Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)
Denali Therapeutics Inc. (DNLI)
Last denali therapeutics inc. earnings: 8/6 04:30 pm
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Source: GlobeNewswire
SOUTH SAN FRANCISCO, Calif., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tividenofusp alfa (DNL310) for the treatment of individuals with Hunter syndrome (MPS II). This designation is in addition to Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation, all previously granted by the FDA for tividenofusp alfa in Hunter syndrome. Denali expects to submit a Biologics License Application (BLA) for tividenofusp alfa in early 2025 for regulatory review under the accelerated approval pathway. “FDA Breakthrough Therapy Designation is another significant achievement in the development of tividenofusp alfa, our first Enzyme TransportVehicle™ program, uniquely designed to optimize enzyme delivery to both brain and body, addressing the full spectrum of Hunter syndrome, a progressive and devastating disease,” said Caro
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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