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Adaptive Biotechnologies (ADPT) FDA Events

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FDA Events for Adaptive Biotechnologies (ADPT)

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

clonoSEQ - FDA Regulatory Timeline and Events

clonoSEQ is a drug developed by Adaptive Biotechnologies for the following indication: Treatments for patients with lymphoid 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.

Adaptive Biotechnologies FDA Events - Frequently Asked Questions

As of now, Adaptive Biotechnologies (ADPT) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Adaptive Biotechnologies (ADPT) has reported FDA regulatory activity for clonoSEQ.

The most recent FDA-related event for Adaptive Biotechnologies occurred on July 1, 2025, involving clonoSEQ. The update was categorized as "Provided Update," with the company reporting: "Adaptive Biotechnologies announced the integration of Adaptive's clonoSEQ® test for measurable residual disease (MRD) assessment in lymphoid malignancies into OncoEMR®, Flatiron's cloud-based Electronic Medical Record (EMR) platform."

Currently, Adaptive Biotechnologies has one therapy (clonoSEQ) targeting the following condition: Treatments for patients with lymphoid malignancies..

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