Rhythm pharma down as FDA extends review period for Imcivree label expansion

[Headquarters of US Food and Drug Administration (FDA)]
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Shares of Rhythm Pharmaceuticals (RYTM [https://seekingalpha.com/symbol/RYTM]) fell in the premarket on Friday after the U.S. FDA extended the review period for a marketing application targeting a potential label expansion for its obesity therapy setmelanotide, commercialized as Imcivree.

The company said the FDA has added three months to the review of its supplemental New Drug Application for setmelanotide in acquired hypothalamic obesity, a rare obesity disorder.

Rhythm’s (RYTM [https://seekingalpha.com/symbol/RYTM]) lead asset, setmelanotide, is already approved in the U.S. to treat obesity due to rare genetic disorders such as Bardet-Biedl syndrome. In August, the FDA accepted the company’s sNDA for setmelanotide in acquired hypothalamic obesity for priority review, with a target action date of Dec. 20, 2025.

The review extension will push back the target action date, also called the Prescription Drug User Fee Act (PDUFA) goal date, to Mar. 20, 2026.

Rhythm (RYTM [https://seekingalpha.com/symbol/RYTM]) attributed the delay to the FDA’s request for a new analysis from its Phase 3 pivotal trial backing the sNDA, which the regulator has considered as a ‘major amendment’ to the application. The FDA has not requested additional data, the company noted. [https://seekingalpha.com/pr/20298720-rhythm-pharmaceuticals-announces-fda-extension-of-review-period-for-imcivree-setmelanotide]

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