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 antibody), in patients with moderat ...

CAMBRIDGE, Mass., Dec. 12, 2025 (GLOBE NEWSWIRE) -- CAMP4 Therapeutics Corporation (“CAMP4” or “the Company”) (Nasdaq: CAMP), a clinical-stage biopharmaceutical company developing a pipeline of regulatory RNA-targeting therapeutics designed to upregulate gene expression with the goal of restoring healthy protein levels to treat a broad range of genetic diseases, today announced that on December 11, 2025 (the “Grant Date”), the Company’s Board of Directors granted non-qualified stock options to purchase an a ...

Core Viewpoint - Anavex Life Sciences Corp. is facing a negative opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) regarding its marketing authorization application for blarcamesine to treat early Alzheimer's disease, and the company plans to request a re-examination of this decision [2][3] Company Overview - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for various CNS disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, and Rett syndrome [1][5] - The company's lead drug candidate, ANAVEX®2-73 (blarcamesine), has completed Phase 2a and Phase 2b/3 clinical trials for Alzheimer's disease and has shown potential in treating other CNS disorders [5] Alzheimer's Disease Context - Alzheimer's disease accounts for 60-80% of all dementia cases globally, representing a significant unmet need for new treatment options to slow disease progression and alleviate the burden on patients and society [4]

Supported by Scientific Evidence Showing Tissue Repair Quality of Company’s ExosomesTORONTO 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 of evaluating potential Israeli production partners ...

Aardvark Therapeutics, Inc. (NASDAQ:AARD) is a clinical-stage biopharmaceutical company developing small-molecule therapeutics designed to suppress hunger for Prader-Willi Syndrome (PWS) and metabolic diseases.Lead compound, oral ARD-101, is in Phase 3 clinical development for hyperphagia associated with PWS, a rare disease characterized by insatiable hunger.On Wednesday, Aardvark Therapeutics dosed the first patient in Australia in its Phase 3 HERO clinical trial assessing ARD-101.Additionally, regulatory ...

– 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 (CKD), obstructive sleep apnea (OSA ...

HAYWARD, Calif.--(BUSINESS WIRE)--Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, inflammatory and autoimmune diseases, today announced the discontinuation of the Phase 3 STAR-221 study, being conducted in partnership with Gilead Sciences, Inc., due to futility. The decision is based on the recommendation from the Independent Data Monitoring Committee (IDMC). ...

Core Insights - Kyverna Therapeutics is advancing its lead CAR T-cell therapy, KYV-101, for autoimmune disorders, with plans for IND filing in Q4 2025 and a BLA submission in H1 2026 [1][3][4] Group 1: Clinical Development - KYV-101 is being explored in multiple autoimmune disorders, including multiple sclerosis and rheumatoid arthritis, through both company-led trials and investigator-initiated studies [1] - Positive interim Phase 2 data from the KYSA-6 trial for generalized myasthenia gravis showed 100% of patients experienced immediate and sustained improvement at 24 weeks, with all patients ceasing immunosuppressive medications [2] - The company anticipates topline data from the registrational trial in stiff person syndrome by early 2026 [3] Group 2: Financial Position - Kyverna reported a net loss of $36.8 million but secured a $150 million loan facility to support its pipeline and pre-launch activities, with an initial draw of $25 million [6] - The company had $171.1 million in cash and equivalents at the end of Q3 2025, which is expected to fund operations until 2027 [6] Group 3: Market Performance - Kyverna's stock has increased by 108% year-to-date, significantly outperforming the S&P 500 Index, which gained 17% [4] - Analysts are bullish on Kyverna, with six out of seven rating the stock as a "Strong Buy" and an average price target suggesting a potential upside of 208% [8]

Core Insights - Syndax Pharmaceuticals' Revuforj® (revumenib) was awarded Best New Drug at the Scrip Awards 2025, highlighting its significance in pharmaceutical development [1][3] - Revuforj is a first-in-class menin inhibitor, recently approved by the FDA for treating relapsed or refractory acute leukemia with specific genetic mutations [2][4] Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative cancer therapies, including Revuforj and Niktimvo™ [22] - The company is committed to advancing cancer care through its pipeline and ongoing clinical trials [22] Product Details - Revuforj is FDA approved for treating relapsed or refractory acute leukemia with KMT2A translocation and acute myeloid leukemia with NPM1 mutation in patients aged one year and older [2][4] - The drug has received Orphan Drug Designation and Fast Track designation from the FDA, indicating its potential in treating serious conditions [6] Clinical Trials and Future Prospects - Multiple clinical trials for Revuforj are ongoing or planned, including studies in combination with standard therapies for newly diagnosed patients [5] - The company aims to unlock the full potential of its pipeline through continued research and development efforts [22]

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) of its global Phase 3 DUBLIN-3 trial eval ...