Denali offers more clues on clinical hold, turning over FDA worries on preclinical tox for Alzheimer's drug
Denali hit a major speed bump last month with the FDA hitting the pause button on its lead Alzheimer’s drug. Now, the biotech has offered more clues on what exactly held the agency up.
In an SEC filing Monday, Denali released more details on an FDA clinical hold on Alzheimer’s drug DNL919 leveled last month, revealing concerns around a preclinical toxicology assessment and showing intent to switch up plans for a first-in-human study.
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