Relay Thera’s zovegalisib wins ‘Breakthrough’ status from FDA

Cambridge, USA-based precision medicines specialist Relay Therapeutics (Nasdaq: RLAY) today announced that the US. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to zovegalisib (RLY-2608) in combination with fulvestrant 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 following recurrence or progression on or after treatment with a CDK4/6 inhibitor.

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.

“Approximately 40% of patients with HR+/HER2- advanced breast cancer harbor PIK3CA mutations, and most experience disease recurrence or progression following treatment with CDK4/6 inhibitors, leaving limited therapeutic options,” said Dr Don Bergstrom, president of R&D at Relay Therapeutics, adding: “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 we have demonstrated to date. We look forward to continuing to collaborate closely with the FDA as we work to advance this program as efficiently as possible for patients.”