Why Rhythm Pharmaceuticals Shares Are Falling Today

The FDA has extended the review period for Rhythm Pharmaceuticals Inc's RYTM supplemental marketing application for Imcivree (setmelanotide) for obesity and control of hunger with Bardet-Biedl Syndrome (BBS) or Alström syndrome.
The Prescription Drug User Fee Act (PDUFA) goal date has been revised to June 16, 2022, from March 16.
FDA requested additional subgroup analyses of the clinical efficacy data from Rhythm's Phase 3 pivotal trial in BBS and Alström syndrome.
No new data were requested. The additional information has been deemed a 'major amendment' to the sNDA, which requires extra time to review.
Related: Rhythm Pharma's Highlights Interim Setmelanotide Data In Long Term Genetic Disorder Trial.
The major amendment did not include any information relating to the safety or manufacturing of setmelanotide.
Rhythm also withdrew Alström syndrome indication from its pending Type II variation application to the European Medicines Agency for setmelanotide for obesity and control of hunger in adult & pediatric patients six years of age and older with BBS.
The Company continues to evaluate the next steps relative to seeking marketing authorization for use in patients with Alström syndrome in the European Union.
Price Action: RYTM shares are down 13.30% at $7.26 during the market session on the last check Thursday.