Grail trades near $70 after Galleri trial failure erases $2.2B
**Grail's Galleri blood test missed its primary endpoint in the NHS England trial, yet the company still generates revenue without FDA approval.**
Grail's stock trades near $70, down 50 percent from its January record of $116.06, after the Galleri trial failed its primary endpoint, erasing $2.2 billion in market value.
"We're focused on when GRAIL and its management knew that the need for a longer follow-up period diverged from the touted three-year duration," Reed Kathrein, partner at Hagens Berman Sobol Shapiro, said.
The trial aimed to demonstrate a statistically significant reduction in late-stage (Stage III and IV) cancer diagnoses. On Feb. 19, Grail announced the trial did not meet its primary endpoint, admitting it "probably should have allowed for a longer follow-up period." Shares collapsed 50.55 percent the next day, from $101.53 to $50.21 per share.
The trial was considered a crucial stepping stone toward FDA approval in the U.S., which would clear the way for private insurance and Medicare coverage. Without it, Grail sells Galleri on a cash-only basis for $749 to $949 per test, with analysts projecting revenue growth from $147 million in 2025 to $281 million in 2028.
**Trial Failure Triggers Class Action, $2.2B Wipeout**
The Feb. 19 disclosure triggered a securities fraud class action, with the lead plaintiff deadline set for Aug. 4. The lawsuit, Robbins v. Grail, Inc., No. 26-cv-05428, is pending in the U.S. District Court for the Northern District of California. It alleges Grail and senior executives misrepresented the clinical design and progress of the NHS-Galleri trial, claiming the three-year follow-up period was sufficient when internal data from the first screening round suggested otherwise.
The complaint cites a timeline of alleged misrepresentations: May 13, 2025, when Grail announced positive top-line results but withheld detailed positive predictive value numbers; Aug. 12, when the company confirmed statistical powering was sufficient; and Nov. 12, when the Q3 earnings call repeated high-PPV messaging without updated risk disclosures.
Multiple firms are soliciting investors, including Rosen Law Firm, Pomerantz LLP, Berger Montague PC, Bleichmar Fonti & Auld LLP, and Robbins Geller Rudman & Dowd LLP. Hagens Berman's investigation focuses on when management first recognized the three-year follow-up was insufficient.
**Cash-Only Model Buys Time, But FDA Approval Remains the Prize**
Despite the trial setback, Grail continues to sell Galleri directly to consumers, employers, hospital pilots, and telehealth programs. The NHS England trial wasn't a complete failure: Galleri users had fewer Stage IV cancers detected and achieved earlier detection of the deadliest cancers.
Mizuho raised its price target on Grail to $65 with a Neutral rating on July 16, while the company's Q2 2026 results are due Aug. 5. Grail also expanded access to Galleri through a partnership with Priority Health for employers announced July 16.
The company trades at 17 times this year's sales, a premium that reflects the potential of the multi-cancer early detection market. Illumina, which spun off Grail in 2024, retains a significant stake. Exact Sciences and Guardant Health are among the competitors in the liquid biopsy space, though Galleri's multi-cancer approach differs from their single-cancer or minimal residual disease tests.
Grail's cash position and revenue trajectory will be key watch items when it reports Q2 results. The company's ability to sustain its cash-only model while pursuing FDA approval will determine whether the stock can recover from the trial failure.
This article is for informational purposes only and does not constitute investment advice.