IND clearance enables U.S. clinical development of KT501, a first-in-class CD19xBCMAxCD3 tri-specific T-cell engager for B cell–mediated autoimmune diseases, building on safety data generated in the ongoing Australian first-in-human study in rheumatoid arthritis. Sept. 3, 2026 -- Kali Therapeutics, a clinical-stage biotechnology company pioneering next-generation immune-resetting and multi-specific therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the compa

The collaboration will support Genprex's AAV-based diabetes gene therapy candidate for IND-enabling preclinical studies and cGMP clinical manufacturing. Sept. 1, 2026 -- Andelyn Biosciences, a leading contract development and manufacturing organization, announced today that Genprex, Inc. has selected Andelyn to support scale-up manufacturing for its diabetes gene therapy program. Genprex's diabetes gene therapy candidate is designed to deliver the Pdx1 and MafA genes directly to the pancreas v

Aug. 31, 2026 -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it has entered into a binding term sheet for a global settlement and license agreement with BioMarin Pharmaceutical Inc. (“BioMarin”) related to the sale of YUVIWEL® and navepegritide-related products. The binding term sheet provides the terms and conditions upon which the companies agree to resolve all litigation and disputes between the companies. Under the terms, BioMarin has agreed to grant Ascendis a non-exclusive, worldwi

- Expected to enroll approximately 4,600 participants with obesity or overweight across two pivotal trials (AURORA-1 and AURORA-2) in the U.S., Europe, and Canada. - Global Phase III clinical program to investigate efficacy and safety of three maintenance doses (20 mg, 40 mg, and 60 mg) over 72 weeks in participants with obesity or overweight without type 2 diabetes (AURORA-1) and with type 2 diabetes (AURORA-2). - Topline data from the AURORA Phase III clinical program are expected in the thir

Roche's Genentech unit inked an agreement with DualityBio, potentially exceeding $1 billion, to develop next-generation antibody-drug conjugates (ADCs) built on the latter's proprietary platform. The collaboration announced Friday aims to integrate DualityBio’s ADC payload and clinical development expertise with Roche’s oncology capabilities to target tumours that do not respond to topoisomerase inhibitor-based ADCs. DualityBio CEO John Zhu said that with topoisomerase inhibitor-based ADCs mov

Through its DualityBio deal, Roche’s Genentech hopes to create antibody-drug conjugates with payloads that can circumvent growing cancer drug resistance. Just days after announcing a deal with a South Korean company, Roche’s Genentech is now partnering with Shanghai-based DualityBio to advance next-generation antibody-drug conjugates for cancer. Under the terms of the deal, Genentech will pay $45 million upfront and set aside up to more than $1 billion in development, regulatory and commercial

Aug. 28, 2026 -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that it has entered into a securities purchase agreement with new and existing healthcare-focused institutional investors to raise up to approximately $50.0 million in gross proceeds, including initial upfront funding of approximately $30.8 million and up to an additional approximately $19.2 million upon

Sept. 1, 2026 -- Pyrotech Therapeutics ("Pyrotech" or the "Company"), a clinical-stage biopharmaceutical company pioneering innate immune modulation and pyroptosis-targeted therapies, announced that the first healthy volunteer has been dosed in the Phase 1 clinical study of PTT-121, its novel gasdermin D (GSDMD) inhibitor. This marks a pivotal milestone for PTT-121 as the world's first selective GSDMD inhibitor to advance into human clinical testing, breaking the previous characterization of GSD

Together with the previously announced Talicia® strategic divestiture, the acquisition from Ferring of commercialization rights to two larger, proprietary, established gastrointestinal (GI) FDA-approved drugs that together generated approximately $37.5 million in 2025 net sales, completes a major strategic repositioning of RedHill's commercial GI business The divestiture of Talicia and the acquisition of the new GI products from Ferring create a catalyst for commercial growth through a material

New single-arm, open-label data extend the body of evidence supporting consistent clinical benefit and safety with Camzyos, adding to the longest-running clinical development experience for a cardiac myosin inhibitor (CMI) in symptomatic oHCM Additional presentations at ESC Congress build upon the established effectiveness and safety pro Camzyos in real-world settings Bristol Myers Squibb (NYSE: BMY) today presented results from the EXPLORER-LTE cohort of the MAVA-LTE study (NCT03723655) in a l