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.
- Drug:
- 23ME-00610
- Announced Date:
- September 15, 2024
- Indication:
- Advanced solid tumors
Announcement
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.
AI Summary
At the ESMO Congress 2024 in Barcelona, 23andMe Holding Co. announced positive preliminary Phase 2 safety and efficacy data from the Phase 1/2a clinical trial of its 23ME-00610 treatment. This first-in-class anti-CD200R1 antibody showed promising results in two new patient cohorts. In particular, the trial demonstrated clinical benefit in patients with clear-cell renal-cell carcinoma, including a confirmed partial response in one patient. The study also observed that higher tumor expression of CD200, along with specific human genetic markers, could predict better outcomes. Additionally, patients with “cold” tumors, who typically do not respond to PD-1/PD-L1 therapies, showed a greater response to 23ME-00610. These encouraging findings suggest that interrupting the CD200/CD200R1 pathway may help reverse immune suppression within the tumor environment, potentially offering a new treatment option for advanced cancers.
Read Announcement- Drug:
- 23ME-00610
- Announced Date:
- September 3, 2024
- Indication:
- Advanced solid tumors
Announcement
23andMe Holding Co announced that it will display three poster presentations on 23ME-00610, a first-in-class anti-CD200R1 antibody, and two on 23ME-01473, an anti-ULBP6 monoclonal antibody, at the European Society for Medical Oncology (ESMO) Congress 2024, taking place September 13 – September 17 in Barcelona, Spain.
AI Summary
23andMe Holding Co. announced that it will present new research at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, from September 13 to September 17. The company is set to showcase three poster presentations featuring 23ME-00610, a first-in-class anti-CD200R1 antibody, and two poster presentations on 23ME-01473, an anti-ULBP6 monoclonal antibody. These sessions will highlight both clinical and preclinical data. The posters on 23ME-00610 will share insights into its potential efficacy and safety in treating advanced solid cancers, while the sessions on 23ME-01473 will cover preclinical findings and ongoing trial progress, illustrating its role in restoring anti-tumor immune responses. This presentation underscores 23andMe’s commitment to advancing cancer immunotherapies using targets identified from their extensive human genetics database.
Read Announcement
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
FDA Event Stage Terminology & Abbreviation Guide
- 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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