RYTM - Rhythm Pharma gains as FDA issues breakthrough status for weight loss agent

• Commercial-stage biotech Rhythm Pharmaceuticals ( NASDAQ: RYTM ) added ~5% pre-market Tuesday after announcing that the FDA issued Breakthrough Therapy Designation for its lead candidate setmelanotide as a treatment for hypothalamic obesity.
• Setmelanotide, marketed as Imcivree, is already indicated in the U.S. for weight management in conditions including the rare genetic disorder Bardet-Biedl syndrome.
• Hypothalamic obesity is a rare disorder characterized by extreme obesity resulting from a damaged hypothalamus in the brain.
• With its Breakthrough Therapy designation, the FDA aims to speed up the development and review of treatments targeted at serious or life-threatening conditions.
• The designation allows a company to receive intensive regulatory guidance from the FDA during drug development with potential eligibility for priority review.
• The FDA decision is based on data from a Phase 2 16-week clinical trial for the candidate.

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