Relay Therapeutics shares climbed 9% after the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to its experimental drug zovegalisib for the treatment of advanced breast cancer. The designation applies to the drug when used in combination with fulvestrant for patients with locally advanced or metastatic cases.
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.
Comments (0)
No comments yet. Be the first!