Relay Therapeutics Shares Rise After Breakthrough Therapy Designation for Zovegalisib
By Chris Wack
Relay Therapeutics shares were 9% higher, at $8.85, after the company said the Food and Drug Administration has granted Breakthrough Therapy Designation to zovegalisib in combination with fulvestrant for the treatment of adults with locally advanced or metastatic breast cancer.
The clinical-stage medicine company said the BTD for zovegalisib was supported by clinical data generated to date from a Phase 1/2 trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of zovegalisib in combination with fulvestrant, and in combination with fulvestrant and CDK inhibitors.
The FDA's BTD is designed to speed up the development and review of therapies for serious conditions when early clinical evidence suggests the potential for substantial improvement over available treatments. BTD provides eligibility for all Fast Track designation features, along with enhanced FDA guidance on development and increased engagement with senior FDA leadership.
The stock hit its 52-week high of $9.04 on Dec. 16, and is 93% higher in the past 12 months.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
February 03, 2026 11:01 ET (16:01 GMT)
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