GRAIL INC. DL-,01 Aktie

An FDA advisory panel (Molecular and Clinical Genetics Panel) will decide on 23 September on the PMA approval application for GRAIL's Galleri blood test. The test detects cancer-specific methylation patterns and is intended to complement guideline-based screening. The approval application relies on data from 25,490 participants in the PATHFINDER-2 study and more than 70,000 participants from the intervention arm of the NHS-Galleri study; Galleri was granted Breakthrough Device status in 2018. » Altro su de.investing.com

Grail missed the NHS trial's primary endpoint for reducing Stage III–IV cancers but management says 12‑month follow-up could reveal late‑stage cancers in the control arm and improve the trial's signal. A pre‑specified group of 12 deadly cancers showed a favorable trend and episode sensitivity substantially higher than overall results, while positive predictive values (52% NHS, 60.3% PATHFINDER 2) bolster the test's economic case. FDA clearance and insurer cost‑benefit analyses remain decisive for real‑world adoption and the stock's upside, leaving the situation attractive mainly to risk‑seeking investors. » Altro su finance.yahoo.com

Grail's Galleri multi-cancer early detection test showed favorable results in two major studies (NHS Galleri 2 and Pathfinder 2) presented at ASCO 2026, including reductions in late-stage diagnoses and increased early-stage detections. Grail submitted Galleri for FDA approval in January 2026 and Medicare coverage for FDA-approved MCED tests was enabled by recent legislation, which could accelerate insurer reimbursement. The company remains unprofitable and faces competition from Exact Sciences/Abbott and Guardant Health, so investor gains depend on regulatory approval and payer uptake. » Altro su finance.yahoo.com