FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months

FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval

Denali and AbbVie’s ALS Candidates Fail Phase 2/3 Trials, Highlighting Challenges in ALS Research

ALS, Denali Therapeutics, AbbVie, Calico Life Sciences, HEALEY ALS Platform Trial, DNL343, fosigotifator, amyotrophic lateral sclerosis, clinical trials, drug development

Denali Therapeutics’ ALS Drug DNL343 Fails to Meet Primary Efficacy Endpoints in Phase 2/3 HEALEY ALS Platform Trial

Denali Therapeutics, DNL343, ALS (Amyotrophic Lateral Sclerosis), HEALEY ALS Platform Trial, eIF2B agonist, Clinical trial failure, Neurodegenerative diseases