Clinical Data doubles known genetic factors associated with urate and Gout CALGARY, Alberta, Dec. 31, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease, highlights recent peer-reviewed, independent, published research reports that expand current knowledge that... Read more
USD 100 million senior term loan facility with a 2-year maturity
Strengthens liquidity to support execution across Alvotech’s R&D pipeline and global product launches through 2026
Led by GoldenTree Asset Management REYKJAVIK, Iceland, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced a USD 100 million senior... Read more
FDA issues Complete Response Letter (CRL) for resubmitted ONS-5010 BLA ISELIN, N.J., Dec. 31, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to the ONS-5010/LYTENAVA™ (bevacizumab-vikg) biologics license application... Read more
HOUSTON, Dec. 31, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced the filing of a Phase 1/2 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) seeking regulatory clearance... Read more
REDWOOD CITY, Calif. / Dec 31, 2025 / Business Wire / Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the U.S. Food and Drug Administration (FDA or the Agency) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA)... Read more
FDA grants AXS-05 Priority Review designation and sets PDUFA action goal date of April 30, 2026 NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (NDA) for AXS-05 (dextromethorphan HBr and... Read more
New Drug Application (NDA) submission on track for January 2026 NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) supporting an NDA submission for AXS-12 in narcolepsy. AXS-12 (reboxetine)... Read more
BioAtla will receive an initial $5 million for general operating and Phase 3 clinical trial expenses to advance Oz-V in 2L+ OPSCC with the remaining $35 million anticipated to close in Q1 2026.
BioAtla to retain 65% ownership of Oz-V across all solid tumor indications after completion of the SPV transaction.
BioAtla will lead Phase 3 trial execution for Oz-V in OPSCC through data readout for potential accelerated approval and enrollment anticipated to begin early 2026.
Oz-V... Read more
HALIFAX, NOVA SCOTIA / ACCESS Newswire / December 30, 2025 / MedMira Inc. (MedMira) (TSXV:MIR), reported today on its financial results for the quarter ended October 31, 2025.
Corporate update
In Q1 FY2026, the Company received the Health Canada approval for its Reveal® TP (Syphilis) rapid test. This major milestone allows the Company to offer the fastest rapid test approved in Canada to detect the antibodies against Syphilis. The aim is to provide a highly sensitive... Read more
WASHINGTON, Dec. 30, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved NEREUS™ (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion. This approval marks the first new pharmacologic treatment in motion sickness in over four decades, representing a significant advancement in the understanding and management of... Read more
If approved, DTX401 will be the first therapy approved to treat the underlying cause of GSDIa NOVATO, Calif., Dec. 30, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that it has completed the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), seeking approval for DTX401 AAV gene therapy (pariglasgene brecaparvovec) as a treatment for Glycogen Storage Disease Type Ia... Read more
SEATTLE, Dec. 30, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced it will be participating in the upcoming 44th Annual J.P. Morgan Healthcare Conference in San Francisco, CA.
Adaptive Biotechnologies’ management is scheduled to present on Monday, January 12, 2026,... Read more
DUBLIN / Dec 30, 2025 / Business Wire / Alkermes plc (Nasdaq: ALKS) announced today that its Chief Executive Officer, Richard Pops, will provide a corporate overview and update at the 44th Annual J.P. Morgan Healthcare Conference. The presentation will take place on Tuesday, Jan. 13, 2026 at 10:30 a.m. PST (1:30 p.m. EST/6:30 p.m. GMT). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.
About Alkermes plc
Alkermes... Read more
TORONTO / Dec 30, 2025 / Business Wire / Cybin Inc. (NYSE American:CYBN) (Cboe Canada CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to advancing mental healthcare by developing new and innovative next-generation treatment options, today announced that it has launched an at-the-market equity program (the “ATM Program”) to allow Cybin to issue and sell up to US$100,000,000 of common shares in the capital of... Read more
KELOWNA, BC / ACCESS Newswire / December 30, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, provides the following additional secondary and exploratory endpoint final results update on its Phase 1b, 12-week chronic study GLP-1-H24-4 (the "Study" or the "Lexaria Study"), recently completed in Australia, focusing on 4 DehydraTECH™ ("DHT") study arms relative to the Rybelsus® control... Read more
PALI-2108 is the first and only PDE4 inhibitor in development targetingthe terminal ileum and colon for treatment of ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD) to address significant unmet medical needs
Ongoing development of PALI-2108 across FSCD and UC, with Phase 2 IND submission planned for H1 2026 Carlsbad, CA, Dec. 30, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage b... Read more
Planned SAD and MAD Studies Mark Key Clinical Inflection Point for Intranasal PTSD and Anxiety SARASOTA, FL, Dec. 30, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a diversified developmental stage biopharmaceutical and cryptocurrency treasury company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced it has entered into a non-binding... Read more
Tividenofusp alfa treatment showed reduction and normalization in key disease biomarkers, stabilization or improvement in clinical endpoints including adaptive behavior, cognition and hearing, and normalization of liver volume
Most common treatment-related adverse events were infusion-related reactions, which decreased with continued use
Tividenofusp alfa is an investigational, next-generation enzyme replacement therapy engineered to cross the blood-brain bar... Read more
WALTHAM, Mass. and BOULDER, Colo., Dec. 30, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM). The submission is based on positive clinical data from the SUMMIT... Read more
Takeda regains a majority of XOMA Royalty’s royalty interest in mezagitamab (TAK-079)
XOMA Royalty will be entitled to payments based on a share of milestones and royalties associated with nine development-stage assets held within Takeda’s externalized assets portfolio EMERYVILLE, Calif., Dec. 30, 2025 (GLOBE NEWSWIRE) -- XOMA Royalty Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has amended its collaboration, originally... Read more
While the Phase 3 trial of vilobelimab in ulcerative pyoderma gangrenosum (PG) was terminated earlier this year due to futility regarding its prespecified primary endpoint (as previously disclosed), subsequent post-hoc analyses suggest a positive trend in favor of vilobelimab, with signals indicating a potentially consistent treatment effect
InflaRx anticipates meeting with the FDA to determine a potential development path forward in PG, which the Company anticipates... Read more
Royalty Pharma will now own 100% of the 8% to 16% Evrysdi royalty following multiple transactions with PTC since 2020 NEW YORK, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today announced that it has acquired the final portion of PTC Therapeutics’ remaining royalty on Roche’s Evrysdi for $240 million upfront and up to $60 million in sales-based milestones.
Evrysdi, marketed by Roche, is an orally administered survival motor neuron-2 (SMN2)... Read more
BOSTON / Dec 29, 2025 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that following evaluation of interim data from the RAMP 203 clinical trial in advanced KRAS G12C-mutated non-small cell lung cancer (NSCLC) it will discontinue the trial to focus resources on clinical development of VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, in advanced... Read more
Contract Research Organization for the REGAL trial has informed the Company that 72 events have occurred in the trial as of December 26, 2025; SELLAS remains blinded to trial outcomes
Timing of the final analysis is event-driven, and SELLAS will announce the occurrence of the 80th event NEW YORK, Dec. 29, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused... Read more
Neither study achieved its primary endpoint of reduction in annualized clinical fracture rate compared to placebo (ORBIT) or bisphosphonates (COSMIC)
Both studies achieved secondary endpoint of improvements in bone mineral density with strong statistical significance LONDON, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical stage biopharmaceutical company focused on rare diseases, today announced... Read more
Neither study achieved its primary endpoint of reduction in annualized clinical fracture rate compared to placebo (Orbit) or bisphosphonates (Cosmic)
Both studies achieved the secondary endpoint of improvements in bone mineral density with strong statistical significance
The Company will implement significant expense reductions NOVATO, Calif., Dec. 29, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced results from the Phase 3... Read more
PLYMOUTH MEETING, Pa., Dec. 29, 2025 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) for INO-3107 for review as a potential treatment for adults with RRP. The review classification designated... Read more
Further validates continuation of the B-FREE Study to evaluate the efficacy and safety of ARAKODA® (tafenoquine) for treatment of chronic babesiosis
Data support theory among specialists that Babesia infection may prolong recovery times in patients with chronic fatigue WASHINGTON, Dec. 29, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma” or the “Company”), a pharmaceutical company focused on developing... Read more
U.S. Patent expands the scope of patent protection and increases the number of molecules that Enveric has the potential to develop or license for the treatment of neuropsychiatric conditions. CAMBRIDGE, Mass. / Dec 29, 2025 / Business Wire / Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing novel neuroplastogenic small-molecule therapeutics to address psychiatric and neurological disorders, today announced the... Read more
EMA provided overall agreement with the proposed Phase 3 clinical trial of VCN-01 in combination with gemcitabine/nab-paclitaxel for the first-line treatment of metastatic PDAC, including sample size, repeated dosing of VCN-01, and an adaptive design to potentially optimize trial timelines and outcomes
Theriva to schedule an End-of-Phase 2 meeting with the FDA in H1 2026 to finalize the design of a pivotal multinational Phase 3 clinical trial
Theriva’s... Read more
CUPERTINO, Calif., Dec. 29, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will present at the Sachs 9th Annual Neuroscience Innovation Forum,... Read more
The Breakthrough Therapy Designation was granted based on the positive topline results from the Essential3 Phase 3 program in essential tremor
Praxis remains on track to submit ulixacaltamide NDA in early 2026 based on recently completed pre-NDA meeting with the FDA BOSTON, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies... Read more
Tiziana reports excellent safety profile with intranasal foralumab after 37.4 patient-years cumulative exposure
FDA denial of Sanofi’s tolebrutinib for nrSPMS shows need for safe therapy BOSTON, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana”), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces the submission of its seventh annual Development... Read more
neffy is the first epinephrine product approved for use out of a hospital setting in China for adults and children (>30 kg) living with severe allergic reactions
Pediatrix Therapeutics, which has a license from ARS Pharma to market neffy in China under the trade name 优敏速®, expects availability in the spring of 2026 SAN DIEGO, Dec. 29, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a commercial-stage biopharmaceutical company... Read more
Exploring clinical development plan options including a controlled human infection model (CHIM) and a Phase 2/3 adaptive field study
Expect to have investigational product of TNX-4800 (anti-Borrelia OspA mAb) available for clinical trials in early 2027
Approximately 70 million people that live, work or vacation in areas of the U.S. in which Lyme disease is endemic could potentially benefit from pre-exposure prophylaxis CHATHAM, N.J., Dec. 29, 2025 (GLOBE NEWSWIRE)... Read more
CELEBRATION, Fla., Dec. 29, 2025 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare disease, today announced that the Company has executed an exclusive expanded access distribution agreement with Uniphar, an Ireland-based pharmaceutical services provider with a proven record of success in global warehousing, distribution and supply chain management.... Read more
New PDUFA date expected in 1H 2026 within 30 days of NDA resubmission LOS ALTOS, Calif., Dec. 29, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it has resubmitted its 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for oxylanthanum carbonate (OLC), the Company’s... Read more
SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced that it has entered into an exclusive licensing agreement with ASK Pharm for its proprietary pan-RAS (ON) inhibitor AN9025.
Under the terms of the agreement, ASK Pharm will obtain exclusive rights... Read more
$4.1 million upfront with up to approximately $8.3 million of potential additional gross proceeds upon the exercise in full of warrants SAN DIEGO, CA / ACCESS Newswire / December 29, 2025 / Dermata Therapeutics, Inc. (Nasdaq:DRMA) (Nasdaq:DRMAW) ("Dermata," or the "Company"), a science-driven leader in dermatologic solutions, today announced the closing of its previously announced private placement for the issuance and sale of an aggregate of 2,022,062 shares of common... Read more
NEW YORK, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announces it has entered into a $6 million securities purchase agreement with investor, David E. Lazar, for the purchase of non-voting convertible preferred stock of the Company. Mr. Lazar has been appointed Indaptus’ Co-Chief... Read more
Filed for Breakthrough Designation for Multikine in Saudi Arabia
A 212-patient Confirmatory Registration Study for Multikine in PD-L1 low newly diagnosed head and neck cancer patients is currently in final stage of preparations - enrollment expected to begin Spring 2026
Plans to seek early approval in U.S. based on pre-surgical response rate upon full enrollment VIENNA, Va. / Dec 29, 2025 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) reported financial... Read more
While Celularity’s Biovance® and Biovance 3L products remained eligible for Medicare coverage under the now-withdrawn LCDs, Celularity CEO Dr. Robert J. Hariri welcomed the recent action taken under the leadership of CMS Administrator Dr. Mehmet Oz FLORHAM PARK, N.J., Dec. 26, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company addressing age-related and degenerative diseases, today released comments... Read more
RAMAT GAN, Israel, Dec. 26, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small-molecule drugs targeting oncological and inflammatory diseases, today announced that the Brazilian Patent Office (INPI) has granted Patent No. BR112015002697-4, entitled “Use of an A3 Adenosine Receptor Agonist for the Treatment of Sexual Dysfunction.”
The granted patent provides intellec... Read more
NEW HAVEN, Conn., Dec. 24, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today reported results from a Phase 2 proof-of-concept study evaluating BHV-7000 for the treatment of major depressive disorder (MDD). The study did not meet its primary endpoint, a reduction... Read more
Omeros to Host Conference Call Monday, December 29, 2025 at 4:30 p.m. ET
First and only approved option: YARTEMLEA® is the only approved treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) and is indicated for adults and children ages two years and older.
High complete response (CR) rates: YARTEMLEA-treated patients achieved CR rates of 61% in the pivotal trial and 68% in the Expanded Access Program (EAP) among those... Read more
In the CIRRUS-HCM trial, including interim safety results from Part D, EDG-7500 was generally well tolerated; no clinically meaningful reductions in LVEF or LVEF <50%
On track to deliver full 12-week Part D readout in 2Q 2026 and Phase 3 start in 4Q 2026 BOULDER, Colo., Dec. 24, 2025 /PRNewswire/ -- Edgewise Therapeutics, Inc., (Nasdaq: EWTX), today announced positive updates from the ongoing CIRRUS-HCM, Phase 2 clinical trial of EDG-7500, a novel... Read more
CAMBRIDGE, Mass. & MONTREAL / Dec 24, 2025 / Business Wire / Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a clinical-stage precision oncology company, today announced a definitive asset purchase agreement for Gilead Sciences, Inc. to acquire Repare’s polymerase theta (Polθ) ATPase inhibitor, RP-3467 (the “Gilead Agreement”).
“We are pleased to announce this transaction which combines Gilead’s leading expertise in oncology research... Read more
$4.1 million upfront with up to approximately $8.3 million of potential additional gross proceeds upon the exercise in full of warrants SAN DIEGO, CA / ACCESS Newswire / December 24, 2025 / Dermata Therapeutics, Inc. (NASDAQ:DRMA) (NASDAQ:DRMAW) ("Dermata," or the "Company"), a science-driven leader in dermatologic solutions, today announced that it has entered into definitive agreements for the issuance and sale of an aggregate of 2,022,062 shares of common stock... Read more
Dynavax stockholders to receive $15.50 in cash, a 39% premium to Dynavax closing share price on December 23, 2025 EMERYVILLE, Calif., Dec. 24, 2025 /PRNewswire/ -- Sanofi announced today that it has entered into an agreement to acquire Dynavax Technologies Corporation (Nasdaq: DVAX), a publicly traded vaccines company with a marketed adult hepatitis B vaccine (HEPLISAV-B®) and a differentiated shingles vaccine candidate. The acquisition augments Sanofi's presence... Read more
TORONTO, Dec. 24, 2025 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC: MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to have publicly filed its financial results for the periods ended August 31, 2025 and November 30th, respectively. All figures are reported in Canadian dollars. The Company’s... Read more
