Relay Therapeutics (NASDAQ:RLAY) stock rallied 41% in morning trading Monday after the drug developer reported positive interim data for its drug candidate RLY-2608 in the treatment of a certain type of breast cancer.
The study demonstrated clinically meaningful progression-free survival for heavily pretreated patients with PI3Kα-mutated, HR+, HER2- locally advanced or metastatic breast cancer given RLY-2608 in combination with fulvestrant, according to a Relay statement.
Relay said it plans to share the data with regulators and align on the design of a pivotal study. The company hopes to begin the study, which will evaluate RLY-2608 with fulvestrant, in 2025.
The company also expects to report initial safety data for RLY-2608 in combination with ribociclib and fulvestrant in Q4 in the treatment of breast cancer. It plans to initiate a study of RLY-2608 plus atirmociclib and fulvestrant by the end of 2024 and triple-dose expansion cohorts for RLY-2608 plus ribociclib and fulvestrant in the first half of 2025.
Relay also anticipates initiating monotherapy solid tumor dose expansion cohorts by the end of 2024, it added.
The company also gave an update for its drug lirafugratinib. Relay said the FDA has suggested the company first file a New Drug Application for the drug in the treatment of cholangiocarcinoma, followed by a tumor agnostic supplemental application for FGFR2 fusions with additional data and more follow up.
Relay added that it intends to seek a commercial partner for lirafugratinib so it can maintain its focus on the rest of its portfolio.
The company said it had approximately $688M in cash and equivalents at the end of Q2, which should sufficiently fund operations into the second half of 2026.