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Denali Therapeutics (DNLI) FDA Approvals

Denali Therapeutics logo
$18.64 -0.66 (-3.42%)
Closing price 05/22/2026 04:00 PM Eastern
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$18.86 +0.22 (+1.20%)
As of 05/22/2026 07:58 PM Eastern
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Denali Therapeutics' Drugs in the FDA Approval Process

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 DNL151, DNL593, AVLAYAH, tividenofusp, DNL310, tividenofusp, and DNL343. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

DNL151 FDA Regulatory Events

DNL151 is a drug developed by Denali Therapeutics for the following indication: 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.

DNL593 (PTV:PGRN) FDA Regulatory Events

DNL593 (PTV:PGRN) is a drug developed by Denali Therapeutics for the following indication: Frontotemporal Dementia-Granulin (FTD-GRN). 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.

AVLAYAH FDA Regulatory Events

AVLAYAH is a drug developed by Denali Therapeutics for the following indication: 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.

Tividenofusp alfa FDA Regulatory Events

Tividenofusp alfa is a drug developed by Denali Therapeutics for the following indication: Treatment For Hunter Syndrome. 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.

Tividenofusp FDA Regulatory 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.

DNL343 FDA Regulatory 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.

DNL126 FDA Regulatory 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.

BEACON FDA Regulatory 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.

Denali Therapeutics FDA Events - Frequently Asked Questions

In the past two years, Denali Therapeutics (DNLI) has not received FDA approval for any therapies. However, the company does have 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: DNL310, tividenofusp, DNL343, tividenofusp alfa, DNL126, DNL151, DNL593 (PTV:PGRN), AVLAYAH and BEACON.

The most recent FDA-related event for Denali Therapeutics occurred on May 21, 2026, involving DNL151. The update was categorized as "Positive Results," with the company reporting: "Biogen Inc. and Denali Therapeutics Inc. announced topline results from the Phase 2b LUMA study evaluating BIIB122 (DNL151), an investigational small molecule inhibitor of LRRK2 (leucine-rich repeat kinase 2), in individuals with early-stage Parkinson's disease."

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

  • 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 the treatment of Hunter syndrome (MPS II) - tividenofusp
  • Amyotrophic lateral sclerosis (ALS) - DNL343
  • Treatment For Hunter Syndrome - tividenofusp alfa
  • For MPS IIIA (Sanfilippo Syndrome Type A) - DNL126
  • Parkinson's Disease - DNL151
  • Frontotemporal Dementia-Granulin (FTD-GRN) - DNL593 (PTV:PGRN)
  • Treatment of Hunter Syndrome (MPS II) - AVLAYAH
  • 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

FDA progress for NASDAQ:DNLI last updated on 5/22/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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