The potential for TL1A-targeting duvakitug to impact unmet needs of patients with ulcerative colitis (UC) and Crohn’s disease (CD), and to provide antifibrotic effects for a host of other diseases, boosted shares of Teva Pharmaceutical Industries Ltd. and Sanofi SA by 26.5% and 6.7%, respectively, as the partners released what analysts called “best-in-class” results from the phase IIb Relieve UCCD study and prepare for a phase III trial in 2025. Read More
Wall Street must wait until 2025 for data from the higher-dose cohort in Tenaya Therapeutics Inc.’s phase Ib/II study with gene therapy TN-201 for MYBPC3-linked hypertrophic cardiomyopathy (HCM), but shares (NASDAQ:TNYA) closed Dec. 17 at $1.41, down $1.47, or 51%, after results from the first cohort rolled out. Read More
The Danish Medicines Agency is to ask the EMA’s pharmacovigilance committee to investigate a potential increased risk of an acute eye condition in diabetic patients being treated with the glucagon-like peptide-1 receptor agonist Ozempic (semaglutide). Read More
Released from a clinical hold by the U.S. FDA in late September, Biomea Fusion Inc.’s menin inhibitor, icovamenib, has charged ahead to produce positive top-line data from a phase II study in type 2 diabetes (T2D). The data, however, didn’t stop the stock from dropping to near its lowest level of the past 12 months. Read More
Candid Therapeutics Inc. and Epimab Biotherapeutics Inc. have entered a $1 billion research collaboration to discover and develop novel T-cell engager candidates for autoimmune indications. Read More
SK Biopharmaceuticals Co. Ltd. and Proen Therapeutics Co. Ltd. joined hands in a research collaboration to advance up to two preclinical small protein-based radiopharmaceuticals by 2027 – the year SK Biopharmaceuticals aims to “become a leading radiopharma player” worldwide. Read More
Kyorin Pharmaceutical Co. Ltd. has acquired Bayer AG’s phase II obstructive sleep apnea candidate, BAY-2925976, in a deal worth €85M (US$89.3 million) plus sales-based royalties and commercial milestones. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ascendis, Biohaven, Corcept, Edgewise, Foghorn, Immix, Larimar, Menarini, Newamsterdam, Puretech, Reviva, Viridian. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Abliva, Atea, Basilea, BMS, Century, Eli Lilly, Ideaya, Immatics, Innovent, Innoviva , Nimble, Outlook, Pharming, Scisparc. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accord, Arcutis, Celltrion, Checkpoint, CSL, Dermata, Eli Lilly, Galderma, GSK, Lib, Maia, Medigene, Merck, Neurocrine, Organon, Pepgen. Read More
