Denali CEO Ryan Watts

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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