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
PORTLAND, Maine, Dec. 24, 2025 (GLOBE NEWSWIRE) -- ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell”), an animal health company that develops, manufactures and markets products that improve cattle health and productivity today announced that it received an Incomplete Letter from the United States Food and Drug Administration (FDA) on December 23, 2025 for its Re-Tain® New Animal Drug Application (NADA), and simultaneously that it is increasing its First Defense®... Read more
AQVESME is the only FDA-approved medicine for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
Marketed under AQVESME brand name in the U.S. for thalassemia indication; PYRUKYND® (mitapivat) remains the U.S. brand name for PK deficiency indication
AQVESME expected to be available in late January 2026, following AQVESME REMS program implementation
Company will host investor conference call and webcast tomorrow, December... Read more
SAN DIEGO / Dec 23, 2025 / Business Wire / Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies based on its proprietary Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, today provided a program update on its ongoing Phase 1 study evaluating JANX008, its EGFR-targeted TRACTr, in multiple solid... Read more
DehydraTECH-semaglutide reduced overall side effects by 48% as compared to Rybelsus® DehydraTECH-semaglutide reduced gastrointestinal side effects by 55% as compared to Rybelsus® Recent financings create runway for prospective new 2026 development opportunities KELOWNA, BC / ACCESS Newswire / December 23, 2025 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, provides... Read more
Calgary, Alberta--(Newsfile Corp. - December 23, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company"), an autologous stem cell company treating those who suffer in pain from peripheral arterial disease, chronic limb threatening ischemia, angina, ischemic cardiomyopathy, dilated cardiomyopathy, total body ischemia, vascular dementia, is pleased to announce the appointment of Dr. David B. Alper, DPM, FFPM RCPS, to a lead role as... Read more
Nonclinical protocol study design accepted by FDA
Study to commence in First Quarter 2026 King of Prussia, Pennsylvania--(Newsfile Corp. - December 23, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL® gene silencing technology to eliminate cancer. Phio announced today that it has taken a major step forward in its drug development program for PH-762. The company... Read more
Akari Will Exclusively Partner With Industry Leader WuXi XDC For This Key IND-enabling Work TAMPA, Fla. and LONDON, Dec. 23, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel payloads, today announced the initiation of GMP manufacturing activities to support the development of AKTX-101, the Company’s lead ADC program.
Akari has selected WuXi XDC, the world’s... Read more
Deep and durable responses observed in a heavily pretreated, historically immunotherapy-resistant population
Findings reinforce the broad, pan-tumor activity of BOT+BAL across immunologically “cold” cancers LEXINGTON, Mass. / Dec 23, 2025 / Business Wire / Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced the publication of clinical results from the ovarian cancer cohort of its Phase 1b C-800-01 trial evaluating botensilimab plus... Read more
The CTA No Objection Letter from Health Canada allows for initiation of patient enrollment in the ALSTARS Trial at Canadian ALS centers.
The ALSTARS Trial is a phase 2, placebo-controlled study that includes clinical sites in the United States and Canada to evaluate the efficacy and safety of COYA 302 for the treatment of ALS
The ALSTARS Trial is underway in the United States and will now proceed in Canada HOUSTON / Dec 23, 2025 / Business Wire / Coya Therapeutics,... Read more
NEW YORK, Dec. 23, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, today announced that it will host a conference call and live webcast at 4:00 p.m. ET on Wednesday, January 7, 2026 to provide an update on 12-month overall survival (OS) from its ongoing Phase 2a clinical trial of atebimetinib + modified Gemcitabine / nab-paclitaxel (mGnP) in first-line... Read more
Studies Will Support Investigational New Drug Application (IND) with the US FDA, Including Design of Phase 2 Trial TORONTO, Dec. 23, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (Upstream: QNTM) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and... Read more
Written feedback from FDA pre-NDA meeting includes a recommendation to conduct a second Phase 3 trial to generate additional efficacy and safety data prior to NDA submission of brilaroxazine for the treatment of schizophrenia
Current data package highlights long-term safety profile, broad-spectrum clinical activity, and favorable adherence observed to date for once daily brilaroxazine over up to one year
Initiation of RECOVER-2 registrational trial planned in H1 2026,... Read more
COBENFY is the first major advance in schizophrenia treatment in decades, offering a novel mechanism of action distinct from other therapies
COBENFY has already been included in China’s national-level schizophrenia treatment guidelines, underscoring the urgent need for new therapeutic options in China SHANGHAI & CAMBRIDGE, Mass. / Dec 23, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products... Read more
NEW HAVEN, Conn., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VYD2311, an investigational vaccine-alternative monoclonal antibody candidate for the prevention of COVID.
Fast Track is a process that enables the FDA to expedite the development and review of new drugs that address a serious or life-threatening condition and fill an unmet medical need.... Read more
DECLARATION is a Phase 3, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of VYD2311 in the prevention of COVID versus placebo, at three months, from a single intramuscular (IM) dose, with protection beyond three months anticipated
A second arm will evaluate monthly IM doses versus placebo to demonstrate the safety and efficacy of more frequent dosing to support individual choice should at-risk persons seek periodic extra... Read more
MINNEAPOLIS, Dec. 23, 2025 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that Kim Kelderman, President and Chief Executive Officer, will present at the 2026 J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 9:00 a.m. PST. A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne's Investor Relations website at https://investors.bio-techne.com/ir-calendar.
About Bio-Techne
Bio-Techne Corporation (NASDAQ:... Read more
LBL-047 (DNTH212) is a bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function
Top-line results in healthy volunteers anticipated in 2H’26
Dianthus to provide update on indication prioritization in 1H’26
LBL-047 (DNTH212) has the potential to be a first-line biologic in multiple autoimmune disorders with patient-friendly S.C.... Read more
VANCOUVER, British Columbia, Dec. 23, 2025 (GLOBE NEWSWIRE) -- Algernon Health Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a Canadian healthcare company, announces an increase to its non-brokered private placement financing, previously announced on November 6, 2025, to $750,000 and the closing of the third tranche (the “Third Tranche”). Gross proceeds from the Third Tranche totaled CAD $352,500 from the sale of 5,035,714 units... Read more
BOSTON, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Vor Biopharma Inc. (Nasdaq: VOR), a clinical-stage biotechnology company dedicated to transforming the treatment of autoimmune diseases, today announced the appointment of Andrew Levin, M.D., Ph.D., Partner at RA Capital Management, and Wouter Joustra, General Partner at Forbion, to its Board of Directors. Their appointments follow the Company’s recently announced $150M PIPE financing, which included participation from... Read more
WALTHAM, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced the appointment of Vikram Karnani to its Board of Directors. Mr. Karnani brings extensive commercial and executive leadership experience in rare disease and biopharmaceuticals, serving as the current chief executive officer of Collegium... Read more
Approval based on global Phase 3 program in children demonstrating Dupixent significantly reduced exacerbations (by 54% to 65%) and improved lung function (by 4.68% to 5.32%) compared to placebo
Dupixent is the first and only biologic medicine to demonstrate improved lung function in this young patient group in a randomized Phase 3 trial, and inhibits IL-4 and IL-13, two key and central drivers of type 2 inflammation TARRYTOWN, N.Y. and PARIS, Dec. 23, 2025 (GLOBE... Read more
Cancer Immunotherapy, LYMPHIR™, launched in the U.S. in December 2025
Completed $36 million in strategic financings, of which $18 million was via private placement and concurrent registered direct offering on December 10, 2025, to strengthen cash position and support continued commercialization of LYMPHIR CRANFORD, N.J., Dec. 23, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals,... Read more
Subsidiary, Citius Oncology, launches cancer immunotherapy, LYMPHIR™, in the U.S. in December 2025 CRANFORD, N.J., Dec. 23, 2025 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal year ended September 30, 2025.
"2025 was a pivotal year for... Read more
SAN DIEGO, Dec. 22, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that its Phase 3 KINECT®-DCP study evaluating the efficacy, safety, and tolerability of valbenazine in pediatric and adult participants who have dyskinetic cerebral palsy (DCP) did not meet primary or key secondary endpoints. The primary objective of the study was to assess improvement in chorea, a type of involuntary movement, in individuals with DCP.
"These... Read more
TARRYTOWN, N.Y., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast its presentation at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026. The presentation is scheduled for 2:15 p.m. Pacific Time (5:15 p.m. Eastern Time) and may be accessed from the "Investors & Media" page of Regeneron's website at http://investor.regeneron.com/events-and-presentations. A replay and transcript of the webcast... Read more
BOSTON / Dec 22, 2025 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Dr. Reshma Kewalramani, Chief Executive Officer and President, will present at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026, at 5:15 p.m. ET/2:15 p.m. PT.
A live webcast of management’s remarks will be available through the Vertex website, www.vrtx.com, in the "Investors" section under the "News and Events" page. A replay of the... Read more
BOSTON, Dec. 22, 2025 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA) today announced its partnership with Carnegie-Mellon University (CMU) for an award by the Advanced Research Projects Agency for Health (ARPA-H) for its POSEIDON program (Platform Optimizing SynBio for Early Intervention and Detection in Oncology). With Ginkgo Bioworks serving as the Commercial Partner, the project will also be led by Rebecca Taylor (principal investigator), professor of mechanical engineering... Read more
Vancouver, British Columbia--(Newsfile Corp. - December 22, 2025) - Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU) ("Entheon" or the "Company") is pleased to announce that it has entered into a binding Letter of Intent (the "LOI") dated December 18, 2025, with Nutravisor Inc. ("Nutravisor") whereby Entheon will acquire all of the issued and outstanding common shares of Nutravisor (the "Proposed Transaction"). Upon completion of the Proposed Transaction,... Read more
Clinical and Biomarker Outcomes Expected to Be Reported in Q1 2026 CAMBRIDGE, Mass., Dec. 22, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today reported completion of the safety analysis from its proof-of-concept Phase 2, randomized, double-blind, placebo-controlled NST-AD-001 study of PrimeC combination in Alzheimer's... Read more
This acquisition establishes Niagen Bioscience as the sole owner of the most comprehensive and defensible intellectual property portfolio in the NAD+ industry LOS ANGELES / Dec 22, 2025 / Business Wire / Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today announced that it has acquired a comprehensive portfolio of existing patents covering nicotinamide riboside (NR)... Read more
Novel PTH analog achieves sustained calcium elevation for >3 days from single oral tablet, supporting development path toward once-daily alternative to daily injections JERUSALEM, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides and proteins replacement therapies, today announced new validating in vivo pharmacokinetic and pharmacodynamic data that supports further... Read more
Four autoimmune patients treated to date demonstrate deep B-cell depletion sustained for at least 28 days; initial efficacy data suggest significant clinical improvement in patients dosed at the 100 million cell dose, with the first systemic lupus erythematosus (SLE) patient achieving Definitions of Remission in SLE (DORIS) remission through Month 6
An additional Phase 1 basket trial has been initiated for zugo-cel in refractory primary immune thrombocytopenic purpura... Read more
The BLA was Resubmitted with FUJIFILM Biotechnologies (Fujifilm) as the Drug Substance Manufacturer and Priority Review was Requested LANGHORNE, Pa. / Dec 22, 2025 / Business Wire / Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced today that it has resubmitted the MOLBREEVI BLA to the FDA, with Fujifilm as the drug substance manufacturer. The MOLBREEVI BLA submission is seeking... Read more
Firmonertinib has the potential to redefine first-line treatment in this underserved population as a once daily, oral, brain-penetrant, chemo-free monotherapy
ALPACCA pivotal trial is designed to support potential accelerated and full regulatory approvals NEWTOWN SQUARE, Pa., Dec. 22, 2025 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative bioph... Read more
Results published in Journal of Vascular Surgery Cases, Innovations and Techniques (JVS-CIT)
After up to 36 months of follow-up, patients demonstrated high limb salvage, low rates of infection, no unprovoked structural failures
Results represent first prospective long-term data in traumatic arterial repair using an off-the-shelf biologic conduit DURHAM, N.C., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage bi... Read more
Single-ascending dose portion of study has successfully completed 2.5 and 7 mg / kg levels
Dose dependent immunosuppressive effect against a strong foreign antigen observed with continued favourable safety profile
Substantial reduction in T cell activity highlights the potential efficacy of IMP761 in treating autoimmune diseases
Given encouraging efficacy and safety, the trial will continue as planned and further updates are anticipated in 1H CY2026 including presentation... Read more
The engagement establishes a multi-phase framework to support AI enabled capital efficient development of Teverelix, a next generation GnRH antagonist, as a first in class market product for acute urinary retention (AURr) and high CV risk prostate cancer collectively representing ~$6 billion in potential market opportunity PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / December 22, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a precision guided... Read more
NEW YORK, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, today announced that R. Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics, will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 7:30 AM PT in San Francisco, California.
The event will be webcast live under the News... Read more
PDUFA target action date of June 30, 2026
Priority Review designation is granted to applications for drugs that, if approved, would be a significant improvement in the safety or effectiveness of treating a serious condition
Veligrotug now has both Priority Review and Breakthrough Therapy Designations, each following requests which included data on veligrotug’s (i) consistent and robust improvement and resolution of diplopia in chronic TED, and (ii) rapid... Read more
Enrollment Completed in C-BEYOND Phase 3 Trial with More Than 880 HCV Treatment-Naïve Patients in US and Canada
C-BEYOND Topline Results Expected Mid-2026
C-FORWARD Phase 3 Trial, Conducted Outside North America, Enrollment Completion Expected Mid-2026 with Topline Results Anticipated Year-End 2026
C-BEYOND AND C-FORWARD are the First Global Phase 3 Head-to-Head Trials of Direct-Acting Antivirals for Treatment of HCV BOSTON, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Atea... Read more
HAIFA, Israel, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Pluri, Inc. (“Pluri”, the “Company”, “we” or “us”) (Nasdaq, TASE: PLUR), a leading biotechnology company leveraging its proprietary platform for cell-based solutions through a collaborative network of ventures, today announced expansion of its manufacturing agreement signed in 2024 with Remedy Cell Ltd. (“Remedy Cell”), an innovative biopharmaceutical company developing stem cell-derived, cell-free therapeutics... Read more
CAMBRIDGE, Mass., Dec. 22, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that James Porter, Ph.D., Chief Executive Officer, will present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 9:00 a.m. PT in San Francisco
A live webcast will be... Read more
FRAMINGHAM, Mass. & SALISBURY, England / Dec 22, 2025 / Business Wire / KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing approval for EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. EKTERLY is the first and only oral on-demand... Read more
