Rhythm: itinakda ang PDUFA sa Marso 20, 2026 para sa sNDA ng setmelanotide sa acquired hypothalamic obesity (HO)

FDA accepted the sNDA for setmelanotide in acquired hypothalamic obesity and assigned a PDUFA goal date of March 20, 2026. Additional 52-week data from the TRANSCEND trial (N=142) showed an 18.8% placebo-adjusted BMI reduction, reinforcing the pivotal dataset. The company will submit the final data package on March 2, 2026.

Mahahalagang fact

Na-file: Mar 2, 2026, 11:01 AM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Positibo
Kumpanya: RYTMRhythm
Asset: setmelanotide
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Mar 20, 2026 · Inaprubahan
Katamtamang pagbabago ng BMI (placebo): +2.4%
Pagbawas ng iskor ng gutom (placebo): 1.3 puntos
Pagbawas ng BMI na naayos batay sa placebo: -18.8%
Katamtamang pagbawas ng BMI (setmelanotide): -16.4%
Pagbawas ng iskor ng gutom (setmelanotide): 2.5 puntos

Sipi mula sa source

EX-99.1 2 tm267699d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Rhythm Pharmaceuticals Announces Additional Positive Data from Phase 3 TRANSCEND trial of Setmelanotide in Patients with Acquired Hypothalamic Obesity -- - 18.8% placebo-adjusted difference in BMI reduction achieved in all patients (N=142) at 52 weeks, including 12 Japanese patients and 10 supplemental patients with acquired hypothalamic obesity -- -- March 20, 2026 PDUFA goal date for sNDA for setmelanotide in acquired hypothalamic obesity -- BOSTON, March 1, 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 additional positive data from its global Phase 3 TRANSCEND trial

SEC 8-K