Rhythm's Phase 3 EMANATE trial misses primary endpoints; post hoc signals in POMC/SRC1

RHYTHM PHARMACEUTICALS, INC.

Four substudies failed primary endpoint: placebo-adjusted BMI reductions of 4.3% (POMC/PCSK1), 3.6% (LEPR), 4.0% (SRC1), 1.7% (SH2B1); all p>0.05.
Post hoc LOCF analysis showed significant BMI reductions: POMC/PCSK1 -5.5% (p=0.0010), SRC1 -6.2% (p<0.0001) vs placebo.
Completer analysis: placebo-adjusted BMI -9.7% (POMC/PCSK1, n=41, p=0.0002) and -8.0% (SRC1, n=29, p=0.0158).
Safety profile consistent with prior studies; no new signals. Common AEs: skin hyperpigmentation, injection-site reactions.
Rhythm to evaluate next-gen MC4R agonists bivamelagon and RM-718 for SRC1 and POMC; continuing DAYBREAK exploratory work.

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