Relay Therapeutics, Inc. (RLAY) on Tuesday said the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to zovegalisib in combination with fulvestrant for the treatment of adults with PIK3CA-mutant, HR+/HER2- advanced breast cancer.
Following the announcement, Relay Therapeutics shares rose more than 3% in pre-market trading, after closing at $8.15, up 6.4% in the previous session.
The BTD was supported by clinical data from the Phase 1/2 ReDiscover trial, which is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of zovegalisib in combination with fulvestrant, as well as in combination with fulvestrant and CDK inhibitors.
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January 30, 2026 15:51 ET The Federal Reserve policy decision was the main event in the final week of January, which saw a heavy flow of economics news. Several data reflecting the trends in the U.S. economy were also released during the week. The interest rate decision from Canada also was in focus. In Europe, economic sentiment data gained attention. The policy decision from Singapore was the highlight in Asia.