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Relay Therapeutics (RLAY) FDA Events

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FDA Events for Relay Therapeutics (RLAY)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Relay Therapeutics (RLAY). Over the past two years, Relay Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as RLY-2608. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

RLY-2608 - FDA Regulatory Timeline and Events

RLY-2608 is a drug developed by Relay Therapeutics for the following indication: For metastatic breast cancer. 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.

Relay Therapeutics FDA Events - Frequently Asked Questions

As of now, Relay Therapeutics (RLAY) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Relay Therapeutics (RLAY) has reported FDA regulatory activity for RLY-2608.

The most recent FDA-related event for Relay Therapeutics occurred on June 2, 2025, involving RLY-2608. The update was categorized as "Updated data," with the company reporting: "Relay Therapeutics, Inc. announced updated interim clinical data for RLY-2608, the first known investigational allosteric, pan-mutant and isoform-selective inhibitor of PI3Kα."

Currently, Relay Therapeutics has one therapy (RLY-2608) targeting the following condition: For metastatic breast cancer.

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:RLAY) was last updated on 7/9/2025 by MarketBeat.com Staff
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