Harmony Biosciences: Tinanggap ang Pitolisant GR NDA; PDUFA Abril 1, 2027

Tinanggap ng FDA ang NDA para sa pitolisant GR tablets noong Hulyo 2026. Nagtalaga ang ahensya ng target na petsa ng PDUFA na Abril 1, 2027, na nagtatakda ng regulatory timeline para sa gastro-resistant formulation na ito na inilaan upang mabawasan ang mga side effect sa GI at payagan ang therapeutic dosing nang walang titration.

Mahahalagang fact

Na-file: Ago 4, 2026, 12:05 PM
Kaganapan: Pinalawig ang petsa ng PDUFA
Direksyon: Negatibo
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-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