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CRISPR Therapeutics (CRSP) FDA Events

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FDA Events for CRISPR Therapeutics (CRSP)

This section highlights FDA-related milestones and regulatory updates for drugs developed by CRISPR Therapeutics (CRSP). Over the past two years, CRISPR Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CTX112 and CTX310. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

CRISPR Therapeutics' Drugs in FDA Review

CTX112 - FDA Regulatory Timeline and Events

CTX112 is a drug developed by CRISPR Therapeutics for the following indication: In relapsed or refractory (R/R) CD19-positive B-cell malignancies. 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.

CTX310 - FDA Regulatory Timeline and Events

CTX310 is a drug developed by CRISPR Therapeutics for the following indication: Treatments for Cardiovascular Diseases. 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.

CRISPR 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, CRISPR Therapeutics (CRSP) has reported FDA regulatory activity for the following drugs: CTX310 and CTX112.

The most recent FDA-related event for CRISPR Therapeutics occurred on June 26, 2025, involving CTX310. The update was categorized as "Clinical Update," with the company reporting: "CRISPR Therapeutics announced updates across its in vivo cardiovascular disease programs."

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

  • Treatments for Cardiovascular Diseases - CTX310
  • In relapsed or refractory (R/R) CD19-positive B-cell malignancies - CTX112

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