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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER