Grail (GRAL) faces an "incrementally positive" shift toward a narrower and more focused Food and Drug Administration debate ahead of Wednesday's advisory committee meeting on Galleri, its multicancer early detection test, UBS Securities said in a report.
The FDA briefing documents show the agency has no major outstanding questions about Galleri's analytical performance, bridging analyses or primary safety results, UBS said Monday in the report. Instead, the panel discussion is expected to center on how the test should be positioned and labeled.
A key issue is whether Galleri's stage-specific performance supports an "early detection" claim and how broadly any clinical benefit should be reflected in the final indication, the report said. UBS said it still expects FDA approval.
UBS reiterated its buy rating on Grail stock with a $105 price target.
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