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...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...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...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,...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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,...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...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...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...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...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...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...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...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...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 /...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,...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 /...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...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...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...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,...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,...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...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...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...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...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...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...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...Read more
TOKYO / Dec 22, 2025 / Business Wire / Incyte Biosciences Japan G.K. today announced approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for Minjuvi® (tafasitamab) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL). “Today's approval of Minjuvi in combination with rituximab and lenalidomide marks a significant milestone as the first dual-targeted CD19...Read more
TOKYO / Dec 22, 2025 / Business Wire / Incyte Biosciences Japan G.K. today announced the Japan Ministry of Health, Labour and Welfare (MHLW) approval of Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of advanced squamous cell carcinoma of the anal canal (SCAC). "Today's approval marks a significant milestone for patients with advanced anal cancer in Japan –...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,...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...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...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...Read more
Introduction of AVT05 supported by NHS England tender award in the United Kingdom REYKJAVIK, Iceland, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that launches are underway in Europe for Gobivaz® (golimumab), Alvotech’s biosimilar to Simponi® (golimumab), also known as AVT05...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...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...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...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...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...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...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),...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....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....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...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"...Read more
FOSTER CITY, Calif., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced financial results for the first half of 2025 ended June 30, 2025. First Half 2025 Financial Results Ended June 20, 2025 Cash, cash equivalents,...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,...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...Read more
BOSTON, Dec. 22, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA for the treatment of high risk and advanced cancer, announced the appointment of Jack E. Stover to its Board of Directors. Mr, Stover will join the Audit and the Nominating Committees as Dr. Magda Marquet steps down from the Audit Committee. Mr. Stover brings more than three decades of...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...Read more
BioMarin to Gain Galafold® (migalastat) for Fabry Disease and Pombiliti® (cipaglucosidase alfa-atga) + Opfolda® (miglustat) for Pompe Disease, Adding Two Marketed, High-Growth Products with $599 Million in Revenue Over Past Four Quarters Provides Opportunity to Expand Access to Galafold and Pombiliti + Opfolda to Patients in New Markets Across BioMarin's Global Footprint; Pending U.S. Galafold Patent Litigation Resolved Will...Read more
IRVING, Texas, Dec. 19, 2025 /PRNewswire/ -- Caris Life Sciences® (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, today announced that Providence Swedish Cancer Institute and the institute's focused translational research extension, the Paul G. Allen Research Center, have joined the Caris Precision Oncology Alliance™ (Caris POA). The Providence Swedish Cancer Institute,...Read more
MYQORZO, a Cardiac Myosin Inhibitor, Directly Addresses Underlying Hypercontractility Associated with Obstructive HCM FDA Approval Based on Results of SEQUOIA-HCM MYQORZO is Company’s First FDA-Approved Medicine Company to Host Investor Conference Call Today at 4:30 PM Eastern Time SOUTH SAN FRANCISCO, Calif., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug...Read more
FOSTER CITY, Calif. / Dec 19, 2025 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today announced that it has entered into a subscription agreement with entities associated with TCGX, an institutional investor, for a private placement of 1,000,000 shares of its common stock (the “Common Stock”). The Common Stock issued to the private placement investors at closing will be priced at $68.48 per...Read more
Improvements observed in key non-invasive markers of fibrosis across treatment arms versus placebo, with continued reductions from 24-week timepoint Additional weight loss from 24 to 48 weeks with 1.8 mg dose, without plateauing Favorable tolerability profile of pemvidutide preserved at 48 weeks, reinforced by low treatment-related discontinuation rate End-of-Phase 2 meeting with FDA supports advancing to registrational Phase 3...Read more
NORCROSS, Ga., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of galectin-3-targeted therapeutics for patients with MASH cirrhosis and portal hypertension, today announced that the U.S. Food and Drug Administration (FDA) has provided a written response, and subsequent communications, to the Company’s previously submitted Type C meeting request regarding the development program for...Read more
CAMBRIDGE, Mass., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that its development partner, GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an...Read more
ISELIN, N.J., Dec. 19, 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 financial results for fiscal year 2025. Financial Highlights for the Fiscal Year Ended September 30, 2025 For the fiscal year ended September 30, 2025, Outlook Therapeutics reported net loss attributable to...Read more
Reducing inflammation helps create a regenerative environment in the Central Nervous System TORONTO and HAIFA, Israel, Dec. 19, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) today announced new laboratory data demonstrating that its proprietary exosomes can significantly reduce inflammatory activity compared to untreated cells and cells treated with a commercially...Read more
New Patent Expands IGC Pharma's Pharmaceutical Cannabinoid Portfolio Beyond Alzheimer's Disease POTOMAC, MD / ACCESS Newswire / December 19, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company leveraging Artificial Intelligence (AI) to develop innovative treatments for Alzheimer's disease, today announced that the United States Patent and Trademark Office (USPTO) has officially...Read more
The PL-16 Viral Blocker has shown over 90% success in protection of cells against viruses Raanana, Israel, Dec. 19, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd., a pre-clinical-stage biotechnology company developing intranasal protective solutions, announced today that it has submitted a Pre-Request for Designation (Pre-RFD) to the U.S. Food and Drug Administration (FDA) for its PL-16 Viral Blocker, a non-pharmacological intranasal...Read more
With approximately $9.5 million in cash reserves and no debt, the Company is ready to leverage strengthened vertical integration as clinical-grade psilocybin moves into Phase IIb trials NEW YORK, Dec. 19, 2025 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, today announced...Read more
BioNTech has completed its exchange offer to acquire CureVac Acquisition complements BioNTech’s capabilities and proprietary technologies in mRNA design, delivery formulations, and mRNA manufacturing In total, approximately 86.75% of CureVac shares were tendered; BioNTech expects to complete the compulsory acquisition of the remaining CureVac shares in January 2026 as part of the previously announced post-offer reorganization CureVac...Read more
WILMINGTON, Del. / Dec 18, 2025 / Business Wire / Incyte (Nasdaq:INCY) announced today that it will present at the 44th Annual J. P. Morgan Healthcare Conference on Monday, January 12, 2026 at 8:15 am (PST). The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to...Read more
REDWOOD CITY, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced the first patient has been randomized in the RASolute 304 trial. RASolute 304 is a global, open-label, Phase 3 clinical trial evaluating the safety and efficacy of daraxonrasib, a RAS(ON) multi-selective inhibitor, in patients with...Read more
Up to $54.3 million CEPI investment aims to help advance Moderna's H5 pandemic influenza vaccine candidate to licensure Partnership strengthens global preparedness against a significant pandemic threat If licensed and in the event of an influenza pandemic, Moderna will allocate 20% of its H5 pandemic vaccine manufacturing capacity for timely supply to low- and middle-income countries at affordable pricing OSLO, NORWAY and...Read more
| Company | Change | Last Trade |
|---|---|---|
| Praxis Precision Medicines | 36.28 13.49 | $305.23 |
| Belite Bio | 14.03 9.06 | $168.96 |
| Bolt Biotherapeutics | 4.65 830.36 | $5.22 |
| Greenwich LifeSciences | 3.70 17.88 | $24.40 |
| Ascendis Pharma | 2.39 1.14 | $211.49 |
| Rhythm Pharmaceuticals | 2.27 2.06 | $112.40 |
| AnaptysBio | 1.79 3.57 | $51.89 |
| Lyell Immunopharma | 1.22 3.48 | $36.31 |
| Lipocine | 1.04 19.85 | $6.27 |
| Mirum Pharmaceuticals | 0.75 0.95 | $80.01 |
| BioNTech | 0.67 0.71 | $95.19 |
| Omeros | 0.61 3.88 | $16.32 |
| Nutriband | 0.58 12.08 | $5.38 |
| Jazz Pharmaceuticals | 0.56 0.33 | $171.04 |
| Prelude Therapeutics | 0.52 21.22 | $2.97 |
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...
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