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

Ultragenyx has resubmitted its approval request for a rare disease gene therapy after the FDA rejected it last summer. UX111 is an AAV gene therapy designed to treat Sanfilippo syndrome type A. The company is again seeking accelerated approval using a novel biomarker, part of a push by biopharma to test the FDA’s appetite to ease access for rare disease drugs. But in July, the agency turned down the drug after an inspection of a manufacturing facility raised concerns. Ultragenyx said Friday th

Jan. 30, 2026 -- Kos Biotechnology Partners ("Kos"), a global life sciences investment firm, today announced the closing of a financing round in Epikast, a premier provider of technology-enabled commercial and clinical services for the biopharmaceutical industry. This transaction marks the first investment from Kos' inaugural fund, which is focused on a broad range of investment stages, including the seeding and scaling of high-impact life sciences platforms. Kos led the round with significant

New six-month results from the Vyepti® (eptinezumab) 12-month, real-world INFUSE study presented at the 2026 Headache Cooperative of the Pacific (HCOP) Annual Conference, Ojai, California1 The INFUSE study includes adults with migraine who had failed at least one preventive anti-calcitonin gene–related peptide (aCGRP) treatment1 Clinically meaningful improvements reported across migraine frequency, responder rates and other patient-reported outcomes in adults switching to eptinezumab1 Jan. 30,

-Incyte (Nasdaq:INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). "Today’s positive CHMP opinion is an important step

Data identify nuclear PD-L1 as a previously unaddressed driver of immunotherapy resistance and metastatic progression Jan. 30, 2026 -- Kazia Therapeutics (NASDAQ: KZIA), an oncology-focused pharmaceutical company developing novel therapies for difficult-to-treat cancers, today announced compelling preclinical and translational data supporting the development of NDL2, a potentially first-in-class protein degrader that is designed to selectively eliminate nuclear PD-L1, a previously unrecognized

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

Jan. 29, 2026 -- MicuRx Pharmaceuticals, Inc. ("MicuRx"), a clinical-stage biopharmaceutical company focused on developing novel anti-infective therapies for drug-resistant bacterial infections, recently announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for MRX-5, enabling the company to initiate a Phase 2a clinical trial in patients with Mycobacterium abscessus pulmonary disease. M. abscessus pulmonary disease is a serious an

Jan. 29, 2026 -- Innovative Molecules GmbH, a German clinical stage biotech company focused on development of novel agents in the field of herpes-mediated diseases, today announced the successful completion of its Phase 1 clinical development program and the transition into Phase 2 for its oral selective helicase primase HSV inhibitor adibelivir (IM-250). The Phase 1 clinical development program included the following clinical trials: IM-101: Phase 1a single-ascending dose study in healthy volu

Jan. 28, 2026 -- WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), and Sinorda Biomedicine today jointly announced a strategic collaboration for the development and manufacturing of SND006, a novel bispecific antibody, for the potential treatment of inflammatory bowel disease (IBD) and other autoimmune diseases. Under the agreement, Sinorda Biomedicine will leverage WuXi Biologics' extensive experience and manufacturing capabiliti