Denali Receives Formal Letter Regarding FDA Hold On Alzheimer's Potential Program

As previously announced, Denali Therapeutics Inc DNLI was informed via e-mail communication from the FDA that DNL919 TREM Investigational New Drug (IND) application was placed on clinical hold. 

• Denali has now received a formal clinical hold letter and is moving forward to address the FDA's observations related to the preclinical toxicology assessment.
• The Company will also provide the information requested to initiate clinical studies, including proposed changes to the clinical trial protocol, the informed consent form, and the investigator brochure. 
• Related: FDA Places Clinical Hold On Denali's Alzheimer's Potential Program.
• Denali intends to update once a clear path forward has been established.
• Price Action: DNLI shares are down 3.99% at $33.46 during the premarket session on Monday's last check.