FDA
Patent Enhances IP Estate for Lead Asset; Combined with Anticipated Biologics Exclusivity, Market Protections Extend Over 20 Years Excerpt from the Press Release: PRINCETON, N.J., Jan. 22, 2026 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills…
Company to present at J.P. Morgan Healthcare Conference on Tuesday, Jan 13, 2026 Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–Epicrispr, a clinical-stage company pioneering gene-modulating therapies, today reported early clinical data from its ongoing first-in-human, open-label study evaluating EPI-321, an investigational epigenetic therapy for facioscapulohumeral muscular dystrophy (FSHD). Epicrispr holds the first and only…
GT Biopharma targets a portion of the estimated $362 billion global solid tumor market Preliminary, unaudited cash balance of approximately $7 million as of December 31, 2025 anticipated to extend cash runway into Q3 2026 Excerpt from the Press Release: SAN FRANCISCO, CALIFORNIA, Jan. 15, 2026 (GLOBE NEWSWIRE) — GT Biopharma, Inc. (the “Company”) (NASDAQ:…
73% of trial participants (11/15 participants) improved on the Overall Cutaneous Venous Malformations Investigator Global Assessment (Overall cVM-IGA) at Week 12; 67% of trial participants (10/15 participants) rated as “Much Improved” (+2) or “Very Much Improved” (+3) on the Overall cVM-IGA at Week 12 Achieved statistical significance on multiple pre-specified clinician-reported and patient-reported efficacy endpoints,…
Excerpt from the Press Release: DOVER, Del. & EPALINGES, Switzerland–(BUSINESS WIRE)–Pilatus Biosciences Inc., a biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for PLT012, a first-in-class anti-CD36 monoclonal antibody, to enter clinical…
Company to launch only current registration trial with an immunotherapy in first-line pancreatic cancer in first half of 2026 Trial design allows flexibility to include an experimental arm with checkpoint inhibitor combination Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today…
First Gene Therapy Trial for Angelman Syndrome -Orphan Drug Designation Granted for MVX-220 Excerpt from the Press Release: MIDDLETON, Mass., Nov. 6, 2025 /PRNewswire/ — MavriX Bio, a clinical-stage biotechnology company focused on the development of transformative genetic therapies for Angelman syndrome (AS), today announced that the first patient has been dosed in the Phase 1/2…
Phase 2 clinical trial underway with first patient dosed in October to support a clear path to Phase 3 based on previous alignment with FDA Patients randomized to either 10 or 20 mg/kg of muzastotug, in combination with KEYTRUDA with up to 30 patients per arm Company anticipates trial completion in early 2027, and potential updates in…
– Second generation pulsed field ablation system will be evaluated in paroxysmal and persistent atrial fibrillation patients to gain FDA approval – Excerpt from the Press Release: LAUSANNE, Switzerland and SAN DIEGO, Sept. 18, 2025 /PRNewswire/ — Argá Medtech, developers of the Coherent Sine-Burst Electroporation™ (CSE™) System, a next-generation pulsed field ablation (PFA) system for treating…
Excerpt from the Press Release: CRANBURY, N.J.–(BUSINESS WIRE)–Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company’s pivotal Phase 2 trial of…