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Adaptimmune Therapeutics (ADAP) FDA Events

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FDA Events for Adaptimmune Therapeutics (ADAP)

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

Adaptimmune Therapeutics' Drugs in FDA Review

Afamitresgene autoleucel (afami-cel, formerly ADP-A2M4) - FDA Regulatory Timeline and Events

Afamitresgene autoleucel (afami-cel, formerly ADP-A2M4) is a drug developed by Adaptimmune Therapeutics for the following indication: Advanced synovial sarcoma or MRCLS. 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.

lete-cel - FDA Regulatory Timeline and Events

lete-cel is a drug developed by Adaptimmune Therapeutics for the following indication: For Myxoid/Round Cell Liposarcoma. 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.

Adaptimmune 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, Adaptimmune Therapeutics (ADAP) has reported FDA regulatory activity for the following drugs: lete-cel and Afamitresgene autoleucel (afami-cel, formerly ADP-A2M4).

The most recent FDA-related event for Adaptimmune Therapeutics occurred on January 13, 2025, involving lete-cel. The update was categorized as "Designation Grant," with the company reporting: "Adaptimmune Therapeutics plc announced that letetresgene autoleucel (lete-cel), has been granted breakthrough therapy designation by the U.S. FDA for the treatment of patients with unresectable or metastatic myxoid/round cell liposarcoma (MRCLS) who have received prior anthracycline-based chemotherapy, are positive for HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06, and whose tumor expresses the NY-ESO-1 antigen."

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

  • For Myxoid/Round Cell Liposarcoma - lete-cel
  • Advanced synovial sarcoma or MRCLS - Afamitresgene autoleucel (afami-cel, formerly ADP-A2M4)

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