Relay Therapeutics Stock Jumps on FDA Drug Status

FDA Grants Breakthrough Status to Cancer Drug

Relay Therapeutics Inc (NASDAQ:RLAY) stock rose 3.8% in premarket trading after the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to its cancer treatment, zovegalisib. The designation is for its use in combination with fulvestrant for a specific type of advanced breast cancer.

Situation Overview

The designation applies to adults with PIK3CA mutant, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer who have progressed after treatment with a CDK4/6 inhibitor. According to Relay Therapeutics, approximately 40% of patients in this group have PIK3CA mutations and limited treatment options. The Breakthrough Therapy status is designed to expedite the development and review of drugs for serious conditions that show potential for substantial improvement over existing therapies.

Market and Economic Impact

The immediate market reaction was positive, reflected in the 3.8% premarket stock increase. This FDA designation provides the company with enhanced guidance and a more collaborative review process, potentially shortening the timeline to drug approval and commercialization. The decision was supported by clinical data from the company’s Phase 1/2 ReDiscover trial.

Next Steps for Zovegalisib

Relay Therapeutics is scheduled to present initial data from its Phase 1/2 trial at the ESMO Targeted Anticancer Therapies Congress on March 16. The company is also moving forward with its ongoing Phase 3 trial, ReDiscover-2, which will be crucial for the drug's future regulatory submissions and market potential.

FAQ

Q: Why did Relay Therapeutics' stock rise?
A: The stock increased after its cancer drug, zovegalisib, received Breakthrough Therapy designation from the FDA, which could accelerate its development and review process.

Q: What is Breakthrough Therapy designation?
A: It is a process designed by the FDA to expedite the development and review of drugs intended to treat a serious condition, where preliminary clinical evidence indicates substantial improvement over available therapy.

Source: Investing.com