Record mula sa primary source
Decision-gradeNaitakda ang petsa ng PDUFA
Itinakda ng Rhythm ang PDUFA sa Dis. 20, 2025 para sa setmelanotide sNDA sa acquired hypothalamic obesity (HO)
Tinanggap ng FDA ang sNDA para sa setmelanotide sa acquired hypothalamic obesity at binigyan ito ng Priority Review. Itinalaga ang PDUFA goal date na December 20, 2025, na nagtatatag ng malapit na punto ng desisyon sa regulasyon para sa bagong indikasyon.
Mahahalagang fact
- Na-file
- Nob 4, 2025, 12:05 PM
- 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 · Positibo
Sipi mula sa source
EX-99.1 2 rytm-20251104xex99d1.htm EX-99.1 Exhibit 99.1 Rhythm Pharmaceuticals Reports Third Quarter 2025 Financial Results and Business Update -- Third quarter 2025 net product revenue from global sales of IMCIVREE ® (setmelanotide) of $51.3 million -- -- December 20, 2025 PDUFA goal date set for sNDA for setmelanotide in acquired hypothalamic obesity -- -- Company is on track to report preliminary results from setmelanotide Phase 2 trial in Prader-Willi syndrome in fourth quarter of 2025 -- -- German observational study showed setmelanotide therapy was associated with improvement in measures of MASLD and kidney function in BBS patients -- -- Management to host conference call today at 8:00 a.m. ET -- BOSTON, November 4, 2025 – Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM)
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