DPTX3186, a first-in-class beta-catenin condensate modulator, received Orphan Drug Designation and Fast Track Designation from FDAClinical entry validates condensate modulator discovery platform and its potential to address historically intractable targets through a novel mechanism BOSTON, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Dewpoint Therapeutics, Inc., a clinical-stage biotechnology company pioneering condensate-modulating therapeutics, today announced that the first patient has been dosed in

Feb. 4, 2026 -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on developing new products for rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its novel oral therapy targeting a fatal form of heart disease in Duchenne muscular dystrophy (DMD) patients. The FDA's Fast Track program facilitates the development and expedites the review of a drug designed to treat a serious or life-thre

February 4, 2026 Biodexa Announces Exclusive License of Otsuka’s OPB-171775, a potent Phase 1 ready Molecular Glue for GIST Novel Mechanism of Action Shown to be Effective in TKI Resistant PDX Models Cardiff, UK – February 4, 2026 – Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of rare diseases with unmet medical needs, today announced the closing of an exclusive license with Otsuka Pharmac

Affinia Therapeutics (“Affinia”), an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for AFTX-201, an investigational genetic medicine for the treatment of BAG3 DCM. “We are grateful to the FDA for the timely review of our IND application f

Tr1X, a clinical-stage autoimmune and inflammatory disease company developing Type 1 regulatory T (Tr1) cell therapies, today announced the first clinical data from its ongoing Phase 1 study of TRX103 in patients with hematologic malignancies undergoing HLA-mismatched hematopoietic peripheral stem cell transplantation (HSCT), presented at the 2026 ASTCT/CIBMTR Tandem Meetings. The data represents the first clinical results for TRX103, an investigational, off-the-shelf engineered Tr1 cell therap

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, has granted approval for its clinical trial application (CTA) for Study SRP-1005-101, also known as INSIGHTT. Sarepta expects to initiate this first-in-human clinical trial of SRP-1005 (formerly ARO-HTT) in the second quarter of 2026. SRP-1005 is an investigational small interfering RNA (siRNA) therapeu

Feb. 4, 2026-- Kodiak Sciences Inc. (Nasdaq: KOD), a precommercial retina focused biotechnology company committed to researching, developing and commercializing transformative therapeutics, announced today participation at the virtual Angiogenesis (Angiogenesis, Exudation, and Degeneration) annual meeting on February 7, 2026. Dr. Sumit Sharma, retina and uveitis specialist at the Cole Eye Institute, will present first-time end-of-study clinical results, including Week 24 data, from the Phase 1b

Milestone validates the clinical potential of BSI-082 as a synergistic combination partner for antibody-drug conjugates (ADCs). NEWARK, DE, UNITED STATES, February 3, 2026 / EINPresswire.com / -- Biosion , Inc. (“Biosion”), a global, clinical-stage biotechnology company developing innovative antibody-based therapeutics, today announced that the first patient has been dosed in a Phase 1a/1b Investigator-Initiated Trial (IIT) evaluating BSI-082 , a highly differentiated, fully human anti-SIRPα mon

Initiation of the IIMPACT study follows promising Phase 1 results where Restem-L demonstrated clinically meaningful efficacy and a significant reduction in steroid use within 6 months in Idiopathic Inflammatory Myopathy (IIM) Interim readout expected in 2H 2026 Feb. 03, 2026 -- RESTEM – a clinical-stage biotechnology company that develops off-the-shelf, next-generation cell therapies designed to modulate the immune system, today announced it had dosed the first patient in the Phase 2/3 IIMPACT

GTB-5550 Phase 1 dose escalation basket trial expected to initiate mid-2026 Phase 1 protocol allows multiple solid tumor types known to express B7-H3 Unaudited proforma cash balance as of January 31, 2026 of approximately $9 million anticipated to extend cash runway through Q4 2026 Feb. 03, 2026 -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE® natural killer (NK