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Denali Therapeutics (DNLI) FDA Events

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FDA Events for Denali Therapeutics (DNLI)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Denali Therapeutics (DNLI). Over the past two years, Denali Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as BEACON, DNL126, DNL310, DNL343, and tividenofusp. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Denali Therapeutics' Drugs in FDA Review

BEACON - FDA Regulatory Timeline and Events

BEACON is a drug developed by Denali Therapeutics for the following indication: For Parkinson's Disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

DNL126 - FDA Regulatory Timeline and Events

DNL126 is a drug developed by Denali Therapeutics for the following indication: For MPS IIIA (Sanfilippo Syndrome Type A). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

DNL310 - FDA Regulatory Timeline and Events

DNL310 is a drug developed by Denali Therapeutics for the following indication: Gene therapy that reduces the rate of abnormal bleeding in eligible people with hemophilia B by enabling the body to continuously produce factor IX, the deficient protein in hemophilia B. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

DNL343 - FDA Regulatory Timeline and Events

DNL343 is a drug developed by Denali Therapeutics for the following indication: Amyotrophic lateral sclerosis (ALS). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

tividenofusp - FDA Regulatory Timeline and Events

tividenofusp is a drug developed by Denali Therapeutics for the following indication: For the treatment of Hunter syndrome (MPS II). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Denali Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Denali Therapeutics (DNLI) has reported FDA regulatory activity for the following drugs: tividenofusp, DNL343, DNL310, DNL126 and BEACON.

The most recent FDA-related event for Denali Therapeutics occurred on July 7, 2025, involving tividenofusp. The update was categorized as "PDUFA Date," with the company reporting: "Denali Therapeutics Inc. announced that The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of January 5, 2026."

Current therapies from Denali Therapeutics in review with the FDA target conditions such as:

  • For the treatment of Hunter syndrome (MPS II) - tividenofusp
  • Amyotrophic lateral sclerosis (ALS) - DNL343
  • Gene therapy that reduces the rate of abnormal bleeding in eligible people with hemophilia B by enabling the body to continuously produce factor IX, the deficient protein in hemophilia B. - DNL310
  • For MPS IIIA (Sanfilippo Syndrome Type A) - DNL126
  • For Parkinson's Disease - BEACON

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:DNLI) was last updated on 7/9/2025 by MarketBeat.com Staff
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