Currently available therapies for Hunter syndrome don’t cross the blood-brain barrier to address cognitive symptoms of the inherited enzyme deficiency. Denali Therapeutics' technology gets its drug across the protective membrane, and the biotech plans to seek accelerated FDA approval in this rare disease.
Sanofi, which is leading development of the Denali Therapeutics-partnered molecule, disclosed little about the clinical trial results in ALS. But this Phase 2 failure follows the 2020 clinical trial pause of a different partnered molecule that addresses the same target.
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The FDA placed a clinical hold on Denali Therapeutics’ application to begin Phase 1 testing of an antibody drug for Alzheimer’s disease. The Denali drug uses the biotech’s proprietary technology to deliver therapeutic cargo across the protective blood-brain barrier.
The capital raise is the culmination of a year that was punctuated with two of its portfolio companies filing initial public offerings and the hire of J.P. Morgan veteran Stephen Berenson.
Get the latest: FDA outlines genetic testing standards, everyone writes about Denali and California moves on a batter vaccination bill.