Denali Therapeutics (DNLI) announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for tividenofusp alfa for the treatment of individuals with Hunter syndroms. 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.
Stay Ahead of the Market:
- Discover outperforming stocks and invest smarter with Top Smart Score Stocks
- Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on DNLI:
- Denali recent pullback a buying opportunity, says Jefferies
- BofA trims Denali Therapeutics price target to $30, says weakness an opportunity
- Denali Therapeutics price target lowered to $32 from $35 at BTIG
- 3 Best Stocks to Buy Now, 1/7/2025, According to Top Analysts
- Denali Therapeutics price target lowered to $87 from $90 at H.C. Wainwright