Stock prices for cancer testing company Grail tumbled almost 50% during pre-market hours Friday following disappointing results from a comprehensive three-year clinical study that did not achieve its primary endpoint.
This disappointing outcome arrives shortly after Grail submitted an application to federal regulators seeking approval for its Galleri blood test, using information from both a smaller domestic study and initial data from the extensive three-year research project.
The comprehensive study aimed to demonstrate whether the blood test could decrease diagnoses of advanced-stage cancers while improving early detection rates within England’s National Health Service, potentially informing decisions about implementing a nationwide screening initiative.
Following Thursday’s market close, Grail announced that while the study did not achieve statistically significant reduction in late-stage cancer detection, “a favorable trend was observed over time” throughout the research involving more than 142,000 participants between ages 50 and 77 within the NHS system.
The biotechnology firm had filed its premarket approval request with the U.S. Food and Drug Administration in late January, utilizing results from approximately 25,000 American participants along with first-year findings from the NHS-Galleri study.
Currently, the Galleri multi-cancer detection test is already available for adults at higher cancer risk, particularly those 50 years and older.
Financial analyst Kyle Mikson from Canaccord Genuity noted that while FDA clearance for Galleri doesn’t seem to face significant risk, questions remain about whether the Centers for Medicare and Medicaid Services will factor in the NHS results when establishing coverage guidelines.
President Donald Trump recently enacted legislation this month that will allow Medicare insurance plans to cover multi-cancer detection tests for senior citizens beginning in 2028, with eligibility based on age requirements.
“We believe it is relatively likely that CMS will emphasize U.S.-based studies… rather than the specific endpoints that NHS established,” Mikson stated.
