Harmony Biosciences: Pitolisant GR NDA 접수, PDUFA 2027년 4월 1일

FDA accepted the NDA for pitolisant GR tablets in July 2026. The agency assigned a target PDUFA date of April 1, 2027, setting the regulatory timeline for this gastro-resistant formulation intended to reduce GI side effects and allow therapeutic dosing without titration.

핵심 사실

제출: 2026년 8월 4일 PM 12:05
이벤트: PDUFA 날짜 연장
방향: 부정적
기업: HRMY하모니 바이오사이언스
자산: pitolisant GR
출처: SEC 8-K
신뢰도: 출처 확인
캘린더: FDA 심사 결정 (PDUFA) · 2027년 4월 1일

출처 발췌

EX-99.1 2 hrmy-20260804xex99d1.htm EX-99.1 ‌ Exhibit 99.1 Harmony Biosciences Announces Record Q2 2026 Re venue and Shares Initial Clinical Data for Its Orexin-2 Agonist BP-205 Reinforcing Potential Best-in-Class Profile WAKIX® Net Revenue Grew 30% Year over Year to $261.3 Million for Second Quarter 2026; Estimated Average Patients Increased 450 to 8,950; Reiterates 2026 WAKIX Net Revenue Guidance of $1. 0 Billion to $1.04 Billion Phase 1 SAD Data for BP-205 Demonstrate Favorable PK and Safety/Tolerability Profiles ; Phase 1 MAD Data Expected in Q4 2026 BP-205 IND Open in US; Initiating Phase 1b Study in Sleep-Deprived Healthy Volunteers in Q3; Data Expected Early 2027 Initiating Phase 2 Trials for BP-205 in Mid-2027 to Evaluate Multiple CNS Indications Pitolisant GR NDA Accepted in July

SEC 8-K