Denali: FDA nagpalawig ng PDUFA para sa tividenofusp alfa hanggang Abril 5, 2026

Inuri ng FDA ang na-update na klinikal na pagsusumite ng pharmacology ng Denali bilang Major Amendment, na nagpalawig ng target na petsa ng aksyon ng PDUFA para sa pinabilis na pag-apruba ng tividenofusp alfa sa MPS II ng tatlong buwan mula Enero 5, 2026 hanggang Abril 5, 2026. Walang bagong data ng bisa, kaligtasan o biomarker na hiniling; ang pagpapalawig ay pamamaraan lamang. Sinabi ng Denali na ang susog ay hindi nagbabago sa klinikal na pharmacology o mga konklusyon ng benepisyo-panganib ng BLA.

Mahahalagang fact

Na-file: Nob 6, 2025, 09:03 PM
Kaganapan: Pinalawig ang petsa ng PDUFA
Direksyon: Negatibo
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 ex991pressreleaseq32025.htm EX-99.1 Document Exhibit 99.1 Denali Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights • Tividenofusp alfa BLA review process for accelerated approval for MPS II continues with productive engagement with the FDA; commercial launch preparations on track • DNL126 Phase 1/2 study enrollment completed, supporting an accelerated approval path in MPS IIIA • Two new regulatory applications submitted to initiate clinical studies with DNL628 (OTV:MAPT) for Alzheimer’s disease and DNL952 (ETV:GAA) for Pompe disease • Tim Van Hauwermeiren, CEO of argenx, to join Denali's Board of Directors • Carole Ho, M.D., Chief Medical Officer, departing company; Peter Chin, M.D., assuming role of Acting CMO and Head of Development • Denali t

SEC 8-K