Relay Therapeutics' Drug in the FDA Approval Process
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.
- Drug:
- RLY-2608
- Announced Date:
- June 2, 2025
- Indication:
- For metastatic breast cancer
Announcement
Relay Therapeutics, Inc. announced updated interim clinical data for RLY-2608, the first known investigational allosteric, pan-mutant and isoform-selective inhibitor of PI3Kα.
AI Summary
Relay Therapeutics, Inc. announced updated interim clinical data for RLY-2608, the first investigational allosteric, pan-mutant and isoform-selective inhibitor of PI3Kα. The data, based on a median follow-up of 12.5 months, showed a progression-free survival (PFS) of 11.0 months in second-line patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer treated with RLY-2608 600 mg twice daily plus fulvestrant. The overall median PFS for all patients in the study was 10.3 months. The results support the favorable efficacy and tolerability of this targeted approach, with most treatment-related side effects being low-grade and manageable. These encouraging findings have paved the way for the planned initiation of a Phase 3 trial, expected to begin in mid-2025, and bolster ongoing efforts to evaluate combination therapies with other agents such as CDK4/6 inhibitors. The data will be presented at the ASCO 2025 Annual Meeting.
Read Announcement- Drug:
- RLY-2608
- Announced Date:
- December 11, 2024
- Indication:
- For metastatic breast cancer
Announcement
Relay Therapeutics, Inc announced updated interim clinical data for RLY-2608, the first known investigational allosteric, pan-mutant and isoform-selective inhibitor of PI3Kα.
AI Summary
Relay Therapeutics, Inc. announced updated interim clinical data for RLY-2608, the first investigational allosteric, pan-mutant, and isoform-selective inhibitor of PI3Kα. In a study with patients having PI3Kα-mutated, HR+/HER2- metastatic breast cancer, those receiving RLY-2608 600mg twice daily plus fulvestrant showed a median progression-free survival of 11.4 months in second-line treatment. The data also revealed a 39% confirmed objective response rate overall, with a striking 67% response rate in patients with kinase mutations at the recommended phase 2 dose.
These early results suggest that RLY-2608 could provide significant benefits over non-selective PI3Kα inhibitors. The positive outcomes have laid the groundwork for a planned pivotal second-line study set to start in 2025, offering new hope for a better treatment approach in advanced breast cancer care.
Read Announcement- Drug:
- RLY-2608
- Announced Date:
- December 9, 2024
- Indication:
- For metastatic breast cancer
Announcement
Relay Therapeutics, Inc. announced that updated clinical data for RLY-2608 600mg BID + fulvestrant in patients with PI3Kα-mutated, HR+, HER2- locally advanced or metastatic breast cancer will be presented at the upcoming San Antonio Breast Cancer Symposium, taking place December 10-13, 2024.
AI Summary
Relay Therapeutics, Inc. announced that updated clinical data for its treatment combining RLY-2608 600mg taken twice daily with fulvestrant will be presented at the San Antonio Breast Cancer Symposium. This upcoming event is scheduled for December 10-13, 2024. The presentation will focus on patients with locally advanced or metastatic breast cancer who have PI3Kα-mutated, HR+, HER2- disease. The study, known as the ReDiscover trial, evaluates the efficacy of RLY-2608, a mutant-selective inhibitor designed to target PI3Kα—a kinase often mutated in cancers. The session featuring this data is scheduled on December 11, 2024, with the poster presentation set during a dedicated spotlight session. In addition to the poster, Relay Therapeutics will host a conference call to discuss the findings, providing more insights into this promising precision oncology approach for breast cancer patients.
Read Announcement- Drug:
- RLY-2608
- Announced Date:
- September 9, 2024
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- For metastatic breast cancer
Announcement
Relay Therapeutics, Inc. Triplet combination with ribociclib expected to move into dose expansion in 1H 2025
AI Summary
Relay Therapeutics, Inc. announced plans to advance its triplet combination therapy involving RLY-2608, fulvestrant, and ribociclib. The company expects to begin the dose expansion stage for this triplet treatment in the first half of 2025. This combination is being studied for patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer. Early data from the study suggest that RLY-2608, a novel allosteric and mutant-selective PI3Kα inhibitor, shows promise when combined with current therapies, potentially offering meaningful benefits with a lower toxicity profile.
The dose expansion will follow initial safety evaluations from dose escalation, where biologically active doses of ribociclib have been identified. This next step is part of Relay Therapeutics’ overall effort to improve treatment options for heavily pre-treated breast cancer patients, and the company looks forward to further discussions with regulatory authorities as the study progresses.
Read Announcement- Drug:
- RLY-2608
- Announced Date:
- September 9, 2024
- Indication:
- For metastatic breast cancer
Announcement
Relay Therapeutics, Inc. announced positive interim data for RLY-2608, the first known investigational allosteric, pan-mutant and isoform-selective inhibitor of PI3Kα.
AI Summary
Relay Therapeutics, Inc. announced positive interim data for RLY-2608, marking it as the first investigational allosteric, pan-mutant, and isoform-selective inhibitor of PI3Kα. In the study, heavily pre-treated patients with PI3Kα-mutated, hormone receptor–positive, HER2-negative metastatic breast cancer received RLY-2608 at the recommended Phase 2 dose together with fulvestrant. The results showed a promising median progression-free survival of 9.2 months, with an overall objective response rate of 33% and a notable 53% ORR in patients with kinase mutations. The treatment displayed a favorable tolerability profile, with very few treatment discontinuations and low rates of severe side effects. These encouraging results suggest that by targeting only the mutant form of PI3Kα, RLY-2608 may offer significant benefits while reducing toxicity compared to non-selective inhibitors. The positive data support plans to start a pivotal second-line study in 2025.
Read Announcement- Drug:
- RLY-2608
- Announced Date:
- September 6, 2024
- Estimated Event Date Range:
- September 9, 2024 - September 9, 2024
- Target Action Date:
- September 09, 2024
- Indication:
- For metastatic breast cancer
Announcement
Relay Therapeutics, Inc. announced plans to host a conference call and webcast to report data for RLY-2608 600mg BID + fulvestrant in the ongoing ReDiscover trial in patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer and next steps on Monday, September 9, 2024, at 8:00 a.m. ET.
AI Summary
Relay Therapeutics, Inc. announced it will host a conference call and webcast on Monday, September 9, 2024, at 8:00 a.m. ET. During the call, the company plans to share data from its ongoing ReDiscover trial, which is studying RLY-2608 600mg BID in combination with fulvestrant. This study focuses on patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer who have previously received treatment, including a CDK4/6 inhibitor. The data provided will help inform next steps in the clinical development of RLY-2608, a promising allosteric inhibitor designed to selectively target mutant PI3Kα in cancer cells.
Interested parties can access registration details and dial-in information through Relay Therapeutics’ website under the “News & Events” section. An archived replay of the webcast will be available after the event.
Read Announcement
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
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:RLAY) was last updated on 7/30/2025 by MarketBeat.com Staff
