Denali Therapeutics Announces FDA Review Extension of BLA for Tividenofusp Alfa for the Treatment of MPS II (Hunter Syndrome)
Denali Therapeutics Inc. (DNLI)
Last denali therapeutics inc. earnings: 8/6 04:30 pm
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Source: GlobeNewswire
SOUTH SAN FRANCISCO, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that the U.S. Food and Drug Administration (FDA) has extended its review timeline of the Biologics License Application (BLA) seeking accelerated approval of tividenofusp alfa for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome. The Prescription Drug User Fee Act (PDUFA) target date has been extended from January 5, 2026, to April 5, 2026. The extension follows Denali’s submission of updated clinical pharmacology information in response to an information request from the FDA as part of the standard review process and is not related to efficacy, safety or biomarkers. The FDA classified the submission as a Major Amendment (MA) to the BLA, which, per FDA regulations, extends the review by three months. No additional data were requested by the FDA in the MA letter. Denali believes that the updated information submitted in the amend
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News
- Denali Therapeutics (NASDAQ:DNLI) had its "buy" rating reaffirmed by analysts at BTIG Research. They now have a $32.00 price target on the stock.MarketBeat
- Denali Therapeutics (NASDAQ:DNLI) had its "outperform" rating reaffirmed by analysts at Wedbush.MarketBeat
- Denali Therapeutics and Royalty Pharma Announce $275 Million Royalty Funding AgreementGlobeNewswire
- Denali Therapeutics (NASDAQ:DNLI) was given a new $37.00 price target on by analysts at Stifel Nicolaus.MarketBeat
- Denali Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights [Yahoo! Finance]Yahoo! Finance
DNLI
Earnings
- 11/6/25 - Beat
DNLI
Sec Filings
- 12/4/25 - Form 144
- 12/4/25 - Form 8-K
- 12/4/25 - Form 8-K
- DNLI's page on the SEC website