Relay Thera’s Zovegalisib Wins FDA ‘Breakthrough’ Status
- Stock Move: +6% ($8.65)
- Consensus: Moderate Buy
- Avg Price Target: $16.57
- Wells Fargo: Overweight ($13)
- Oppenheimer: Outperform ($14)
Cambridge, USA-based precision medicines specialist Relay Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to zovegalisib (RLY-2608) in combination with fulvestrant.
Indication and Patient Population
The BTD is for the treatment of adults with PIK3CA mutant, hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. This designation specifically covers patients following recurrence or progression on or after treatment with a CDK4/6 inhibitor.
— Dr. Don Bergstrom, President of R&D, Relay Therapeutics
Market Impact and Analyst Activity
Relay’s shares gained more than 6% to $8.65 on the news. Recent analyst activity includes upgrades from Wells Fargo (to overweight, $13 target) and Oppenheimer (to outperform, $14 target); the consensus is a Moderate Buy with an average price target of $16.57.
Significance of FDA Recognition
Dr. Bergstrom added that this Breakthrough Therapy designation underscores the FDA’s recognition of the potential of zovegalisib in combination with fulvestrant to meaningfully improve outcomes for these patients, reinforcing the impact of the encouraging clinical evidence demonstrated to date.
Relay Therapeutics looks forward to continuing to collaborate closely with the FDA as they work to advance this program as efficiently as possible for patients.
