Harmony Biosciences: NDA filing ng Pitolisant GR sa Q2 2026, PDUFA sa Q1 2027

Inihayag ng kumpanya na ang NDA para sa Pitolisant GR (gastro-resistant pitolisant) ay nasa tamang iskedyul para sa pagsusumite sa Q2 2026. Ang inaasahang petsa ng PDUFA ay Q1 2027, na nagpapahaba sa pitolisant franchise hanggang 2040s gamit ang isang formulation na idinisenyo upang mabawasan ang mga side effect sa GI at payagan ang therapeutic dosing nang walang titration.

Mahahalagang fact

Na-file: May 7, 2026, 01:24 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: HRMYHarmony Biosciences
Asset: pitolisant GR
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Abr 1, 2027

Sipi mula sa source

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