GRAL Investment Deadline: GRAIL, Inc. Securities Fraud Class Action Focuses on Trial Results; Investors Notified of August 4 Court Deadline

GRAIL, Inc. (GRAL) filed an SEC Form 8-K — Results of Operations and Financial Condition. EX-99.1 2 ex9912026q2earningspressre.htm EX-99.1 Document NEWS RELEASE Exhibit 99.1 GRAIL Reports Second Quarter 2026 Financial Results Q2 Galleri ® Test Volume Increased 35% to More Than 61,000 Year-Over-Year, and Galleri Revenue Grew 24% to $42.6 Million Galleri Test Volume and

Grail (NASDAQ: GRAL) shares fell after its February NHS England Galleri trial failed to meet the primary endpoint, though it reported fewer Stage IV cancers and some earlier detections. Galleri is not FDA-approved; it’s sold cash-only at $749–$949. Revenue rose from $93M (2023) to $147M (2025) while net loss narrowed. Full-year revenue is forecast to rise 22%–32%.

Grail’s (GRAL) shares fell about 16% by midday after investors digested the company’s ASCO presentation on its Galleri multi-cancer early detection test with England’s NHS. The trial missed its primary endpoint for reducing later-stage cancers, though management cited clinically meaningful Stage IV reductions. Data showed 69.8% episode sensitivity for 12 key cancers but 39.3% for all cancers.

GRAIL (NASDAQ:GRAL) reported new Galleri multi-cancer blood test data at ASCO, including NHS-Galleri and PATHFINDER 2 results. In NHS-Galleri (142,000+ participants), the primary endpoint—reducing combined stage 3/4 incidence after three rounds—was not met, but stage 4 fell >20% in incident rounds. Galleri increased screen-detected cancers ~4x; PATHFINDER 2 (36,000+) showed PPV 60.3%, specificity 99.6%, and mostly non-invasive diagnostics.

Grail’s (GRAL) shares are down over 20% in 2026 after its three-year, 142,000-person NHS Galleri trial missed its primary endpoint, which targeted a combined reduction in Stage III and Stage IV cancer detections. CEO Bob Ragusa said Stage IV diagnoses fell. Grail reported Q1 2026 Galleri revenue up 37% YoY and volumes up 50% to 56,000. Management plans follow-up results in 6–12 months and detailed data at the ASCO meeting in late May/early June.

Jazz Pharmaceuticals said it will seek FDA removal of the second-line indication for lurbinectedin (Zepzelca) in metastatic small-cell lung cancer. Jazz plans a labeling supplement submission in Q3 2026. The indication was accelerated in 2020. The phase 3 LAGOON trial failed its overall survival endpoint, with median OS 8.7 vs 10.7 months (HR 1.19) for monotherapy. First-line maintenance remains unchanged.