FDA extends review period for Rhythm’s Imcivree

10 November 2025

The US Food and Drug Administration (FDA) has extended by three months the review period for the supplemental New Drug Application (sNDA) for Boston, USA-based Rhythm Pharmaceuticals’ (Nasdaq: RYTM) Imcivree (setmelanotide) for the treatment of acquired hypothalamic obesity.

The FDA notified the company that the Prescription Drug User Fee Act (PDUFA) goal date has been extended from December 20, 2025 to March 20, 2026. Rhythm’s stock dipped 6.2% to $98.43 per share at market open on November 7 following news of the PDUFA delay.

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