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 stock. The awards are subject to all... 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 CHARLOTTE, N.C., Dec. 12, 2025 (GLOBE... 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 most reported bacterial STI in the... 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 candidate, EB06 (an anti-CXCL10 monoclonal... 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 review in the EU for blarcamesine... 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 thereof), Series F warrants... 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 December 10, 2025. Mr. Berkley will... 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 Company has begun the process... 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 foralumab, a fully human,... 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 comorbidities such as chronic kidney disease... 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™ radiodermatitis pivotal... 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 antibody drug conjugates
Data supports... 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, for the treatment of symptomatic... 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 (5-methoxy-2-aminoindane, also known as CMND-100),... 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 (I&I) diseases; a small molecule... 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 solution, a dye- and preservative-free... 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 results from the Asian subset (n=488)... 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 (GLOBE NEWSWIRE) -- Relay Therapeutics,... 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 approved, Europe recognizes and has... 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 September 2025, having exercise... 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 pathogen.
Gonorrhea is the second most reported bacterial... 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 week. The independent study authors... 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" or the "Company") (NASDAQ: ANIX),... 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 Holdings Limited (“Cycle”)... 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 of $40.00 per share, before... 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 antagonist candidate for the proposed... 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 the underwriters a 30-day option... 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 sold and issued upon the full exercise... 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. Food and Drug Administration (FDA)... 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, 2025 (GLOBE NEWSWIRE) -- Tenaya... 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 gedatolisib triplet and 7.1 months... 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 ultrasensitive, tumor-informed... 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 in the Company’s THIO-104... 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 (GLOBE NEWSWIRE) -- OKYO Pharma... 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 patented, FDA-cleared dr... 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 mucoadhesion successes.
Following... 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 colorectal cancer who have completed... 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 diseases, today announced the... 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 developing transformative therapeutics... 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 Drug Administration ("FDA") has... 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 presentations, including two oral presentations,... 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 Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW)... 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 ELI-002 7P to generate a broader, more... 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 planned discussion with the FDA leading... 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 Leader (KOL) seminar VANCOUVER,... 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 Study Design with INT230-6 plus standard... 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 been granted lab licenses... 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 calendar year 2027
Brepocitinib Phase... 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 and pediatric patients with recessive... 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 11 at 8:00 a.m. BOSTON,... Read more
