1차 출처 기록
결정급PDUFA 날짜 확정
Rhythm, 후천성 시상하부 비만(HO)에 대한 setmelanotide sNDA의 PDUFA 날짜를 2026년 3월 20일로 지정
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.
핵심 사실
출처 발췌
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