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Fate Therapeutics (FATE) FDA Events

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FDA Events for Fate Therapeutics (FATE)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Fate Therapeutics (FATE). Over the past two years, Fate Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as FT522 and FT819. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Fate Therapeutics' Drugs in FDA Review

FT522 - FDA Regulatory Timeline and Events

FT522 is a drug developed by Fate Therapeutics for the following indication: In relapsed / refractory B-cell lymphoma. 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.

FT819 - FDA Regulatory Timeline and Events

FT819 is a drug developed by Fate Therapeutics for the following indication: Advanced B-cell Leukemias and Lymphomas. 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.

Fate 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, Fate Therapeutics (FATE) has reported FDA regulatory activity for the following drugs: FT819 and FT522.

The most recent FDA-related event for Fate Therapeutics occurred on June 11, 2025, involving FT819. The update was categorized as "Updated data," with the company reporting: "Fate Therapeutics, Inc. announced new and updated clinical data from the first five patients dosed with FT819 for the treatment of moderate-to-severe systemic lupus erythematosus (SLE) at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress in Barcelona, Spain."

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

  • Advanced B-cell Leukemias and Lymphomas - FT819
  • In relapsed / refractory B-cell lymphoma - FT522

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:FATE) was last updated on 7/11/2025 by MarketBeat.com Staff
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