CAMBRIDGE, Mass. / Dec 13, 2025 / Business Wire / Scholar Rock (NASDAQ: SRRK; the “Company”), today announced that the company granted inducement equity awards covering an aggregate of 7,800 shares of its common stock to two newly hired employees, consisting of inducement stock options to purchase an aggregate of 4,457 shares of common stock and inducement restricted stock units, covering an aggregate of 3,343 shares of its common...Read more
Final Decision from European Commission Expected in Q1 2026 SOUTH SAN FRANCISCO, Calif., Dec. 12, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization in the European Union (EU) for MYQORZO® (aficamten), a cardiac myosin inhibitor,...Read more
DAYBUE STIX provides Rett syndrome patients and caregivers with new flexibility and choice in their treatment with DAYBUE DAYBUE and DAYBUE STIX are the only FDA-approved treatments for Rett syndrome, a rare neurodevelopmental disorder SAN DIEGO / Dec 12, 2025 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has approved DAYBUE® STIX (trofinetide) for oral...Read more
Launch-HTN, the largest trial of an aldosterone synthase inhibitor conducted among participants with uncontrolled or treatment-resistant hypertension, was one of nine studies selected as most impactful of 2025 by JAMA editors RADNOR, Pa., Dec. 12, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related...Read more
The Phase 3 STAR-221 study evaluating a domvanalimab-based combination in upper gastrointestinal cancers will be discontinued due to futility Arcus is continuing to expand its development program for casdatifan, a potential best-in-class HIF-2a inhibitor with robust single-agent activity, and multiple data readouts are expected in 2026 Arcus’s early development efforts will focus on five programs targeting inflammatory and autoimmune...Read more
ANKTIVA plus BCG is the first immunotherapy for non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, to receive a positive recommendation for marketing authorization in Europe. For patients whose disease does not respond to BCG, there are currently no authorized treatment options; the primary option is surgical removal of the bladder. Unlike the U.S., where only one BCG substrain is...Read more
FDA approval was based on results from the largest Phase 3 clinical trial ever conducted for a new treatment against Neisseria gonorrhoeae infection in regions with a high prevalence of gonorrhea across five countries. NUZOLVENCE is one of the first new treatments approved by the FDA for uncomplicated urogenital gonorrhea in nearly two decades. Gonorrhea affects more than 82 million people worldwide each year and is the second...Read more
Efficacy data remain consistent with previous disclosures, showing 10.3-month median PFS in all patients and 11.4-month median PFS in 2L patients Subset analyses show broad activity in patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer, regardless of prior fulvestrant or other SERD exposure, or ESR1 mutation status Phase 3 ReDiscover-2 trial in CDK4/6-experienced breast cancer ongoing CAMBRIDGE, Mass., Dec. 12, 2025...Read more
NEW YORK, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today provides an update on the regulatory...Read more
First Patient Expected to be Dosed Next Week with Intranasal Foralumab PET Scan Shows Presence of Untreated Neuroinflammation in Alzheimer’s Patient on Leqembi® (Lecanemab) Anti-Amyloid Therapy BOSTON, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal...Read more
First FDA approved treatment in 30+ years for more than 2 million Americans with PSVT Novel nasal spray designed to rapidly resolve episodes of PSVT and restore sinus rhythm FDA approval in PSVT enables development of AFib-RVR under sNDA pathway Milestone well-capitalized to launch and commercialize CARDAMYST with existing capital and royalty financing Conference call and webcast December 15, 8:00 a.m. ET MONTREAL and...Read more
SOUTH SAN FRANCISCO, Calif., Dec. 12, 2025 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, today announced that Neil Berkley, who has served as Alector’s Chief Business Officer (CBO) since March 2024, and CBO and Interim Chief Financial Officer (CFO) since June 2025, has been appointed CFO, effective...Read more
Consistent OS benefit in an Asian subset with a strong HR of 0.69 for non-squamous patients, and meaningful safety advantage position Plinabulin as a late-stage candidate showing survival improvement in 2L/3L EGFR WT NSCLC. FLORHAM PARK, N.J., Dec. 12, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage biopharmaceutical company developing first-in-class immune-modulating cancer therapies, today announced...Read more
Supported by Scientific Evidence Showing Tissue Repair Quality of Company’s Exosomes TORONTO and HAIFA, Israel, Dec. 12, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a preclinical-biotechnology company developing exosome-based therapies for central nervous system injuries, today announced meaningful progress in its long-term clinical-readiness strategy. The...Read more
ATNM-400's target antigen is overexpressed in breast cancer and its expression is further increased in breast cancer cells resistant to standard of care endocrine therapy, tamoxifen and the HER2 therapy trastuzumab The Actinium-225 alpha-emitter payload of ATNM-400 induced irreversible double-strand DNA breaks and has the potential to produce potent localized tumor killing with reduced off-target lung toxicity that limits the use of...Read more
Company continues preclinical studies for Thykamine™ in MASH and Fibrosis, furthering the understanding of Thykamine™'s mechanism of action. Thykamine™: A New Player in the Field of Anti-Inflammatory Drugs published in the peer reviewed journal, Biomedicines. Design for Thykamine™ Phase 2/3 clinical study in pediatric Atopic Dermatitis is complete based on the positive results of the phase 2 in an adult population. Thykamine™...Read more
TORONTO, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the fiscal year ended September 30, 2025 and provided an update on its business. During the year, the company initiated manufacturing activities for a Phase 2 study of Edesa’s dermatology drug...Read more
Vancouver, Canada, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on the discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced the publication of a review article validating the therapeutic promise of its proprietary candidate, MEAI...Read more
CAMBRIDGE, Mass. / Dec 12, 2025 / Business Wire / Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today announced the closing of its previously announced exercise of certain outstanding warrants to purchase up to an aggregate of 426,390 shares originally issued in February 2025 and...Read more
LA JOLLA, CA, Dec. 12, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the closing of its previously announced public offering of an aggregate of 10,666,667 shares of its common stock (or common stock equivalents in lieu...Read more
Roivant enters new phase of corporate journey with 3+ launches, 4+ NDA/BLA filings, 8+ pivotal and 3+ proof-of-concept study readouts expected over the next three years Highlighting clinical execution, Roivant announces positive updates to timing guidance across four key programs: Brepocitinib NDA filing in dermatomyositis (DM) now expected in early calendar year 2026; commercial preparation underway with launch expected early in...Read more
Collaboration aims to automate RNA and protein detection in 3D tissue specimens, reducing complexity and technical barriers. Innovation has the potential to improve preclinical research by reducing reliance on animal testing through New Approach Methodologies (NAMs) such as organoids and predictive modeling, enabling new directions and scale in advanced biomedical studies. Partnership underscores Bio-Techne's commitment to drive...Read more
BMI and hyperphagia reductions have been observed in patients with PWS treated with setmelanotide at Month 3 (n=8) and Month 6 (n=5); 17 of 18 enrolled patients remain on therapy Promising results supportive of Phase 3, registrational trial of setmelanotide in PWS Company initiated Phase 1, Part D study to evaluate weekly MC4R agonist RM-718 in patients with PWS Company to hold conference call on Thursday, December...Read more
EMBOLD data to serve as basis of efficacy and safety following discussion with the FDA BOSTON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the successful completion of the...Read more
WATERTOWN, Mass., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, today announced the closing of its upsized underwritten public offering of $602.0 million of shares of its common stock. Kymera sold and issued 8,050,000 shares of its common stock, which includes 1,050,000 shares...Read more
Fast Track designation supported by positive results from the KT-621 BroADen Phase 1b atopic dermatitis (AD) patient trial KT-621 BROADEN2 Phase 2b AD trial ongoing, with data expected to be reported by mid-2027 and BREADTH Phase 2b trial in asthma on track to initiate in 1Q26 WATERTOWN, Mass., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing...Read more
For patients whose time to progression on immediate prior therapy was >18 months, median progression-free survival (“PFS”) was 12.4 months with gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and 10.0 months with gedatolisib + fulvestrant (“gedatolisib doublet”) versus 1.9 months for fulvestrant For patients enrolled in the U.S., Canada, Western Europe, and Asia Pacific, median PFS was 16.6 months with the...Read more
Phase 3 study builds on positive phase 2 results showing rapid and sustained reductions in key disease biomarkers and clinical measures of CAH SAN DIEGO, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the first patient has been dosed in the CALM-CAH Phase 3 trial evaluating investigational candidate atumelnant, a novel, once-daily, oral adrenocorticotropic hormone (ACTH) receptor...Read more
FOSTER CITY, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage oncology company, today announced the closing of its previously announced underwritten public offering of 18,687,500 shares of its common stock, including 2,437,500 shares sold pursuant to the underwriters’ exercise in full of their option to purchase additional shares, at a public offering price...Read more
Mario Alberto Accardi PhD, President and founder of Centessa’s Orexin Program, appointed Chief Executive Officer and member of the Board of Directors BOSTON and LONDON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company, today announced that its Board of Directors has appointed Mario Alberto Accardi PhD, President and founder of Centessa’s Orexin Program, as Chief...Read more
Targeted enrollment of 435 patients to enable potential full approval filing has been completed in OptimUM-02 trial Topline data, including median PFS, are expected in 1Q 2026 to support a potential accelerated approval filing in the United States SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, today announced it has completed its...Read more
WALTHAM, Mass., Dec. 11, 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 closing of its previously announced upsized underwritten public offering of 21,827,549 shares of its common stock at a public offering price of $18.44 per share, which includes 2,847,071 shares...Read more
NEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that an independent peer-reviewed comparative analysis of efficacy and safety between remestemcel-L and ruxolitinib for treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) was presented at the 67th ASH Annual meeting in Florida this past...Read more
NEW YORK and AMSTERDAM, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Atai Beckley N.V. (NASDAQ: ATAI) (“AtaiBeckley” or the “Company”), a clinical-stage biopharmaceutical company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments, today announced that the United States Patent and Trademark Office has granted a new patent covering EMP-01 (oral R-MDMA), further strengthening the...Read more
Phase 3 findings show oral zoliflodacin to be non-inferior to the combination of ceftriaxone and azithromycin for the treatment of uncomplicated urogenital gonorrhea. Positive study results are a significant milestone in the development of a first-in-class single-dose, oral antibiotic against gonorrhea, including infections caused by drug-resistant Neisseria gonorrhoeae, an urgent public health threat and high-priority...Read more
In a pretreated population of participants with advanced/metastatic cancer and the majority with prior PD-(L)1 treatment, BHV-1510 2.5 mg/kg Q3W plus cemiplimab resulted in confirmed objective response rates 3/5 (60%) in NSCLC, 4/4 (100%) in endometrial cancer, and 1/2 (50%) in urothelial cancer There were low rates of adverse events attributed to unconjugated payload such as hematological toxicities and diarrhea, and there...Read more
Once Granted, the Patent Will Provide Protection for MOLBREEVI in Europe Until March 2041 Savara Was Also Recently Granted a European Patent Covering the Investigational Drug-Device Combination of MOLBREEVI Delivered Via PARI’s Proprietary eFlow® Nebulizer System LANGHORNE, Pa. / Dec 11, 2025 / Business Wire / Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory...Read more
IMA203CD8 is a second-generation PRAME cell therapy with enhanced pharmacology in ongoing Phase 1a dose escalation Manageable tolerability across all dose levels Encouraging early clinical anti-tumor activity in advanced solid tumors after one-time infusion of IMA203CD8 at a low median dose during ongoing dose escalation, including deep and durable responses Promising dose-dependent clinical signal in ovarian carcinoma supports the...Read more
Rick Fair, a seasoned executive with deep experience developing and commercializing hematology products, joins Enliven as Chief Executive Officer Co-Founder Sam Kintz will assume a new position as Head of Pipeline BOULDER, Colo., Dec. 11, 2025 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule...Read more
FREMONT, Calif. / Dec 11, 2025 / Business Wire / Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced the publication of one of the largest and most comprehensive patient cohorts to date from the landmark TRACERx study, in the journal Cell. The study, titled "Longitudinal ultrasensitive ctDNA monitoring for high-resolution lung cancer risk prediction," demonstrates the clinical importance of...Read more
Inhibiting prolactin receptor (PRLR) signaling with the ABS-201 anti-PRLR antibody promotes human hair follicle growth ex vivo Human ex vivo data validate ABS-201’s potential to reverse follicular miniaturization and drive vellus-to-terminal hair regeneration by demonstrating that it prolongs anagen, stimulates keratin synthesis, and modulates the stem cell niche Full dataset will be presented during today’s ABS-201 Key Opinion...Read more
Results show, for the first time, that targeting underlying a-syn pathology with an active immunotherapy could slow the rate of progression of Parkinson’s disease Clear safety profile with no clinically relevant safety issues reported Targets met for immunogenicity (100% responder rate), pharmacodynamic effect, target engagement and clinical assessments Underlines potential and importance of active immunotherapies in precision...Read more
CLEVELAND, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced activation of The University of Texas Medical Branch (UTMB) in Galveston, Texas, as the newest Qualified Treatment Center (QTC) for the administration of ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets. ZEVASKYN, a first-of-its-kind, FDA-approved autologous, gene therapy is indicated for the treatment of wounds in adult...Read more
SAN DIEGO / Dec 11, 2025 / Business Wire / Contineum Therapeutics, Inc. (Nasdaq: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced the commencement of an underwritten public offering of $75.0 million of shares of its Class A common stock. In addition, Contineum intends to grant...Read more
CRB-913 was safe and well-tolerated across all doses studied Daily neuropsychiatric assessments using CSSRS, PHQ-9, and GAD-7 were negative for all participants A placebo-adjusted mean weight loss of 2.9% was observed at Day 14 in a dedicated cohort of people with obesity (n=12) A 12-week dose-finding study in people with obesity initiated with completion expected in summer 2026 Company to host conference call and live webcast today...Read more
Study did not meet the primary or key secondary endpoint 45% reduction in hypoglycemia events observed at top ersodetug dose (10 mg/kg) compared to 40% improvement in placebo arm Management to host conference call today at 8:30am ET REDWOOD CITY, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by...Read more
Antigen spreading was evaluated in a subset of Phase 2 patients to assess the ability of ELI-002 7P to broaden immune responses to personalized tumor neoantigens not present in the targeted immunotherapy 87% (13/15) of evaluated patients demonstrated induction of T cell responses to tumor neoantigens beyond mKRAS following ELI-002 7P therapy The induction of non-mKRAS antigen-specific T cell responses supports the potential for...Read more
MyPEAK-1 Protocol Amendments Agreed Upon with FDA; Tenaya Implementing Changes with Sites SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced it has received official notification from the U.S....Read more
TN-401 was Well Tolerated at 3E13 vg/kg dose Robust Transduction and Demonstrated Increases in PKP2 Protein Levels in First Two Patients at Week 8 Clinically Meaningful Reductions in Arrhythmia Burden Observed in First Two Patients with More Than Six Months of Follow-Up Tenaya Management to Host a Webcast Conference Call Thursday, December 11 at 5:00 pm ET to Review Preliminary Results SOUTH SAN FRANCISCO, Calif., Dec. 11,...Read more
SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (Nasdaq: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced that it intends to offer and sell units consisting of common stock and warrants to purchase shares of common stock. Tenaya may also sell to certain...Read more
Vaccine Was Safe and Well Tolerated at the Maximum Tolerated Dose Results Support Advancement of the Program into Phase 2 Development Combination of Keytruda® and the vaccine generated T cell responses and showed no major additional side effects, supporting plans for a Phase 2 neoadjuvant combination study in newly diagnosed breast cancer patients SAN JOSE, Calif., Dec. 11, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa"...Read more
Designation expands (Z)-Endoxifen program into rare pediatric neuromuscular disease and may qualify Atossa for a future Priority Review Voucher upon approval SEATTLE, Dec. 11, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, today announced that the U.S. Food and...Read more
CNSide Diagnostics now licensed in 48 U.S. States covering over 90% of the U.S. population HOUSTON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces that it has...Read more
In DUBLIN-3 non-squamous EGFR WT NSCLC patients who progressed after anti-PD-(L)1, Plinabulin + docetaxel showed consistent and clinically meaningful improvements in OS, PFS, and ORR, reinforcing Plinabulin as a late-stage therapy with consistent survival benefit in anti-PD-(L)1-progressed NSCLC patients. Supported by anti-cancer efficacy and safety in significant reduction exposure-adjusted grade 3/4 adverse events in DUBLIN-3,...Read more
JENA, Germany, Dec. 11, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that the World Health Organization (WHO) has granted the international nonproprietary (generic) name (INN) of “izicopan” to the Company for its orally available C5aR inhibitor, formerly known as INF904, in accordance with the WHO's Procedure...Read more
Oral presentation of ALG-055009 in vivo nonclinical data showcases synergistic fat mass loss in combination with incretin receptor agonists SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced positive data from four...Read more
Key milestone achieved as Company advances clinical program to full approval trial of ateganosine sequenced with a checkpoint inhibitor in comparison to chemotherapy CHICAGO, Dec. 11, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that the first patient has been dosed...Read more
MISSISSAUGA, Ontario / Dec 11, 2025 / Business Wire / Covalon Technologies Ltd. (the "Company" or "Covalon") (TSXV: COV; OTCQX: CVALF), an advanced medical technologies company, today announced its fiscal 2025 fourth quarter and full 2025 fiscal year results for the period ended September 30, 2025, along with a number of important recent achievements and highlights. Brent Ashton, Covalon’s Chief Executive Officer, commented, “Covalon has...Read more
The Accepted Abstract Provides Supportive Evidence for the TAMP™ Therapy Platform’s Novel, Localized Approach to Targeted Chemotherapeutic Delivery via Additional Pharmacokinetic and Pharmacodynamic Data MOUNTAIN VIEW, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or “the Company”) (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a...Read more
Poster PS5-08-16 Reports Early Observations from the INVINCIBLE-4 Study, an Ongoing Randomized, Presurgical Phase 2 Clinical Trial for Triple Negative Breast Cancer continue to show favorable safety 50% fewer grade 3 or higher Adverse Events were observed in the INT230-6 cohort compared to the Standard of Care ("SOC") neoadjuvant chemotherapy alone cohort. Poster PS4-10-15 Describes An Overview of a Potential Phase 3 Clinical...Read more
Novel first-in-class therapeutic targeting a key immune signaling pathway and the underlying cause of HIT It is the first and only potent, highly selective inhibitor of human 12-LOX in clinical testing, distinguishing it from related compounds. Orphan Drug and Fast Track designations from the FDA PONTE VEDRA, Fla., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company...Read more
Applied Therapeutic’s lead drug candidate, govorestat, is a novel central nervous system penetrant Aldose Reductase Inhibitor for the treatment of CNS rare metabolic diseases NEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT; “Applied”), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare diseases, today announced a definitive agreement for Cycle Group...Read more
Investment to Fund Phase 1 Study in Renal Allograft Antibody-Mediated Rejection (AMR) in China SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / December 11, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI, the "Company"), a clinical-stage biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, today announced that the Company has entered...Read more
Ra’anana, Israel, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today announced new results from its ongoing preclinical evaluation of its proprietary intranasal naloxone hydrogel formulation, demonstrating promising permeation kinetics that complement the Company’s previously reported stability and...Read more
BOSTON, Dec. 11, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ) and Quantum Leap Healthcare Collaborative ("Quantum Leap") today announce a new collaboration to evaluate TransCode's lead therapeutic candidate TTX-MC138 as part of the Quantum Leap PRE-I-SPY clinical trial platform. The PRE-I-SPY program will incorporate TTX-MC138 in a Phase 2a dose-expansion clinical trial enrolling up to 45 patients with...Read more
Data demonstrates the significant and sustained tumor regression achieved by the CAPTN-3 platform across two distinct tri-specific antibodies, IM1240 and IM1305, targeting different tumor antigens Transcriptomic analysis across ~11,000 TCGA samples shows NKG2A expression is strongly associated with tumor expression of 5T4 or TROP2, supporting inclusion of the NKG2A arm in CAPTN-3 designs NKG2A arm significantly contributes to IM1240...Read more
Publication in key market advances NewcelX's global IP strategy across Asia and supports the Company's expanding position in neurology and metabolic diseases ZURICH, Dec. 11, 2025 /PRNewswire/ -- NewcelX Ltd. (Nasdaq: NCEL), a next-generation biotechnology company developing advanced cell-therapy and neuroscience-driven therapeutics, today announced the publication of a major international patent application in China covering a...Read more
6-month commercial pilot demonstrated increasing demand among prescribers Expansion plan includes doubling the number of sales reps, a new GoodRx partnership, and enhanced digital marketing campaign Additional clinical sites in ongoing babesiosis treatment trials will be initiated in light of FDA feedback regarding Company’s breakthrough therapy designation request WASHINGTON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- 60 Degrees...Read more
CAMBRIDGE, Mass. / Dec 11, 2025 / Business Wire / Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today announced the entry into definitive agreements for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 426,390 shares originally issued in...Read more
Patients treated with 0.05% urcosimod demonstrated directionally favorable improvements in nerve fiber count and fiber length, trends not observed in the placebo group These findings suggest that urcosimod may have a positive impact on corneal nerve health in patients with neuropathic corneal pain Corneal nerve imaging data from the Phase 2 NCP trial were analyzed using in vivo confocal microscopy LONDON and NEW YORK, Dec. 11, 2025...Read more
BOSTON, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that it will host a live conference call and webcast on Thursday, December 11 at 8:00 a.m. ET to disclose preliminary data from its exploratory Phase 2 trial of setmelanotide in patients with...Read more
CAMBRIDGE, Mass., Dec. 10, 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 the appointment of Ron Squarer to its Board of Directors. "We welcome Ron to our Board of Directors, where his personal dedication to advancing oncology therapeutics, demonstrated success in...Read more
Phase 1 dose escalation trial of monotherapy IDE574 expected to begin in 1Q 2026 Targeting to present preclinical data detailing pharmacologic profile and evidence of anti-tumor activity in solid tumor models at a medical conference in 1H 2026 SOUTH SAN FRANCISCO, Calif., Dec. 10, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, announced the submission of an...Read more
Ragistomig is a 4-1BB X PD-L1 bispecific antibody, designed to treat patients with advanced or metastatic solid tumors, including those who have relapsed or are refractory to checkpoint inhibitors, a multi-billion dollar pillar of cancer care, hampered by widespread resistance The study achieved its objective, as the new Q6W extended dosing interval produced encouraging anti-tumor efficacy and immunological data in prior...Read more
THE WOODLANDS, Texas, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the publication of preclinical data validating Acyl-CoA Synthetase 5 (ACSL5) as a target for obesity and chronic weight management. The paper, titled “Acyl-CoA Synthetase 5 knockout and inhibitors protect against diet-induced obesity in mice by activating the ileal brake,” was published online in the Journal of the...Read more
MALVERN, Pa., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that Dr. Shankar Musunuri, Chairman, CEO, and Co-founder, will present at the Oppenheimer Movers in Rare Disease Summit taking place at the Sofitel New York on Thursday, December 11, 2025.“For the second year in a row, we will join leaders advancing...Read more
CONCORD, Calif. / Dec 10, 2025 / Business Wire / Cerus Corporation (Nasdaq: CERS) announced today that it has entered into a group purchasing agreement with Blood Centers of America (BCA), the largest blood supply cooperative in the U.S. BCA member blood centers produce approximately half of the U.S. platelet and cryoprecipitate supply. The agreement covers Cerus’ entire INTERCEPT product line. Under this agreement, Cerus will partner with...Read more
Prospective clinical data show NexoBrid® removes embedded particles in friction and blast wounds, reducing pigmented wound surface by >90% Traumatic tattoos form when dirt, metal, or explosive residue becomes permanently embedded in the skin; findings support further evaluation in acute trauma settings YAVNE, Israel, December 10, 2025 -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for...Read more
SOUTH SAN FRANCISCO, Calif. / Dec 10, 2025 / Business Wire / Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, announced the publication of a summary of early-stage clinical studies of its Phase 3 lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in a patient’s own red blood cells), in pulmonary and...Read more
SAN MATEO, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that Ascletis Pharma Inc. issued a December 10 statement that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for denifanstat for the treatment of...Read more
Company will host conference call and live webcast to review and discuss the data at 8:00 am ET NORWOOD, Mass., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP), a clinical stage company focused on oncology and obesity, announced the Company’s plan to release results of its Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) study of CRB-913 prior to the market open on Thursday,...Read more
First patient from TNBC trial demonstrated 76% tumor volume shrinkage with corresponding reductions in circulating tumor cells (CTC) and clusters Reinvigoration of immune system + turning cold tumors hot Preliminary ex-vivo data in HER2+ patients demonstrates immune reinvigoration and reductions in CTC and clusters SYDNEY, Dec. 10, 2025 /PRNewswire/ -- Kazia Therapeutics Limited ("Kazia" or the "Company") (NASDAQ: KZIA) today...Read more
MDNA11 demonstrates durable anti-tumor activity in phase-2 eligible expansion cohorts, enriched for immune checkpoint resistant melanoma, MSS endometrial cancer, MSI-H and TMB-H cancers, in each case exceeding objective response rate (ORR) benchmarks in these difficult to treat populations In the monotherapy expansion cohorts, irrespective of tumor type, patients treated with MDNA11, as the next treatment following progression on...Read more
CHICAGO, Dec. 10, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology (NYSE American: MAIA) – The treatment paradigm for advanced non-small cell lung cancer (NSCLC) is undergoing another shift. After a decade of targeted therapies and checkpoint inhibitors (CPIs) dominating headlines, MAIA believes that a new therapeutic class—telomere-targeting agents—is emerging for the population with substantial unmet medical need: patients without actionable...Read more
Test-Controls & Reference Materials for Labs & Test-Makers MISSISSAUGA, Ontario, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces the commercial launch of QAPs™ quality assessment products and availability of QUANTDx™ reference materials to support antigen or molecular tests for H3N2 strains of seasonal Influenza A...Read more
Company addresses FDA requests regarding formulation excipient Global site start-up activities continue, with first-patient-in for registrational Phase 1b study targeted for Q1 2026, subject to FDA feedback HUNTSVILLE, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina” or the "Company") (NYSE American: SER), a clinical-stage biotechnology company advancing its lead Investigational New Drug ("IND")...Read more
Developed and evaluated specifically for women, DARE to PLAY™ Sildenafil Cream is a first-of-its-kind female arousal cream, a non-hormonal topical cream shown in clinical studies to increase genital blood flow in 10–15 minutes, and improve arousal sensations based on clinically-validated endpoints. Market introduction of DARE to PLAY™ is expected to mark a breakthrough in women’s sexual health and represents important progress toward...Read more
VTP-1000, an antigen-specific immunotherapy to treat celiac disease, showed a dose-dependent pharmacological effect in the SAD portion of the trial VTP-1000 was well-tolerated with no treatment-related SAEs The MAD portion of the trial, which includes a gluten challenge, is ongoing GERMANTOWN, Md., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS) (“Barinthus Bio,” or the “Company”), an immunology and...Read more
Platform Poised to Expand into Joint and Cartilage Repair HOUSTON, Dec. 10, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics” or the “Company”), 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 that it has submitted a new...Read more
Results support the potential of PMN310 to improve outcomes by selectively targeting oligomers and avoiding binding to monomer and plaque ProMIS on track to complete enrollment in PRECISE-AD trial in Alzheimer’s disease by end of 2025 with planned Q2 2026 interim readout Cambridge, Massachusetts, Dec. 10, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the...Read more
| Company | Change | Last Trade |
|---|---|---|
| Ascendis Pharma | 10.26 4.88 | $220.42 |
| Ligand Pharmaceuticals | 6.42 3.51 | $189.55 |
| Vertex Pharmaceuticals | 6.11 1.37 | $452.04 |
| United Therapeutics | 5.48 1.12 | $493.99 |
| Bolt Biotherapeutics | 4.88 871.43 | $5.44 |
| Celcuity | 4.48 4.45 | $105.25 |
| Vera Therapeutics | 3.78 8.21 | $49.80 |
| Nektar Therapeutics | 3.58 7.00 | $54.70 |
| Protagonist Therapeutics | 3.10 3.36 | $95.35 |
| Galecto | 2.99 10.31 | $32.00 |
| Jazz Pharmaceuticals | 2.61 1.58 | $167.50 |
| Cytokinetics | 2.58 4.25 | $63.35 |
| Soleno Therapeutics | 2.51 5.07 | $52.00 |
| Cogent Biosciences | 2.07 5.17 | $42.11 |
| Kymera Therapeutics | 1.87 2.13 | $89.68 |
Recursion is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological and chemical datasets...
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ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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