Guardant falls after FDA briefing documents for camizestrant

Shares of Guardant Health (GH) are moving lower after the FDA posted briefing documents for AstraZeneca’s (AZN) camizestrant ahead of the committee meeting on April 30. Guardant’s G360 test is being used to detect mutations in camizestrant’s SERENA-6 Phase 3 trial. Given that the trial is not adequately powered for overall survival, definitive conclusions about survival benefit may not be able to be drawn from SERENA-6, the FDA panel said in the documents. “Despite the formal inclusion of PFS2 in the statistical hierarchy, FDA generally does not consider PFS2 acceptable for regulatory decision-making, as communicated to the Applicant in the February 8, 2021,” it added. The panel said, “The FDA is uncertain whether SERENA-6 has demonstrated a clinically meaningful benefit for camizestrant in patients with HR+HER2- ABC upon detection of an ESR1m, prior to radiographic progression.” Shares of Guardant are down 5% to $84.08 in afternoon trading.