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

Sinabi ng kumpanya na ang NDA para sa pitolisant GR ay isusumite sa Q2 2026 at may inaasahang PDUFA date sa Q1 2027. Tinutukoy nito ang susunod na pormal na regulatory milestone para sa gastro-resistant formulation na idinisenyo upang pahabain ang pitolisant franchise hanggang 2040s.

Mahahalagang fact

Na-file: Peb 24, 2026, 01:10 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-20260224xex99d1.htm EX-99.1 ‌ Exhibit 99.1 HARMONY BIOSCIENCES REPORTS STRONG 2025 FINANCIAL RESULTS AND REITERATES 2026 NET REVENUE GUIDANCE OF OVER $1 BILLION WAKIX 2025 Net Revenue of $868.5 Million; 2026 WAKIX Net Revenue Guidance of $1.0 – $1.04 Billion on Track for Blockbuster Status in Narcolepsy Recently Completed Settlements with 3 Additional Generic Filers Toward Goal of Securing WAKIX Franchise Pitolisant GR NDA Submission on Track for Q2 2026; Extends the Pitolisant Franchise into the 2040s Exploring New Opportunities to Broaden the Pitolisant Franchise Beyond Orphan/Rare into Larger CNS Indications Potential Best-In-Class Orexin-2 Agonist (BP1.15205) Phase 1 Trial Ongoing; Clinical Data Expected in Mid-2026 Conference Call and Webcast Today at 8:

SEC 8-K