GRAIL Reports 2025 Revenue Growth and Completes PMA Submission, Yet Core Risks Persist

What happened

GRAIL announced its 2025 financial results, reporting the sale of over 185,000 Galleri tests and a 26% year-over-year increase in U.S. Galleri revenue to $136.8 million. The company completed its PMA submission to the FDA, a critical step toward potential approval, and shared topline results from the NHS-Galleri trial while finishing analysis of the PATHFINDER 2 study. However, despite this progress, GRAIL remains deeply unprofitable, with operating losses exceeding revenue in recent quarters, as highlighted in its SEC filings. The claim of cash into 2030 provides a liquidity buffer, but this must be weighed against ongoing cash burn and the binary nature of regulatory and reimbursement outcomes. Overall, the news reflects incremental execution but does not alter the fundamental challenges of scaling profitably in a competitive, uncertain market.

Implication

The 26% revenue growth and over 185,000 tests sold in 2025 demonstrate commercial traction for Galleri, supporting the multi-cancer early detection narrative. Completing the PMA submission reduces near-term regulatory uncertainty and could accelerate adoption if approved, aligning with GRAIL's long-term strategy. However, the company's operating losses remain substantial, and average selling price pressure continues to erode margins, as noted in quarterly reports. The strong cash position into 2030 offers downside protection, but liquidity depends on managing burn rates amidst high execution risks. Consequently, the implications reinforce a wait-and-see approach, with the stock's fate hinging on FDA decisions and reimbursement wins not yet secured.

Thesis delta

The completion of the PMA submission and positive clinical trial updates are incremental positives that slightly de-risk the regulatory pathway. However, without FDA approval or new payer coverage, the core thesis remains balanced on binary outcomes, sustaining the HOLD rating from the master report. Investors should monitor for concrete progress on reimbursement and approval timelines before considering a shift in stance.