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Editas Medicine (EDIT) FDA Events

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FDA Events for Editas Medicine (EDIT)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Editas Medicine (EDIT). Over the past two years, Editas Medicine has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as EDIT-301 and EDIT-301. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Editas Medicine's Drugs in FDA Review

EDIT-301 - FDA Regulatory Timeline and Events

EDIT-301 is a drug developed by Editas Medicine for the following indication: Transfusion-Dependent Beta Thalassemia. 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.

EDIT-301 (RUBY) - FDA Regulatory Timeline and Events

EDIT-301 (RUBY) is a drug developed by Editas Medicine for the following indication: Sickle Cell 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.

Editas Medicine FDA Events - Frequently Asked Questions

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

In the past two years, Editas Medicine (EDIT) has reported FDA regulatory activity for the following drugs: EDIT-301 (RUBY) and EDIT-301.

The most recent FDA-related event for Editas Medicine occurred on December 9, 2024, involving EDIT-301 (RUBY). The update was categorized as "Efficacy and Safety Data," with the company reporting: "Editas Medicine, Inc.will present updated safety and efficacy data in 28 patients living with severe sickle cell disease (SCD) treated with renizgamglogene autogedtemcel (reni-cel; formerly known as EDIT-301) in the Phase 1/2/3 RUBY clinical trial."

Current therapies from Editas Medicine in review with the FDA target conditions such as:

  • Sickle Cell Disease - EDIT-301 (RUBY)
  • Transfusion-Dependent Beta Thalassemia - EDIT-301

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