DNLI Begins Rolling BLA Submission for Hunter Syndrome Drug, Stock Up [Yahoo! Finance]
Denali Therapeutics Inc. (DNLI)
Last denali therapeutics inc. earnings: 8/6 04:30 pm
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Source: Yahoo! Finance
license application (BLA) for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome (MPS II). The same has also been received by the Center for Drug Evaluation and Research (CDER) of the FDA. DNLI reported ongoing collaborative and productive engagement with CDER, aligning with the same on the content of the BLA data package, including the use of CSF HS as a surrogate endpoint for accelerated approval and the path to full approval. Denali expects to complete its BLA submission by mid-May 2025 and is preparing for a potential U.S. commercial launch in late 2025 or early 2026. Tividenofusp alfa, an Enzyme Transport Vehicle-enabled iduronate-2-sulfatase (IDS) replacement therapy, enjoys the FDA's Fast Track and Breakthrough Therapy designations in the United States for MPS II. In the EU, the candidate enjoys the Priority Medicines designation for the same indication. Year to date, shares of DNLI have lost 32.6% against the industry's 1.2% growth. Image So
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DNLI
News
- Denali Therapeutics (NASDAQ:DNLI) had its price target lowered by analysts at Wedbush from $31.00 to $30.00. They now have an "outperform" rating on the stock.MarketBeat
- Denali Therapeutics Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants [Yahoo! Finance]Yahoo! Finance
- Denali Therapeutics Announces Pricing of Public Offering of Common Stock and Pre-Funded WarrantsGlobeNewswire
- Denali Therapeutics Announces Proposed Offering of Common Stock and Pre-Funded Warrants [Yahoo! Finance]Yahoo! Finance
- Denali Therapeutics Announces Proposed Offering of Common Stock and Pre-Funded WarrantsGlobeNewswire
DNLI
Earnings
- 11/6/25 - Beat
DNLI
Sec Filings
- 12/15/25 - Form 4
- 12/10/25 - Form 8-K
- 12/10/25 - Form 424B5
- DNLI's page on the SEC website