DNLI

Denali Therapeutics Inc.

FDA PDUFA Target Action Date

Sunday, April 5, 2026

51 days ago

pending

Drug Information

Drug Name: Filed (CT.gov)
Application Type: Priority Review

Filing Details

Company: Denali Therapeutics Inc. →
Stock Ticker: DNLI
SEC CIK: 0001714899
Source: SEC 8-K Filing →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

Explore Denali Therapeutics Inc.

View Denali Therapeutics Inc.'s full pipeline, approved drugs, and clinical trials.

View Pipeline → FDA Calendar →

Data sourced from SEC EDGAR filings. Last updated: 2025-12-04. Report an issue