Denali: FDA extends PDUFA date for tividenofusp alfa BLA to April 5, 2026

The FDA extended the PDUFA action date for Denali's BLA seeking accelerated approval of tividenofusp alfa in MPS II from January 5, 2026 to April 5, 2026. The extension was triggered by the agency's classification of updated clinical pharmacology data as a Major Amendment to the application.

Key facts

Filed: Oct 14, 2025, 12:10 PM
Event: PDUFA date extended
Direction: Negative
Company: DNLIDenali Therapeutics
Asset: tividenofusp alfa
Source: SEC 8-K
Confidence: Sourced
Calendar: FDA decision (PDUFA) · Apr 5, 2026 · Approved

Source excerpt

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) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol (s) Name of each exchange on which registered C

SEC 8-K