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

Feb. 3, 2026 -- Imbed Biosciences, a leader in advanced synthetic antimicrobial and tissue regeneration solutions, today announced a strategic investment from BioLab Holdings Inc. This investment is set to significantly expand Imbed Biosciences' reach within the US market, particularly in the MD office setting, and accelerate the development of its proprietary SAM™ Antimicrobial Technology platform to minimize wound care complications. "The strategic investment from BioLab Holdings marks a pivo

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

Sensorion has announced a €60m ($71.9m) reserved offering through the issuance of 214,285,714 new ordinary shares at €0.28 per share to advance the development of its gene therapy pipeline. The financing includes a €20m strategic investment from Sanofi and €40m from existing and new investors such as Artal (advised by Invus), Redmile Group, Cormorant Asset Management, Sofinnova Partners, Sphera Healthcare, and Coastlands Capital. Settlement of the offering is expected around 30 January 2026, s

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

- SanegeneBio grants exclusive worldwide license to one of its RNAi programs to Genentech - SanegeneBio to receive $200 million upfront payment and will be eligible to receive development and commercialization milestone payments, totaling up to $1.5 billion, plus tiered royalties - Genentech will be responsible for the subsequent clinical development and commercialization globally Feb. 2, 2026 -- SanegeneBio, a clinical-stage biotechnology company developing innovative RNAi therapeutics, today

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

Collaboration unites Repertoire's DECODE™ platform to develop T cell targeted immune medicines with Lilly's commitment to bringing transformative medicines to patients with unmet need Jan. 29, 2026 -- Repertoire® Immune Medicines, a biotechnology company pioneering the discovery and development of programmable T cell targeted immune medicines, announced today that it has entered a strategic collaboration with Eli Lilly and Company ("Lilly") to develop tolerizing therapies for multiple autoimmun