Record mula sa primary source
Decision-gradeNaitakda ang petsa ng PDUFA
Rhythm nagtakda ng Marso 20, 2026 PDUFA para sa setmelanotide sNDA sa acquired HO
Itinatag ng dokumento ang Marso 20, 2026 PDUFA goal date para sa supplemental NDA na naghahanap ng pag-apruba ng setmelanotide sa acquired hypothalamic obesity. Ito ang susunod na regulatory decision point para sa pagpapalawak ng label ng gamot lampas sa kasalukuyang indications nito. Kinumpirma rin ng kumpanya ang dalawang Phase 3 topline readouts (Japanese HO cohort at EMANATE trial) na inaasahan sa Q1 2026.
Mahahalagang fact
- Na-file
- Ene 9, 2026, 02:06 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 exhibit991rytmq42025prel.htm EX-99.1 exhibit991rytmq42025prel EXHIBIT 99.1 Rhythm Pharmaceuticals Announces Preliminary, Unaudited Fourth Quarter and Full Year 2025 Net Product Revenues and Upcoming Milestones -- Q4 2025 preliminary net product revenues from global sales of IMCIVREE® (setmelanotide) of approximately $57 million for the fourth quarter of 2025, an 11% increase over Q3 2025 -- -- FY 2025 preliminary net product revenue of approximately $194 million, approximately 50% increase from FY2024 -- -- March 20, 2026 PDUFA goal date for sNDA for setmelanotide in acquired hypothalamic obesity -- -- On track to report topline data from 12-patient Japanese cohort of setmelanotide Phase 3 trial in acquired hypothalamic obesity in first quarter of 2026 -- -- On track to report
Higit pa tungkol sa asset na ito
Decision-grade
May 5, 2026
11:48 AM
RYTMRhythmDecision-grade
Mar 16, 2026
08:30 PM
RYTMRhythmDecision-grade
Mar 2, 2026
11:01 AM
RYTMRhythmDecision-grade
Peb 26, 2026
12:30 PM
RYTMRhythmDecision-grade
Nob 7, 2025
01:09 PM
RYTMRhythmDecision-grade
Nob 4, 2025
12:05 PM
RYTMRhythm