One To Watch

Relay Therapeutics

A clinical-stage precision oncology company developing small-molecule medicines using a computational and structure-based discovery engine. Its lead program, zovegalisib (RLY-2608), targets PI3Kα in PIK3CA-mutant HR+/HER2- breast cancer.

Headquarters and Global Presence

Relay Therapeutics is headquartered in Cambridge, Massachusetts, and operates as a U.S.-listed public company (Nasdaq: RLAY).

Founding and History

Relay was founded in 2015 to apply advanced computation, structural biology and experimental validation to drug discovery, with an initial focus on oncology targets where conformational dynamics matter for selectivity and tolerability. The company went public in 2020 and has since concentrated resources around its PI3Kα program while out-licensing its FGFR2 program to focus the portfolio.

Therapy Areas and Focus

Relay is focused on oncology, with priority development in:

Breast cancer, specifically PIK3CA-mutant HR+/HER2- locally advanced or metastatic disease
Other solid tumors where targeted pathway inhibition may be clinically differentiated, depending on asset and biomarker strategy

Technology Platforms and Modalities

Relay develops small-molecule targeted therapies, supported by a discovery approach that integrates:

Structure determination (including cryo-EM and other structural methods)
Long-timescale molecular dynamics and computational chemistry to model conformational states
Iterative medicinal chemistry and experimental validation to translate hypotheses into drug candidates

Lead program focus

Zovegalisib (RLY-2608): an allosteric, pan-mutant and isoform-selective PI3Kα inhibitor designed to improve selectivity versus earlier PI3K-pathway inhibitors; being developed primarily in combination with endocrine therapy and, in some settings, CDK inhibition.

Key Personnel

Sanjiv K. Patel, MD, MBA: President and Chief Executive Officer
Tom Catinazzo: Chief Financial Officer

Strategic Partnerships

Elevar Therapeutics: In December 2024, Relay granted Elevar worldwide rights to develop and commercialize lirafugratinib (RLY-4008), its FGFR2 inhibitor program, allowing Relay to prioritize zovegalisib as its core value driver.
Clinical collaboration footprint: Relay’s breast cancer program includes combination development with fulvestrant and evaluation alongside CDK inhibition in defined patient populations.

FAQ Section

Relay applies a structure- and computation-led discovery approach to design small molecules that exploit protein conformational dynamics. The goal is to generate drugs with clinically meaningful selectivity and dosing profiles for targets that have been challenging with conventional inhibitor designs.

Relay is oncology-focused. Its current center of gravity is HR+/HER2- breast cancer with PIK3CA mutations, where PI3Kα pathway inhibition is clinically established but limited by tolerability and resistance dynamics.

Core program

Zovegalisib (RLY-2608): in Phase I/II (ReDiscover) and Phase III (ReDiscover-2) development in PIK3CA-mutant HR+/HER2- advanced breast cancer.

Partnered program

Lirafugratinib (RLY-4008): an FGFR2 inhibitor now licensed to Elevar for global development and commercialization.

February 3, 2026: the U.S. FDA granted Breakthrough Therapy designation to zovegalisib plus fulvestrant for adults with PIK3CA-mutant HR+/HER2- locally advanced or metastatic breast cancer following progression on or after a CDK4/6 inhibitor.
December 2025: Relay reported additional ReDiscover analyses at SABCS 2025, including subset analyses in patients pre-treated with SERD therapy and/or with ESR1 mutations.

Relay’s public data focus has been ReDiscover interim results for zovegalisib plus fulvestrant, including durability and efficacy across clinically relevant subgroups (for example, prior CDK4/6 inhibitor exposure and endocrine-resistance features). Updates have also highlighted dose and regimen refinements supporting Phase III selection.

Near-term milestones center on execution of the Phase III ReDiscover-2 trial and continued maturation of ReDiscover datasets in defined breast cancer subgroups. Regulatory progress will be driven by Phase III enrollment, event accrual and the strength of benefit-risk versus relevant comparators.

Relay positions zovegalisib as an allosteric, mutant-selective PI3Kα inhibitor intended to improve therapeutic index and clinical utility in PIK3CA-mutant disease. Differentiation is expected to rest on tolerability, dose intensity, and durability of benefit in heavily pre-treated endocrine-resistant populations.

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