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Cellectis (CLLS) FDA Events

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FDA Events for Cellectis (CLLS)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Cellectis (CLLS). Over the past two years, Cellectis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as TALEN® and UCART22. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Cellectis' Drugs in FDA Review

TALEN® - FDA Regulatory Timeline and Events

TALEN® is a drug developed by Cellectis for the following indication: For triple negative breast cancer (TNBC). 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.

UCART22 - FDA Regulatory Timeline and Events

UCART22 is a drug developed by Cellectis for the following indication: For patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia. 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.

Cellectis FDA Events - Frequently Asked Questions

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

In the past two years, Cellectis (CLLS) has reported FDA regulatory activity for the following drugs: UCART22 and TALEN®.

The most recent FDA-related event for Cellectis occurred on September 3, 2024, involving TALEN®. The update was categorized as "Publication," with the company reporting: "Cellectis today published a scientific article in Science Advances suggesting that TALEN®-edited MUC1 CAR T-cells could be a potential treatment option for advance-stage triple negative breast cancer (TNBC) patients with limited therapeutic options."

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

  • For patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia - UCART22
  • For triple negative breast cancer (TNBC) - TALEN®

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