Record mula sa primary source
Decision-gradeNaitakda ang petsa ng PDUFA
Rhythm: itinakda ang PDUFA sa Marso 20, 2026 para sa setmelanotide sNDA sa acquired HO
FDA assigned a March 20, 2026 PDUFA goal date for the supplemental NDA seeking approval of setmelanotide in acquired hypothalamic obesity. The company stated it is prepared to launch IMCIVREE in the U.S. for this indication pending FDA approval.
Mahahalagang fact
- Na-file
- Peb 26, 2026, 12:30 PM
- Kaganapan
- Naitakda ang petsa ng PDUFA
- Direksyon
- Neutral
- 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 rytm4q2025earningspr_v1.htm EX-99.1 Document Rhythm Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Business Update -- Fourth quarter 2025 net product revenue from global sales of IMCIVREE ® (setmelanotide) of $57.3 million -- -- March 20, 2026 PDUFA goal date for sNDA for setmelanotide in acquired hypothalamic obesity (HO) -- -- Phase 2 open-label extension data showed bivamelagon achieved persistent BMI reductions at six and nine months; Completed positive end-of-Phase-2 meeting with FDA -- -- On track to report topline data from 12-patient Japanese cohort of setmelanotide Phase 3 trial in acquired HO in March 2026 -- -- On track to report topline data from Phase 3 EMANATE trial evaluating setmelanotide in rare genetically caused melanocor
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