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Stock impact report

Rhythm Stock Up as FDA Accepts Obesity Drug sNDA for Younger Kids [Yahoo! Finance]

Rhythm Pharmaceuticals, Inc. (RYTM) 
Last rhythm pharmaceuticals, inc. earnings: 3/8 08:12 am Check Earnings Report
US:NASDAQ Investor Relations: ir.rhythmtx.com
Company Research Source: Yahoo! Finance
its only marketed drug, Imcivree (setmelanotide), to treat obesity in children as young as two years old, under the Priority Review pathway. A filing designated as a Priority Review reduces the review period to four months. A final decision from the FDA is expected on Dec. 26, 2024. Imcivree, an MC4R agonist, is already approved in the United States and EU for chronic weight management in adult and pediatric patients aged six years and older. The eligible patient population includes those with monogenic or syndromic obesity due toBardet-Biedl syndrome (BBS) or pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. Rhythm's sNDA is looking to expand the eligible patient population for the drug by lowering the minimum required age to receive Imcivree treatment to two years in the United States. In July 2024, the drug's label was expanded in the EU to include children aged two years with obesity due to BBS o Show less Read more
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