RYTM - Rhythm Pharma hit by delay in FDA review of label expansion for weight loss therapy

Rhythm Pharmaceuticals (NASDAQ:RYTM) is trading ~8% lower in the pre-market Thursday after the commercial-stage biopharma company announced that the U.S. Food and Drug Administration (FDA) had extended its supplemental New Drug Application (sNDA) for Imcivree. The company has sought the U.S. regulatory approval for Imcivree, also known as setmelanotide, for the treatment of obesity and control of hunger in patients with Bardet-Biedl Syndrome (BBS) or Alström syndrome. However, on Feb. 23, the federal agency has notified that the FDA action date for the decision has been revised to June. 16. While the regulator has not requested new data, it has sought additional subgroup analyses of efficacy data from the company’s Phase 3 pivotal trial in BBS and Alström syndrome. The request was considered as a ‘major amendment’ to the sNDA requiring further time to review, the company said. In addition, Rhythm (RYTM) has decided to pull the proposed Alström syndrome indication from

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Rhythm Pharma hit by delay in FDA review of label expansion for weight loss therapy