GRAIL INC. DL-,01 Aktie

On September 21 the FDA published a positive assessment report on the multi-cancer early detection test Galleri, and an independent expert panel on September 24 voted largely in favor of approval. The news sparked a roughly 34% one-day rise in GRAIL’s stock. Despite a quarterly loss of about $110 million on $44.7 million in revenue, the company has more than $860 million in cash and is targeting a market launch in 2027. » Altro su finanzen.net

At the Morgan Stanley Healthcare Conference, GRAIL said that clinical evidence, FDA approval and reimbursement together are prerequisites for broad commercial adoption of the Galleri blood test. Test volume recently rose 35% year‑over‑year; the company reports a positive predictive value of over 60%, specificity of over 99.5% and an accuracy of signal‑origin determination of over 90%. The PMA submission relies on PATHFINDER‑2 and NHS data; FDA approval is expected to ease discussions with payers and an NCD with CMS. GRAIL highlights operational improvements (integration with Epic/athenahealth, partnership with Quest) and international expansion plans, but sees reimbursement as the "end goal" for broad market access. » Altro su de.investing.com

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