HAGENS BERMAN, SOBOL SHAPIRO LLP ALERT: GRAIL, Inc. (NASDAQ: GRAL) Investors Urged to Contact Hagens Berman; Securities Fraud Class Action Filed, August 4, 2026 Lead Plaintiff Deadline

GRAIL said the FDA Molecular and Clinical Genetics Panel will meet Sept. 23, 2026 to review its Premarket Approval application for Galleri, a multi-cancer early detection blood test. The submission cites PATHFINDER 2 (25,490 participants, one year) and NHS-Galleri (over 70,000). GRAIL says Galleri detects methylation patterns, with low false positives and accurate signal origin prediction.

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

Bleichmar Fonti & Auld LLP says a securities fraud class action was filed against GRAIL, Inc. (NASDAQ:GRAL) and executives after the company’s NHS-Galleri trial allegedly failed to support prior statements. The suit cites a ~50.55% stock drop (Feb. 19–20, 2026) and alleges violations of Exchange Act Sections 10(b) and 20(a). Investors have until Aug. 4, 2026 to seek lead-plaintiff status.

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.