Rhythm Pharmaceuticals Inc RYTM:NASDAQ

Last Price$4.30NASDAQ Previous Close - Last Trade as of 4:00PM ET 7/01/22
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Rhythm Pharmaceuticals Says FDA Extends Review Period for Bardet-Biedl, Alstrom Syndrome Treatment Candidate

11:47AM ET 2/24/2022 MT Newswires
Rhythm Pharmaceuticals (RYTM) said Thursday the US Food and Drug Administration extended the review period for the supplemental new drug application for the company's Imcivree setmelanotide drug to treat obesity and hunger control in patients with Bardet-Biedl syndrome or Alstrom syndrome.

The FDA has revised the prescription drug user fee act goal date to June 16 as it needs more time to review additional subgroup analyses of the clinical efficacy data from Rhythm's phase 3 trial, the company said.

Rhythm said it also withdrew the proposed Alstrom syndrome indication from its pending type II variation application to the European Medicines Agency for setmelanotide in order enable the review for Bardet-Biedl syndrome within the planned timeline.

Rhythm shares were down nearly 17% in recent trading.

Price: 6.95, Change: -1.42, Percent Change: -16.97