Investor hopes rose sharply for Merus NV’s phase III trials – data should roll out next year – with bispecific antibody petosemtamab after mid-stage results impressed Wall Street in head and neck squamous cell carcinoma. Shares of Utrecht, the Netherlands-based Merus (NASDAQ:MRUS) jumped, too, closing May 23 at $55.14, up $13.54, or 33%, on interim data as of the Feb. 27 cutoff date.
The recent emphasis on eliminating animal studies for preclinical studies of U.S. FDA-regulated products amplifies a long-standing concern, but the U.S. Government Accountability Office raised the question of whether organ-on-a-chip methods are ready to fill the gap.
U.S. FDA commissioner Marty Makary appeared at the May 22 Senate Appropriations Committee with the news the White House proposed an FDA budget for fiscal 2026 of $6.8 billion including user fees. This is a cut of 11.5% that will not likely go over well on Capitol Hill as the FY 2026 budget process unwinds.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abli, Belite, Cel-Sci, Genentech, Innocare, Johnson & Johnson, Moderna.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acelyrin, Alumis, Evofem, Genfit, Ipsen, Multispan, Optinose, Paratek, Pfizer, Pharma 1, SK Bioscience, Synfini.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Accro, Avalyn, EMD Serono, Endeavor, Pepromene, Puretech, Sarepta, Soleno.
Samsung Biologics Co. Ltd. plans to establish a new holding company and to spin off its biosimilar division, Samsung Bioepis Co. Ltd., by October. The corporate restructuring will draw clear lines between Samsung Biologics’ CDMO operations and Samsung Bioepis’ biosimilar business.
Annji Pharmaceutical Co. Ltd.’s rosolutamide (AJ-201, JM-17) achieved positive results in a phase I/II trial in adults with spinal and bulbar muscular atrophy, also known as Kennedy’s disease.
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