- FDA RMAT designation recognizes encouraging early data from Opus’ Phase 1/2 trial in patients with LCA5, an ultra-rare inherited retinal disease May 06, 2025 -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and other ophthalmic disorders, announced today that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to

- Data reveal WTX-921 is efficacious in a mouse colitis model, resulting in reduced tissue damage and inflammatory cytokine production - - Findings offer a more detailed understanding of WTX-921’s anti-inflammatory impact on the immune landscape in the inflamed colon - May 05, 2025 -- Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the bo

UBX1325 demonstrated vision gains that were comparable and statistically non-inferior to aflibercept at week 36 in a difficult-to-treat DME patient population UBX1325 generally outperformed aflibercept in a pre-specified subgroup of patients entering the study with CST Company to explore strategic alternatives to advance UBX1325, Tie2/anti-VEGF bispecific, and Tie2 agonistic antibody assets and reduce operational cash burn May 05, 2025 -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a bi

May 01, 2025 -- OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing urcosimod (formerly called OK-101) to treat NCP, an ocular condition associated with chronic and often severe pain but without an FDA-approved therapy, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to urcosimod for the treatment of neuropathic corneal pain (NCP). Fast Track designation by the FDA is granted to facilitate the

May 01, 2025 -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced patent number 12,274,692 was issued on April 15, 2025 by the United States Patent and Trademark Office (USPTO) covering a novel method of treating alcohol-related diseases and opioid-related disorders using AD04 in genetically identified patients. Thi

Study ANAVEX3-71-SZ-001 successfully completes enrollment with a total of 71 participants Both Part A (16 participants) and Part B (55 participants) of the placebo-controlled Phase 2 study fully enrolled Top line data expected in the second half of 2025 May 01, 2025 -- 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, neurodeve

May 01, 2025 -- Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today announced favorable data from a Phase 1 single- and multiple-ascending dose (SAD/MAD) trial of DT-168 in healthy volunteers, which will be presented on May 2, 2025 at Eyecelerator @ Park City 2025, an event backed by the American Academy of Ophthalmology highlighting industry advancements and innovative new products disrupting ey

May 01, 2025 -- BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the first patient enrolled in the Phase III randomized procedure placebo-controlled double-blind CardiAMP HF II clinical trial of the Company’s lead autologous cell therapy program for the treatment of heart failure at BayCare Morton Plant Hospital in Clearwater, Florida. “We are excited to lead enrollment in the C

80% of EVX-01 vaccine targets triggered a tumor-specific immune response, a substantially higher frequency than what has been reported for other similar vaccine candidates The data underscores the precision of Evaxion’s AI-Immunology™ platform in selecting therapeutically relevant vaccine targets New findings show EVX-01 inducing a robust and durable immune response, further enhanced by booster immunizations The ongoing phase 2 trial with EVX-01 remains on track for two-year data readout in the

Phase 2b study evaluating diagnostic performance of 18F-RAD101 for suspected recurrent brain metastases from solid tumors of different origins Underscores Radiopharm’s commitment to developing transformative oncology radiopharmaceuticals April 28, 2025 -- Radiopharm Theranostics (ASX:RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced th