Denali: tividenofusp alfa PDUFA itinakda sa Abril 5, 2026

Ang BLA para sa tividenofusp alfa ay may PDUFA target action date na Abril 5, 2026 sa ilalim ng accelerated approval pathway. Itinatag ng Denali ang commercial launch readiness bago ang petsang ito. Ang kasalukuyang Phase 2/3 COMPASS study ay inaasahang magbibigay ng confirmatory evidence para sa global regulatory submissions.

Mahahalagang fact

Na-file: Peb 26, 2026, 09:07 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: DNLIDenali Therapeutics
Asset: tividenofusp alfa
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Abr 5, 2026 · Inaprubahan

Sipi mula sa source

EX-99.1 2 ex991pressreleaseq42025.htm EX-99.1 Document Exhibit 99.1 Denali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights • Tividenofusp alfa (DNL310; ETV:IDS) launch readiness established ahead of April 5, 2026 Prescription Drug User Fee Act (PDUFA) target action date for Hunter syndrome • DNL126 (ETV:SGSH) Phase 1/2 preliminary data presented at 2026 WORLD Symposium TM , supporting plans to pursue an accelerated approval path in Sanfilippo syndrome type A • Start-up activities underway for DNL628 (OTV:MAPT) Phase 1b study for Alzheimer's disease and DNL952 (ETV:GAA) Phase 1 study for late-onset Pompe disease • TransportVehicle TM platform and clinical pipeline progressing across lysosomal storage disorders and neurodegenerative disease

SEC 8-K