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23andMe (ME) FDA Events

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FDA Events for 23andMe (ME)

This section highlights FDA-related milestones and regulatory updates for drugs developed by 23andMe (ME). Over the past two years, 23andMe has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as 23ME-00610. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

23ME-00610 - FDA Regulatory Timeline and Events

23ME-00610 is a drug developed by 23andMe for the following indication: Advanced solid tumors. 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.

23andMe FDA Events - Frequently Asked Questions

As of now, 23andMe (ME) has not received any FDA approvals for its therapy in the last two years.

In the past two years, 23andMe (ME) has reported FDA regulatory activity for 23ME-00610.

The most recent FDA-related event for 23andMe occurred on September 15, 2024, involving 23ME-00610. The update was categorized as "Efficacy and Safety Data," with the company reporting: "23andMe Holding Co. announced positive preliminary Phase 2 safety and efficacy data from its Phase 1/2a clinical trial covering two new patient cohorts from 23ME-00610 ('610), a first-in-class anti-CD200R1 antibody, at the European Society of Medical Oncology (ESMO) Congress 2024 in Barcelona, September 13-17."

Currently, 23andMe has one therapy (23ME-00610) targeting the following condition: Advanced solid tumors.

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