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How the FDA's Priority Review for Setmelanotide Could Shape Rhythm Pharmaceuticals' (RYTM) Rare Disease Strategy
Rhythm Pharmaceuticals announced that the FDA has accepted for filing its supplemental New Drug Application for setmelanotide to treat acquired hypothalamic obesity and granted Priority Review, targeting a decision by December 20, 2025.
The expedited review signals setmelanotide’s potential to address an unmet medical need and may accelerate commercial opportunities in a new therapeutic indication.
We'll examine what the FDA's Priority Review for setmelanotide means for Rhythm's growth...