Mentioned:
GRAIL is advancing one of the most ambitious new bets in cancer screening. And now, FDA staff has just given it a largely positive review ahead of a major advisory panel vote.
What’s happening:
- The United States Food and Drug Administration published staff briefing documents that show no major safety or accuracy concerns ahead of the upcoming advisory panel for GRAIL’s (NASDAQ: GRAL) Galleri premarket approval
Why it matters:
- GRAIL’s Galleri device is aiming to use a single blood draw for early cancer detection and could potentially detect more than 50 different cancer types
Going deeper:
- GRAIL has been developing their Galleri device for more than a decade and has enrolled more than 300,000 individual participants throughout multiple different studies
- The United States Food and Drug Administration’s independent advisory panel will formally vote on whether Galleri’s benefits outweigh possible risks and provide a non-binding recommendation for an approval decision
Market reaction:
- Shares of GRAIL surged more than +33% following documents from the United States Food and Drug Administration raising no major concerns about Galleri
