As previously announced, Denali Therapeutics Inc (NASDAQ:DNLI) was informed via e-mail communication from the FDA that DNL919 (ATV:TREM2) 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.
