Rhythm reports additional positive Phase 3 TRANSCEND data for setmelanotide in hypothalamic obesity

RHYTHM PHARMACEUTICALS, INC.

Placebo-adjusted BMI reduction of 18.8% (N=142); primary endpoint met with -16.4% BMI change on setmelanotide vs +2.4% on placebo (p<0.0001).
In patients aged 12+ (n=98), setmelanotide group showed 2.5-point reduction in weekly average most hunger score vs 1.3-point for placebo (p=0.0015).
sNDA under FDA review with PDUFA goal date of March 20, 2026; company submits final data package on March 2, 2026.
EMA reviewing Type II variation; CHMP opinion expected Q2 2026, potential EU marketing auth in H2 2026.

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