RYTM - FDA rejects Rhythm Pharma's application for its Imcivree medicine to treat Alström syndrome

Rhythm Pharmaceuticals (NASDAQ:RYTM) on Thursday said the U.S. FDA had rejected the company's supplemental new drug application (sNDA) for its Imcivree medicine for the treatment of rare genetic disease Alström syndrome. Rhythm said it plans to reevaluate potential paths forward in Alström syndrome in the U.S. RYTM also said the U.S. FDA had approved its other sNDA for Imcivree to be used in patients with Bardet-Biedl syndrome, another genetic condition that can cause problems with obesity and can lead to intellectual impairments. RYTM said Imcivree was now available for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to Bardet-Biedl syndrome. The FDA approval was based on late-stage trial results that showed statistically significant reductions in weight and hunger in patients with Bardet-Biedl syndrome. RYTM stock earlier closed +13% at $3.90.

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FDA rejects Rhythm Pharma's application for its Imcivree medicine to treat Alström syndrome