Denali: Pinalawig ng FDA ang PDUFA date para sa tividenofusp alfa BLA hanggang Abril 5, 2026

Pinalawig ng FDA ang PDUFA action date para sa BLA ng Denali na humihiling ng accelerated approval ng tividenofusp alfa sa MPS II mula Enero 5, 2026 hanggang Abril 5, 2026. Ang pagpapalawig ay dulot ng pag-uuri ng ahensya sa updated clinical pharmacology data bilang Major Amendment sa aplikasyon.

Mahahalagang fact

Na-file: Okt 14, 2025, 12:10 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

dnli-20251013 0001714899 FALSE 0001714899 2025-10-13 2025-10-13 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 13, 2025 Denali Therapeutics Inc. (Exact name of registrant as specified in its charter) Delaware 001-38311 46-3872213 (State or other jurisdiction of (Commission (I.R.S. Employer incorporation) File Number) Identification No.) 161 Oyster Point Blvd. South San Francisco , California 94080 (Address of principal executive offices, including zip code) ( 650 ) 866-8547 (Registrant’s telephone number, including area code) Not Applicable (Former name or former address, if changed since last reports) Che

SEC 8-K