FDA extends review of Rhythm's setmelanotide sNDA to March 20, 2026

RHYTHM PHARMACEUTICALS, INC.

New PDUFA goal date March 20, 2026, extended 3 months from December 20, 2025.
FDA requested additional sensitivity analyses of Phase 3 efficacy data; no new data required.
Major amendment classified; no safety or manufacturing issues included in the extension.
Company expresses confidence in data and continues preparations for potential launch.

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