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).
Denali announces encouraging additional longer-term data from the phase I/II Hunter Syndrome study of its investigational therapy, tividenofusp alfa.
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.
Denali Therapeutics Inc DNLI CEO Ryan Watts presented at the J.P. Morgan Healthcare Conference.
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.
Denali obtains Breakthrough Therapy Designation for its experimental candidate, tividenofusp alfa (DNL310), for the treatment of pateints with Hunter syndrome.
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.
Denali Therapeutics said on Monday its experimental drug failed to meet the main goal of a mid-to-late stage trial in patients with amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease.
William Blair has initiated coverage on Denali Therapeutics Inc DNLI, a company focused on developing drugs for neurodegenerative diseases.
Denali Therapeutics (DNLI) reported earnings 30 days ago. What's next for the stock?
DNLI begins dosing in the phase IIa study on BIIB122 in approximately 50 participants with Parkinson's disease and LRRK2 pathogenic mutations confirmed by genetic testing.
Denali Therapeutics' unique blood-brain barrier technology and strategic partnerships offer a significant edge in the challenging neurodegenerative disease landscape. The company's strong cash position and disciplined financial strategy support its ambitious R&D and commercialization efforts without immediate need for additional funding. Denali's pipeline targets critical neurodegenerative pathways, with promising candidates for lysosomal storage disorders, Parkinson's disease, and neuroinflammation.