Denali: itinakda ng FDA ang PDUFA na Abril 5, 2026 para sa tividenofusp alfa BLA

Nakasaad sa dokumento na ang FDA ay nagtalaga ng PDUFA target action date na April 5, 2026 para sa BLA ng tividenofusp alfa sa ilalim ng accelerated approval pathway. Tinutukoy nito ang regulatory decision timeline para sa unang potensyal na commercial launch ng Denali TV-enabled therapy.

Mahahalagang fact

Na-file: Ene 6, 2026, 01:02 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 ex9912026outlookpressrelea.htm EX-99.1 Document Exhibit 99.1 Denali Therapeutics Announces Key Anticipated Milestones and Priorities for 2026 Including Commercial Launch of Tividenofusp Alfa for Hunter Syndrome • Preparing for FDA approval and commercial launch of tividenofusp alfa, Denali’s TransportVehicle™ (TV)-enabled investigational therapy for Hunter syndrome • Expecting multiple clinical data readouts from pipeline programs including for Sanfilippo syndrome Type A (ETV:SGSH), granulin-related frontotemporal dementia (PTV:PGRN) and Parkinson’s disease (LRRK2 inhibitor) • Planning for initiation of first-in-human clinical studies with TV-enabled therapeutics for Alzheimer’s disease (OTV:MAPT, ATV:Abeta) and Pompe disease (ETV:GAA) • Continuing to strengthen leadership in t

SEC 8-K