Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)
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 ...
DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation
Denali obtains Breakthrough Therapy Designation for its experimental candidate, tividenofusp alfa (DNL310), for the treatment of pateints with Hunter syndrome.
Denali Therapeutics announces U.S. FDA BTD granted for tividenofusp
Denali Therapeutics (DNLI) announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for ...
Denali: Despite ALS Primary Endpoint Failure, Possible Path Forward Remains
Denali Therapeutics Inc.'s stock remains stable despite trial setback in ALS. BLA filing for MPS II treatment on track. Click ...
Investing4d
Denali Therapeutics stock target cut, keeps buy rating on trial results
Despite these results, the analyst believes that Denali's core value lies in its Transport Vesicle (TV) platform and the promising prospects of Tividenofusp alfa, which is expected to be submitted ...
Investing3d
Denali Therapeutics stock target cut, keeps buy rating on trial results
Despite these results, the analyst believes that Denali's core value lies in its Transport Vesicle (TV) platform and the promising prospects of Tividenofusp alfa, which is expected to be submitted for ...
Investing4d
Baird starts Denali Therapeutics stock with Outperform rating
tividenofusp alfa (DNL310). According to InvestingPro data, analyst targets for DNLI range from $24 to $90, with the stock currently trading at $19.82. Denali's DNL310, an enzyme replacement ...
Investing3d
Baird starts Denali Therapeutics stock with Outperform rating
The optimism surrounding the biotechnology company stems from its potential to become a commercial entity by late 2025 or early 2026, following an anticipated accelerated approval from the FDA for its ...