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

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 monoclonal antibody. The study is sponsored by and being conducted at the Mays Cancer Center, a National Cancer Institute (NCI)-designated Cancer Center and part of The University of Texas at San Anton

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

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Biogen’s litifilimab (BIIB059) for cutaneous lupus erythematosus (CLE), a chronic autoimmune skin condition. This designation aims to expedite the development and review of medicines for serious conditions. The FDA based its decision on comprehensive data, including findings from the Phase II LILAC study. Results from this trial indicated that litifilimab reduced skin disease activity in patients with CLE

Februari 2, 2026 - Immedica today announces the results from a phase 3 clinical study Loargys® in children below 2 years of age with arginase 1 deficiency (ARG1-D). ARG1-D is an autosomal recessive urea cycle disorder (UCD) characterized by chronic hyperargininemia, leading to progressive spasticity, developmental delay, and seizures. Available treatment before Loargys involved a strict protein-restricted diet, essential amino acid supplementation, and symptom management. Despite these interven

Feb. 2, 2026 -- Global pharma major Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced the launch of Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, in the United States, following the approval for its Abbreviated New Drug Application (ANDA) from the U.S. FDA. The product was developed in partnership with Pharmascience Inc. Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg are bioequivalent to Sprycel® Tabl

Feb. 2, 2026 -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today announced that the U.S Food and Drug Administration's (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to IFx-2.0 for the treatment of stage IIB to stage IV cutaneous melanoma. The ODD designation was based on data from the Company's previously completed Phase