Denali Therapeutics Announces FDA Clinical Hold on DNL919 Investigational New Drug (IND) Application

SOUTH SAN FRANCISCO, CA, USA I January 13, 2022 I Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced that after the close of business (Eastern Time) on Wednesday, January 12, 2022, the company was informed via e-mail communication from the U.S. Food and Drug Administration (FDA) that the DNL919 (ATV:TREM2) Investigational New Drug (IND) application has been placed on clinical hold. The FDA indicated they will provide an official clinical hold letter to Denali in approximately 30 days. Denali plans to provide additional updates pending discussion with the FDA.

About Denali Therapeutics
Denali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the BBB and guiding development through biomarkers that demonstrate target and pathway engagement. Denali is based in South San Francisco. For additional information, please visit www.denalitherapeutics.com.

SOURCE: Denali Therapeutics

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