By Colin Kellaher

Shares of Denali Therapeutics Inc. fell sharply Thursday after the biopharmaceutical company's plans to study its DNL919 drug candidate in Alzheimer's disease hit a snag with the U.S. Food and Drug Administration.

The San Francisco company said the FDA has placed the company's investigational new drug application for DNL919 on clinical hold.

Denali said it received an e-mail notification from the FDA after the close of business Wednesday, and that the agency said it would provide an official letter in about 30 days.

Denali earlier this week had said that pending FDA acceptance of the application, it planned to initiate first-in-human clinical trials of DNL919 in Alzheimer's in the first half of the year, with human safety and biomarker data available in the second half.

The company also had said that Takeda Pharmaceutical Co., its collaboration partner since early 2018, had exercised its option to co-develop and co-commercialize DNL919 for the treatment of the memory-loss disease.

According to the FDA's website, subjects can't be given an investigational drug when a proposed study is placed on clinical hold. The agency lists several potential reasons for putting an IND on hold, including the possibility that human subjects "would be exposed to an unreasonable and significant risk of illness or injury," or that the application doesn't contain enough information to assess the risks to subjects of the proposed studies.

Denali said it plans to provide additional updates on the DNL919 application, pending discussions with the FDA.

Shares of Denali were recently changing hands at $33.55, down 13%, after hitting a 52-week low of $30.25 early in the session.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

01-13-22 1016ET