Relay Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to zovegalisib (RLY-2608) 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 designation was supported by clinical data from the Phase 1/2 ReDiscover trial, which evaluated zovegalisib in combination with fulvestrant at two dose levels. Initial data from this combination at the 400mg BID fed dose in CDK4/6-experienced patients will be presented at the ESMO Targeted Anticancer Therapies Congress on March 16.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Relay Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9647240) on February 03, 2026, and is solely responsible for the information contained therein.