Peptide News Digest

#Regeneron

2 stories

Clinical Trials · View digest

Regeneron COURAGE Phase 2: Trevogrumab + Semaglutide Doublet Cuts Lean Mass Loss in Half; Triplet with Garetosmab Pushes to 92.6% Fat-Mass Loss

Regeneron's COURAGE Phase 2 data presented at EASD 2025 continue to drive obesity-pipeline conversations. Semaglutide alone produced 6.5% lean mass loss at 26 weeks; sema + trevogrumab 200 mg cut that to 3.3% (~half), and the triplet with garetosmab (anti-activin A) pushed to 2.0% lean mass loss with 92.6% fat-mass loss. The triplet had higher discontinuation for tolerability. Full COURAGE completion is expected late 2026, with Phase 3 initiation likely 2027.

Regulatory · View digest

FDA Approves Regeneron's Otarmeni Gene Therapy for Inherited Hearing Loss — First Gene Therapy Under National Priority Voucher

The FDA granted accelerated approval April 23 for Regeneron's Otarmeni (lunsotogene parvec-cwha), a gene therapy for certain forms of genetic hearing loss. Otarmeni is the first gene therapy cleared under the FDA's National Priority Voucher program and will be offered to eligible patients at no cost. The approval validates the priority voucher pathway's applicability beyond GLP-1 drugs and establishes regulatory precedent that peptide developers may invoke if the July PCAC meeting produces favorable reclassification recommendations.