Grail Stock Jumps in August as FDA Schedules a Key Meeting for its Galleri Cancer Test

Multi-cancer early detection test company Grail (NASDAQ: GRAL) stock rose 15.8% in August, according to data from S&P Global Market Intelligence. However, the move was anything but linear. Instead, it was a tale of two halves: a decline in the first half of the month, followed by a strong reversal in the second, driven by pivotal regulatory news.

Grail in 2026

Grail's main aim is to convince medical insurers that its MCED test, Galleri, deserves adoption on a cost-benefit basis. In other words, will it detect cancers early enough to improve patient outcomes and enable less costly, less invasive treatments? It's not an easy calculation to make, as insurers need to factor in considerations such as the cost of confirmation testing for those patients that Galleri detects cancer in but do not turn out to have cancer.

The healthcare stock's case wasn't helped by the failure to meet the primary endpoint of a statistically meaningful reduction in the incidence of combined late-stage (Stage III + IV) cancers in more than 50 cancer types tested in a 3-year 142,000-person population trial with England's National Health Service.

The case for investing in Grail

The announcement of the trial's results led to a crash in the share price, from which it spent most of 2026 recovering, as management emphasized the "favorable trend toward fewer Stage III-IV cancers in a pre-specified group of 12 deadly cancers" from the trial.

The case for the stock rests on the eventual adoption by insurers. Food and Drug Administration (FDA) approval is seen as "the gate that a lot of payers have been waiting for to really dig into Galleri and serious conversations," according to Chief Growth Officer Andrew Partridge on the recent second quarter earnings call.

Image source: Getty Images.

What happened in August for Grail

The month started with the release of its second-quarter earnings, which showed Galleri test volume (available on an out-of-pocket basis) grew 35% year over year to more than 61,000. However, investors were concerned about the $110 million net loss and $82 million cash burn.

However, only a couple of days later, Grail announced that the FDA will meet on Sep.23 to discuss the pre-market approval application made for Galleri. While a decision won't be made on that date, it is a pivotal part of the process, and Grail's management expects approval in early 2027. That would be a major step forward in opening up conversations with insurers over Galleri.

Lee Samaha has no position in any of the stocks mentioned. The Motley Fool recommends Grail. The Motley Fool has a disclosure policy.