Record mula sa primary source
Decision-gradePinalawig ang petsa ng PDUFA
Rhythm Pharmaceuticals: pinahaba ng FDA ang PDUFA ng sNDA ng IMCIVREE hanggang Marso 20, 2026
FDA extended the PDUFA goal date for the setmelanotide sNDA in acquired hypothalamic obesity from December 20, 2025 to March 20, 2026 after classifying a major amendment. The amendment consists only of additional sensitivity analyses of Phase 3 efficacy data; no new safety or manufacturing data were requested.
Mahahalagang fact
- Na-file
- Nob 7, 2025, 01:09 PM
- Kaganapan
- Pinalawig 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 rytm-20251106xex99d1.htm EX-99.1 Exhibit 99.1 Rhythm Pharmaceuticals Announces FDA Extension of Review Period for IMCIVREE ® (setmelanotide) for Patients with Acquired Hypothalamic Obesity -- FDA sets updated PDUFA goal date of March 20, 2026 – -- Company to hold conference today at 8:00 a.m. -- BOSTON, November 7 , 2025 – 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 that the U.S. Food and Drug Administration (FDA) has extended by three months the review period for the supplemental New Drug Application (sNDA) for IMCIVREE ® (setmelanotide) for the treatment of acquired hypothalamic obesity. On Nov. 6, the FDA notified the C
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