Phase IIb data of Metsera Inc.’s lead GLP-1 receptor agonist, MET-097i, showed significant weight loss and good tolerability, supporting a phase III start later this year, and validating Pfizer Inc.’s decision a week ago to buy the obesity-focused company for $7.3 billion.
Opus Genetics Inc. will be sitting down with the U.S. FDA to talk about positive three-month data from the pediatric cohort of its ongoing phase I/II trial called OPGx-LCA5-1001 – partially funded by the agency – evaluating OPGx-LCA5, a gene augmentation therapy for ultra-rare Leber congenital amaurosis type 5 (LCA5). The affliction is a severe form of retinal dystrophy that renders babies blind in the first year of life.
Anaptysbio Inc. said it intends to split into two publicly traded companies – one for developing a pipeline, the other for managing royalties – each with its own business model. The royalty company will hold and manage the rights to big-earning Jemperli (dostarlimab) royalties from collaborator GSK plc, along with imsidolimab milestones and royalties from Vanda Pharmaceuticals Inc.
Despite down-to-the-wire negotiations, the odds are that parts of the U.S. government will shut down at midnight Sept. 30, as Senate Democrats refused to support a seven-week, clean continuing resolution already passed by the House to keep the government funded while Congress hammers out fiscal 2026 spending bills.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Abbvie, Amneal, Crinetics, Eli Lilly, Regeneron, Sanofi.
Biopharma happenings, including deals and partnerships, and other news in brief: Fractyl Health, Harrow, Melt, N4, Ocuvex, Onconetix, OSE, Sanofi, SRI, Theratechnologies.