After some high-profile crashes, the one-time biotech darling is inching toward success with its Hunter syndrome treatment, which today began a rolling BLA for accelerated approval.

Denali Therapeutics’ amyotrophic lateral sclerosis (ALS) drug has racked up another clinical miss this year, leaving the company to mull the asset’s future.

After winning a breakthrough therapy designation for its Hunter syndrome enzyme replacement therapy, Denali Therapeutics is climbing closer to its goal of accelerated approval by unveiling data showing the drug met its primary safety endpoints and reduced key biomarkers of the disease.

Tenvie Therapeutics has unveiled with $200 million and the goal of transforming the neurological treatment landscape, nabbing several programs—and an executive—from Denali Therapeutics.

Denali’s medicine and a similar one from Calico Life Sciences and AbbVie were not much different than a placebo, results that reinforce the difficulty of ALS drug research.

Denali Therapeutics (NASDAQ: DNLI) announced topline results from Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating eIF2B agonist DNL343 for amyotrophic lateral sclerosis (ALS) treatment. The study did not meet its primary endpoint of slowing disease progression compared to placebo, measured by ALS Functional Rating Scale-Revised (ALSFRS-R) and survival through week 24.

Some existing investors are pumping $500 million into Denali Therapeutics to help support ongoing research and development activities, including its blood-brain barrier crossing therapeutics. The biotech announced the sale of more of its shares through a private investment in public equity financing Tuesday. 

 Drug developer Denali Therapeutics (DNLI.O) said on Friday its and partner Sanofi's (SASY.PA) experimental drug for a fatal neurodegenerative disease failed to slow decline of motor function in a mid-stage study.