Ofman Joshua J. sold $425K of GRAL

Biopharma roundup reported FDA/EC approvals and trial updates for Lantheus (LNTH) TAUKLARIFY, Ceribell (CBLL) AI EEG algorithms, Labcorp (LH) PGDx CDx, and EU/UK approvals for Galderma (GDERF) Restylane Shaype and Rhythm (RYTM) IMCIVREE. GRAIL (GRAL) faces an FDA panel on Sept. 23. Teledyne (TDY) to buy Varex (VREX) for about $1.1B; Aura (AURA) cut 20% staff.

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. 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 Revenue are up 42% and 30% Year-Over-Year, Respectively,

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.