FDA extends review period for Rhythm’s Imcivree

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.

Rhythm noted that the FDA in October requested additional sensitivity analyses of clinical efficacy data from Rhythm’s Phase III pivotal trial in acquired hypothalamic obesity. No new data were requested. The additional information has been deemed a ‘major amendment,’ which allows for additional time for the FDA to review. The major amendment did not include any information relating to the safety or manufacturing of setmelanotide.