Harmony Biosciences:Pitolisant GR 的 NDA 申請預計於 2026 年第二季提交,PDUFA 訂於 2027 年第一季

該公司宣布，Pitolisant GR（gastro-resistant pitolisant）的NDA計劃於Q2 2026提交。預計PDUFA日期為Q1 2027，將pitolisant特許經營權延伸至2040年代，其配方旨在減少GI副作用，並允許無需滴定的治療劑量。

關鍵事實

申報時間: 2026年5月7日下午01:24
事件: PDUFA 日期確定
方向: 中性
公司: HRMYHarmony Biosciences
資產: pitolisant GR
來源: SEC 8-K
可信度: 有出處
行事曆: FDA 審查決定 (PDUFA) · 2027年4月1日

來源摘錄

EX-99.1 2 hrmy-20260507xex99d1.htm EX-99.1 Exhibit 99.1 HARMONY BIOSCIENCES REPORTS Q1 FINANCIAL RESULTS AND CONFIRMS 2026 NET REVENUE GUIDANCE OF OVER $1 BILLION; REINFORCES 2026 STRATEGIC PRIORITIES WAKIX® Net Revenue Grew 17% to $215.4 Million for First Quarter 2026; On Track for Full Year 2026 Net Revenues over $1 Billion Continue to Vigorously Protect WAKIX IP into 2030; Filed Suit Against AET Pharma/Sandoz Regarding Infringement of Amorphous Pitolisant Patent Lifecycle Management Advancing with Pitolisant GR on Track for NDA Filing 2Q26, Pitolisant HD Phase 3 Data in 2027, and Recently Acquired Novel Amorphous Form of Pitolisant to Pursue Broader CNS Indications Potential Best-in-Class Orexin-2 Agonist with BP-205; Phase 1 Clinical PK Data On Track for Mid-2026 Renewed Fo

SEC 8-K