The clinical-stage biotechnology company reported that the FDA's decision was supported by data from an ongoing Phase 1/2 trial. This study evaluated the safety, tolerability, and preliminary antitumor activity of zovegalisib in combination with fulvestrant, as well as in regimens including CDK inhibitors.

Following the announcement, Relay Therapeutics shares rose to $8.85, continuing a period of significant momentum. The stock previously reached a 52-week high of $9.04 on Dec. 16, and has gained approximately 93% over the past 12 months as clinical progress bolstered investor confidence.

The Breakthrough Therapy Designation is a regulatory mechanism intended to expedite the development and review of medicines for serious conditions where early evidence suggests a substantial improvement over existing treatments. This status provides the company with enhanced FDA guidance and increased engagement with senior agency leadership to move the therapy toward potential approval.