Grail Shares Surge 33% on FDA Signals for Galleri Test — SkimNews
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- Grail's shares surged 33% Monday after the FDA posted documents ahead of an advisory committee meeting suggesting the agency may view the Galleri test favorably
- The advisory committee meeting is scheduled for Wednesday and will bring together key experts to discuss Galleri, a blood test designed to detect many types of cancer early when they can be treated more effectively
- Investors had already been bidding up Grail's stock in anticipation of the meeting before Monday's 33% surge
- The FDA is not obligated to follow advisory committee recommendations, but it often does
- Galleri is already available as a laboratory-based diagnostic, and FDA approval would be expected to help lead to reimbursement from Medicare and other insurance payors
Why it matters: An FDA approval would unlock Medicare reimbursement for Galleri, transforming Grail from a lab-based diagnostic into a broadly covered screening tool. The 33% stock surge shows investors are betting Wednesday's advisory committee panel will recommend approval, though the FDA isn't bound by committee advice.
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