Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)
Denali expects to submit a Biologics License Application for tividenofusp alfa in early 2025 for regulatory review under the accelerated approval pathwaySOUTH SAN FRANCISCO, Calif., Jan. 08, 2025 ...
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: 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 ...
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 ...
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Denali Therapeutics Neurodegenerative Disease Platform Sparks Analyst Optimistic
Denali plans to submit a biologics license application for tividenofusp alfa in early 2025. The analyst highlights that Denali is developing a specialized transport vehicle (TV) platform to ...
Denali Therapeutics initiated with an Outperform at Baird
Baird last night initiated coverage of Denali Therapeutics (DNLI) with an Outperform rating and $31 price target The firm believes Denali is ...
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 ...
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 ...
AOL7d
Denali Therapeutics Neurodegenerative Disease Platform Sparks Analyst Optimistic
The company’s lead program Tividenofusp alfa, an enzyme-replacement therapy for Hunter syndrome, shows promise as a best-in-class treatment, the analyst highlights. William Blair has initiated ...
Yahoo Finance7d
Denali Therapeutics Neurodegenerative Disease Platform Sparks Analyst Optimistic
The company’s lead program Tividenofusp alfa, an enzyme-replacement therapy for Hunter syndrome, shows promise as a best-in-class treatment, the analyst highlights. William Blair has initiated with an ...
Investing3d
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 ...