Rhythm Pharmaceuticals: Hindi naabot ng topline results ng Phase 3 EMANATE ang primary endpoint

Ang apat na EMANATE Phase 3 substudies na sumusuri sa setmelanotide sa heterozygous MC4R-pathway obesities ay nabigo na matugunan ang kanilang pre-specified primary endpoints para sa BMI reduction sa 52 weeks. Ipinakita ng post-hoc analyses ang statistically significant BMI reductions sa POMC/PCSK1 at SRC1 (NCOA1) substudies, ngunit ang mga ito ay exploratory at hindi regulatory-grade. Gagamitin ng Rhythm ang data para sa pagpipino ng variant selection at gabay sa next-generation MC4R agonist development.

Mahahalagang fact

Na-file: Mar 16, 2026, 08:30 PM
Kaganapan: Topline na resulta
Direksyon: Negatibo
Kumpanya: RYTMRhythm
Asset: setmelanotide
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Mar 20, 2026 · Positibo
Pagbawas ng BMI sa SH2B1: -1.7% naayos batay sa placebo (p=0.43)
Pagbawas ng BMI sa LEPR Hets: -3.6% naayos batay sa placebo (p=0.94)
Pagbawas ng BMI sa SRC1/NCOA1: -4.0% naayos batay sa placebo (p=0.12)
Pagbawas ng BMI sa POMC/PCSK1 Hets: -4.3% naayos batay sa placebo (p=0.15)
Pagbawas ng BMI sa SRC1/NCOA1 (post-hoc): -6.2% (LS na average; p<0.0001)
Pagbawas ng BMI sa POMC/PCSK1 Hets (post-hoc): -5.5% (LS na average; p=0.0010)

Sipi mula sa source

EX-99.1 2 ex991rytm20260616emanatepr.htm EX-99.1 Document EXHIBIT 99.1 Rhythm Pharmaceuticals Announces Topline Results from Phase 3 EMANATE Trial -- Four substudies did not meet pre-specified primary endpoints -- -- Post hoc analyses show setmelanotide achieved statistically significant BMI reductions in patients with obesity due to a heterozygous variant of the POMC/PCSK1 and SRC1 (NCOA1) genes at 52 weeks – -- Conference call planned for 4:30 p.m. ET today – BOSTON, March 16, 2026 – Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced the topline results from its EMANATE trial. The four substudies of this global, Phase 3 trial evaluating s

SEC 8-K