Denali Therapeutics Inc. (DNLI)
DNLI's BLA for Hunter Syndrome Drug Gets FDA's Priority Review
Denali's lead drug for Hunter syndrome wins FDA Priority Review, marking a key step toward commercial-stage status.
Why Is Denali Therapeutics (DNLI) Up 0.7% Since Last Earnings Report?
Denali Therapeutics (DNLI) reported earnings 30 days ago. What's next for the stock?
Denali Q1 Loss Wider Than Expected, Hunter Syndrome Drug in Focus
DNLI reports a wider-than-expected loss for the first quarter of 2025. Denali submits a BLA for tividenofusp alfa under the FDA?
DNLI Begins Rolling BLA Submission for Hunter Syndrome Drug, Stock Up
Denali stock up as it begins rolling BLA submission with the FDA for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome.
Why You Shouldn't Bet Against Denali (DNLI) Stock
Denali (DNLI) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.
Denali Q4 Earnings Beat Estimates, Hunter Syndrome Drug in Focus
DNLI reports a narrower-than-expected loss for the fourth quarter of 2024. Denali remains on track to submit a BLA for tividenofusp alfa for the treatment of MPS II (Hunter syndrome).
DNLI Reports Upbeat Longer-Term Data From Hunter Syndrome Study
Denali announces encouraging additional longer-term data from the phase I/II Hunter Syndrome study of its investigational therapy, tividenofusp alfa.
Denali Gains 26.6% in a Year: How Should You Play the Stock?
DNLI has had a good run in the past year on positive pipeline updates. A potential approval of its Hunter Syndrome drug should be a boost.
Why Is Denali Therapeutics Stock Trading Higher On Wednesday?
Denali Therapeutics Inc DNLI CEO Ryan Watts presented at the J.P. Morgan Healthcare Conference.
Denali: Despite ALS Primary Endpoint Failure, Possible Path Forward Remains
Denali Therapeutics Inc.'s DNL343 failed to meet the primary endpoint in the phase 2/3 HEALY ALS trial, but potential biomarker analyses in 2025 may offer a path forward. Despite the trial setback in ALS, Denali's stock remains stable due to continued pre-specified analyses expected in late 2025. BLA filing of tividenofusp alfa for the treatment of patients with MPS II remains on track under the Accelerated Approval Pathway Program in early 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's ALS Study Fails to Meet Primary and Secondary Endpoints
DNLI's DNL343 fails to achieve the primary and secondary endpoints, as observed from an analysis of Regimen G of the phase II/III HEALEY ALS platform trial.
