GRAL Stock: Cancer Detection Firm Targets Further Upside After 381% Rally

GRAIL [GRAL] is a biotechnology company creating early cancer detection solutions.

Its flagship Galleri blood test has been commercially available in the US since 2021, but it is not considered a diagnostic test and has not been approved by the US Food and Drug Administration (FDA).

GRAIL was spun off by Illumina [ILMN] in June 2024. Investors have latched onto its high-growth cancer diagnostic story, pushing GRAL stock up about 381% year-to-date as of December 17, while international expansion through a partnership with South Korea’s Samsung [SSNLF] further boosted sentiment.

Looking ahead, 2026 could be a turning point as GRAIL expects to publish the final results from its UK Galleri trials run with the National Health Service (NHS), which will be submitted to the US FDA for approval.

Recent Developments: Positive Test Results and Strategic Collaborations

In 2025, GRAIL reached several key milestones across both clinical progress and commercial expansion.

In October, the company published results from its PATHFINDER 2 trial, showing a seven-fold increase in cancer detection for breast, cervical, colorectal and lung cancers among 35,878 participants in the US and Canada.

Results of another trial study called SYMPLIFY, which enrolled 6,238 patients aged 18 or older in the UK, showed that one-third of participants initially believed to have a false positive result were later diagnosed with cancer during follow-up within 24 months of the Galleri test trial.

GRAIL has also forged strategic partnerships to broaden access to Galleri.

In February, GRAIL teamed up with Quest Diagnostics [DGX], giving more than 500,000 healthcare providers access to simplified physician ordering and patient blood collection. A similar partnership was signed in May with healthcare software firm athenahealth to allow over 160,000 US clinicians using its network to seamlessly order Galleri blood tests.

International expansion came in the form of a collaboration with Samsung C&T and Samsung Electronics.

Samsung C&T will commercialize Galleri in South Korea, with potential expansion into Japan and Singapore, while Samsung Electronics will explore strategic collaborations including clinical research support and health data integration.

The two companies also made a $110m equity investment in GRAIL at a price of $70.05 per share of common stock.

Around the same time, Galleri was introduced in Canada in collaboration with insurer Manulife Canada [MFC:TO], marking the test’s first availability outside the US.

On the financial front, GRAIL strengthened its balance sheet in October via a $325m raise through a private placement at a price of $70.05 per share. The Menlo Park, California-based company said proceeds will allow it to fund planned operations until 2030.

GRAL Share Price: GRAIL Hits All-time High in November

GRAIL has rewarded investors by more than quadrupling its value from $17.82 at the start of 2025 to $85.87, as of December 17.

The stock enjoyed its highest gains of the year on February 13 after announcing the Galleri distribution deal with Quest Diagnostics. September saw GRAL stock gain 80% in anticipation of announcements related to Galleri trails. 

Positive trial results, the Samsung deal and better-than-expected quarterly results pushed GRAL stock to an all-time high of $115.76 on November 25.

Profit-taking in December saw GRAL drop over 22% during the month, as of December 17.

At the time of writing, GRAL’s year-to-date gains stood at 381%, comfortably outperforming former parent Illumina (-3.0%), benchmark index S&P 500 (+14.3%) and sectoral gauge S&P Biotechnology Select Industry Index [SPSIBI] (+34%).

Key Fundamentals and Financial Health: Healthy Cash Position, Increasing Top-line and No Debt

In the first nine months (9M) of 2025, GRAIL posted a 18.6% year-over-year increase in total revenue to $103.57m.

Net loss for the period narrowed to $309.17m from $1.93bn a year ago due to lower goodwill and intangible assets impairment expenses.

Total research and development expenses fell 46% year-over-year to $148.90m in 9M 2025, mainly due to workforce reductions that cut about 25% of the company’s staff in 2024.

The completion of private placement in October took GRAIL’s cash position to over $850m.

GRAIL was debt-free at the end of Q3 2025.

Biotech Rivals: Comparing GRAIL [GRAL], Caris Life Sciences [CAI] and Guardant Health [GH]

Source: Yahoo Finance, as of December 17 close.

GRAL Stock: The Investment Case

The Bull Case for GRAIL: FDA approval in 2026

The bull case rests on GRAIL’s first-mover advantage in a potentially transformative healthcare market. According to the company, Galleri blood tests could reduce cancer diagnostic costs by 65%, translating into annual savings of roughly $26bn for US patients.

GRAIL also notes that 74% of stage 1 and stage 2 cancers currently lack established screening options, opening up a sizeable and largely untapped addressable market.

The company plans to submit a premarket approval application to the FDA in 2026, following completion of the NHS-Galleri trial. If approved, Galleri could be integrated into the US healthcare system and covered by medical insurance programs.

The Bear Case for GRAIL: Galleri Test is Not Foolproof

Galleri is commercially available but has not received FDA approval, so it is not classified as a diagnostic test.

GRAIL notes that false positive and false negative results can occur. According to the company, “no cancer signal detected” result does not rule out cancer, while a positive signal must be verified through standard diagnostic procedures.

At up to $949 per test, the high out-of-pocket cost could also limit widespread adoption.

Conclusion

Final results from the NHS-Galleri trial and a planned FDA submission will determine whether Galleri transitions from a commercial screening tool to an approved, reimbursed cancer diagnostic in the US.

With ample cash and growing clinical evidence, 2026 is likely to be the inflection point that shapes GRAIL’s long-term trajectory.