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Ionis Pharmaceuticals (IONS) FDA Events

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FDA Events for Ionis Pharmaceuticals (IONS)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Ionis Pharmaceuticals (IONS). Over the past two years, Ionis Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as BIIB080/IONIS-MAPT, Donidalorsen, Eplontersen, ION373, ION582, Olezarsen, and Zilganersen. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Ionis Pharmaceuticals' Drugs in FDA Review

BIIB080/IONIS-MAPT - FDA Regulatory Timeline and Events

BIIB080/IONIS-MAPT is a drug developed by Ionis Pharmaceuticals for the following indication: Mild Alzheimer'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.

Donidalorsen (formerly IONIS-PKK-LRx) - FDA Regulatory Timeline and Events

Donidalorsen (formerly IONIS-PKK-LRx) is a drug developed by Ionis Pharmaceuticals for the following indication: Hereditary angioedema (HAE). 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.

Eplontersen - FDA Regulatory Timeline and Events

Eplontersen is a drug developed by Ionis Pharmaceuticals for the following indication: Treatment for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). 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.

ION373 - FDA Regulatory Timeline and Events

ION373 is a drug developed by Ionis Pharmaceuticals for the following indication: Alexander 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.

ION582 - FDA Regulatory Timeline and Events

ION582 is a drug developed by Ionis Pharmaceuticals for the following indication: Angelman 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.

Olezarsen (Formerly IONIS-APOCIII-L) - FDA Regulatory Timeline and Events

Olezarsen (Formerly IONIS-APOCIII-L) is a drug developed by Ionis Pharmaceuticals for the following indication: Severe hypertriglyceridemia. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Zilganersen - FDA Regulatory Timeline and Events

Zilganersen is a drug developed by Ionis Pharmaceuticals for the following indication: for the treatment of children and adults Alexander disease (AxD). 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.

Ionis Pharmaceuticals FDA Events - Frequently Asked Questions

Yes, Ionis Pharmaceuticals (IONS) has received FDA approval for Olezarsen (Formerly IONIS-APOCIII-L). This page tracks recent and historical FDA regulatory events related to Ionis Pharmaceuticals' drug portfolio.

In the past two years, Ionis Pharmaceuticals (IONS) has reported FDA regulatory activity for the following drugs: Olezarsen (Formerly IONIS-APOCIII-L), ION582, Eplontersen, Donidalorsen (formerly IONIS-PKK-LRx), BIIB080/IONIS-MAPT, Zilganersen and ION373.

The most recent FDA-related event for Ionis Pharmaceuticals occurred on June 11, 2025, involving ION582. The update was categorized as "Enrollment Completion," with the company reporting: "Ionis Pharmaceuticals, Inc. announced that Completion of enrollment anticipated in 2026"

Current therapies from Ionis Pharmaceuticals in review with the FDA target conditions such as:

  • Severe hypertriglyceridemia - Olezarsen (Formerly IONIS-APOCIII-L)
  • Angelman syndrome - ION582
  • Treatment for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). - Eplontersen
  • Hereditary angioedema (HAE) - Donidalorsen (formerly IONIS-PKK-LRx)
  • Mild Alzheimer's disease - BIIB080/IONIS-MAPT
  • for the treatment of children and adults Alexander disease (AxD). - Zilganersen
  • Alexander disease - ION373

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:IONS) was last updated on 7/10/2025 by MarketBeat.com Staff
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