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

 As previously announced, Denali Therapeutics Inc 

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 (Get Free Alerts for 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. 
• Denali intends to update once a clear path forward has been established.

https://www.benzinga.com/general/biotech/22/02/25597158/denali-receives-formal-letter-regarding-fda-hold-on-alzheimers-potential-program