Earnings summaries and quarterly performance for Relay Therapeutics.
Executive leadership at Relay Therapeutics.
Board of directors at Relay Therapeutics.
Research analysts covering Relay Therapeutics.
Recent press releases and 8-K filings for RLAY.
Relay Therapeutics Reports Q4 and Full Year 2025 Financial Results, Outlines 2026 Milestones
RLAY
Earnings
Guidance Update
New Projects/Investments
- Relay Therapeutics, Inc. reported $554.5 million in cash, cash equivalents, and investments as of December 31, 2025, and expects this to fund its operating expenses and capital expenditure requirements into 2029.
- For the fourth quarter of 2025, the company generated $7.0 million in revenue and recorded a net loss of $54.9 million, or $0.32 per share. For the full year 2025, revenue was $15.4 million, with a net loss of $276.5 million, or $1.61 per share.
- Key anticipated milestones for 2026 include the announcement of initial Phase 1 data for zovegalisib in PIK3CA-driven vascular anomalies in the first half of 2026, and updates on breast cancer triplet data and frontline Phase 3 plans.
- Initial Phase 1/2 data of zovegalisib + fulvestrant at the Phase 3 dose in CDK4/6-experienced breast cancer patients will be presented at ESMO TAT on March 16, 2026.
1 day ago
Relay Therapeutics' Zovegalisib Receives FDA Breakthrough Therapy Designation
RLAY
New Projects/Investments
- Relay Therapeutics' zovegalisib (RLY-2608) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for adults with PIK3CA-mutant HR+/HER2- advanced or metastatic breast cancer after recurrence or progression on CDK4/6 inhibitors.
- The decision was based on encouraging Phase 1/2 ReDiscover data showing safety, tolerability, and preliminary antitumor activity.
- This designation is intended to accelerate the drug's development and review, providing benefits such as eligibility for Fast Track designation features, enhanced FDA guidance, and increased engagement with senior FDA leadership.
- Following the announcement, Relay's shares rose, with some analysts upgrading their ratings and a consensus average price target of $16.57.
Feb 3, 2026, 12:33 PM
Relay Therapeutics' Zovegalisib Granted Breakthrough Therapy Designation by FDA
RLAY
- Relay Therapeutics, Inc. announced on February 3, 2026, that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation (BTD) to zovegalisib (RLY-2608).
- This designation is for zovegalisib in combination with fulvestrant for the treatment of adults with PIK3CA mutant hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor.
- The BTD was supported by clinical data from the Phase 1/2 ReDiscover trial and is designed to accelerate the development and review of therapies for serious conditions, offering enhanced FDA guidance.
Feb 3, 2026, 12:10 PM
Relay Therapeutics' Zovegalisib Receives FDA Breakthrough Therapy Designation
RLAY
- On February 3, 2026, Relay Therapeutics announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation (BTD) to zovegalisib (RLY-2608).
- The BTD is for zovegalisib in combination with fulvestrant for the treatment of adults with PIK3CA mutant, hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor.
- This designation aims to accelerate the development and review of therapies for serious conditions, providing eligibility for Fast Track designation features, enhanced FDA guidance, and increased engagement with senior FDA leadership.
- The BTD was supported by robust clinical data from the Phase 1/2 ReDiscover trial, which evaluated zovegalisib in combination with fulvestrant.
- Initial Phase 1/2 data for zovegalisib + fulvestrant at the 400mg BID fed dose (the Phase 3 dose) in CDK4/6-experienced patients will be presented at the ESMO Targeted Anticancer Therapies Congress on March 16, 2026.
Feb 3, 2026, 12:00 PM
Elevar Therapeutics Submits NDA for Lirafugratinib
RLAY
Product Launch
- Elevar Therapeutics submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on January 28, 2026, for its investigational drug lirafugratinib.
- Lirafugratinib is proposed as a second-line treatment option for cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement.
- The NDA is supported by positive clinical data from the phase 1/2 ReFocus trial, which showed an independent review committee-assessed Objective Response Rate (ORR) of 46.5%, median Duration of Response (DoR) of 11.8 months, and median Progression-Free Survival (PFS) of 11.3 months.
- Elevar Therapeutics acquired worldwide rights to develop and commercialize lirafugratinib in December 2024, following earlier discussions between Relay Therapeutics and the FDA in 2024 regarding the ReFocus trial data.
Jan 28, 2026, 10:04 PM
Relay Therapeutics announces positive zovegalisib efficacy data from ReDiscover study subset analysis
RLAY
New Projects/Investments
- Relay Therapeutics presented a subset analysis of interim clinical data for zovegalisib (RLY-2608), an investigational PI3Kα inhibitor, at the 2025 San Antonio Breast Cancer Symposium.
- The data showed a 10.3-month median Progression-Free Survival (PFS) for all patients and 11.4-month median PFS for second-line (2L) patients.
- Efficacy was consistent across subgroups, including patients with prior SERD exposure (median PFS 11.4 months, ORR 44%) and those with detectable ESR1 mutations (median PFS 8.8 months, ORR 60%).
- The company is continuing enrollment in the Phase 3 ReDiscover-2 trial for breast cancer and the Phase 1/2 ReInspire clinical trial for vascular malformations.
Dec 12, 2025, 12:00 PM
Relay Therapeutics Provides Update on RLY-2608 Phase 3 Progress and Financial Position
RLAY
New Projects/Investments
Guidance Update
- Relay Therapeutics is in execution mode for its Phase 3 asset, RLY-2608, a PI3K alpha mutant selective inhibitor, which has shown a 39% ORR and 10.3-month PFS (11 months in pure second line).
- The company is confident that RLY-2608 will be successful in the second-line setting, aiming for a 2-3 month PFS delta over Capivasertib.
- Relay Therapeutics has close to $600 million on its balance sheet, providing a cash runway into 2029, which supports ongoing trials including Rediscovery II (Phase 3), triplet data, and vascular malformations programs.
- The company is also exploring triplet regimens for earlier breast cancer treatment and has commenced dosing patients with PI3K alpha-driven vascular malformations.
Nov 19, 2025, 11:30 AM
Relay Therapeutics Provides Update on RLY-2608 Phase 3 Progress and Pipeline
RLAY
New Projects/Investments
- Relay Therapeutics is in execution mode with its Phase 3 asset RLY-2608, a PI3K alpha mutant selective inhibitor, for breast cancer, targeting a 10-month PFS in the second-line setting against a competitive bar of 5.5 to 7 months.
- The company has commenced dosing patients with PI3K alpha-driven vascular malformations with RLY-2608, representing a significant opportunity with 170,000 patients across all types of vascular malformations.
- Relay Therapeutics maintains a strong financial position with close to $600 million on its balance sheet, providing a cash runway into 2029 to support ongoing clinical trials and pipeline development.
- RLY-2608 is being compared against Capivasertib in the Rediscovery II study, with an internal target of a two to three-month delta in PFS, and is differentiated by its 400-mg BID Fed dose and a potentially cleaner safety profile, particularly regarding hyperglycemia, compared to other PI3K alpha inhibitors.
Nov 19, 2025, 11:30 AM
Relay Therapeutics Provides Update on RLY-2608 Phase III Progress and Pipeline
RLAY
New Projects/Investments
Guidance Update
- Relay Therapeutics is in Phase III with its PI3K alpha mutant selective inhibitor, RLY-2608, for breast cancer, targeting a 10-month PFS (11 months in second-line only) against Capivasertib, which has a 5.5-7 month PFS. The ReDiscover-2 study is powered for a 2-3 month delta over Capivasertib.
- RLY-2608 will use a 400-mg BID Fed dose, which maintains similar PK coverage to previous doses. The company anticipates lower hyperglycemia rates compared to other PI3K alphas, and at-home glucose monitoring is not required for RLY-2608 in the ReDiscover-2 study.
- The company has commenced dosing patients for PI3K alpha-driven vascular malformations, utilizing a dose randomization approach across three doses, aiming for improved efficacy and tolerability compared to existing treatments.
- Relay Therapeutics holds close to $600 million on its balance sheet, providing a cash runway into 2029.
Nov 19, 2025, 11:30 AM
Relay Therapeutics Discusses RLY-2608 Clinical Progress and Market Opportunities
RLAY
New Projects/Investments
Product Launch
Guidance Update
- Relay Therapeutics is advancing RLY-2608, a PI3Kα mutant selective inhibitor, with a pivotal trial in post-CDK4/6 metastatic breast cancer started this summer, and ongoing trials for frontline metastatic breast cancer and vascular malformations.
- RLY-2608 demonstrates a superior clinical profile in breast cancer compared to capivasertib, showing double-digit progression-free survival (PFS) versus 5.5 months for capivasertib, and a 39% confirmed objective response rate compared to 20% for a competitor molecule.
- The company sees a significant commercial opportunity for RLY-2608 in vascular malformations, targeting an estimated 170,000 PI3Kα mutant patients in the U.S., with potential for a multi-billion dollar market.
- Relay Therapeutics has a cash runway extending into 2029.
Nov 10, 2025, 4:00 PM
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