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 prospects and rare disease pipeline.
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Rhythm Pharmaceuticals Investment Narrative Recap
To be a shareholder in Rhythm Pharmaceuticals,…
