolio and enhance its long-term growth prospects.
Under the terms of the agreement, Astria shareholders will receive $8.55 in cash and 0.59 shares of BioCryst common stock for each Astria share. Based on BioCryst’s 20-day volume-weighted average price of $7.54 as of October 8, 2025, the consideration represents an implied value of $13.00 per Astria share, a 53% premium to Astria’s October 13 closing price and a 71% premium to its 20-day VWAP. The transaction, unanimously approved by both boards, is expected to close in the first quarter of 2026, subject to customary conditions. Upon completion, Astria CEO Jill C. Milne, Ph.D., will join the BioCryst board of directors.
The acquisition adds navenibart, Astria’s late-stage, long-acting monoclonal antibody inhibitor of plasma kallikrein, currently in Phase 3 clinical development for HAE prophylaxis. Navenibart’s extended dosing schedule—every three to six months—could offer patients a more convenient alternative to existing injectable treatments.
“With navenibart, BioCryst gains a perfectly complementary second product candidate that fits seamlessly within our HAE core competency,” said Jon Stonehouse, CEO of BioCryst. “Together with Orladeyo, we can offer patients both oral and injectable options that address diverse needs, while driving sustainable growth and profitability.”
The addition of navenibart positions BioCryst to broaden its presence in the rare-disease market. The company expects top-line data from the pivotal ALPHA-ORBIT trial in early 2027 and projects a commercial opportunity among more than 5,000 patients currently treated with injectable prophylaxis for HAE.
BioCryst will also acquire STAR-0310, Astria’s early-stage program for atopic dermatitis, though it plans to pursue strategic alternatives for that asset. Financially, the company anticipates that the transaction will maintain its non-GAAP profitability and positive cash flow, while providing meaningful synergies and accretion to operating profit in the first full year following navenibart’s expected launch. BioCryst projects Orladeyo sales of $580 million to $600 million in 2025, up 34% year-over-year in 2024, and expects the acquisition to reinforce a double-digit growth trajectory through the next decade.
