Grail (GRAL) 股价在 FDA 顾问委员会对 Galleri 检测给出积极意见后飙升 36%

Core Points

The FDA Advisory Committee voted 7 - 2 that the benefits of Grail's Galleri test outweigh the potential risks. The safety assessment was unanimously approved (10-0), while the effectiveness assessment was supported by the expert group with a 6 - 4 vote.

Grail shares have surged 36% in the past week to about $108 a share. Canaccord Genuity maintained its "Buy" rating after the hearing and raised its price target. Full FDA approval is expected to be granted in the coming months.

Grail (GRAL) shares rose 36% due to the FDA advisory team's positive vote on the Galleri test.

Earlier this week, the FDA advisory team gave a key endorsement of its Galleri multi-cancer blood screening technology, and Grail (GRAL) shares currently hover around $108. The stock has risen 36% in the past week, with most of the gains coming in the two trading days leading up to Wednesday's group meeting.

On Wednesday, the Molecular and Clinical Genetic Devices Group met to evaluate Galleri. Panelists voted 7 - 2 (with one abstention) to support the conclusion that the benefits of the diagnostic tool outweigh the potential disadvantages.

The safety evaluation received a unanimous vote of 10-0. The validity determination was more controversial and was ultimately passed with a 6 - 4 vote.

During the panel's deliberations, Grail shares were suspended throughout the trading session. The stock has already experienced a sharp rise after positive briefing materials were released online on Monday.

Although full FDA authorization is not 100 per cent certain, given the outcome of the hearing, the possibility seems high. Industry analysts expect to make regulatory decisions in the coming months.

Understanding the function of Galleri

Galleri detects DNA fragments that carry the characteristics of cancer cells by analyzing blood samples. The test can identify whether cancer signals are present in the body and provide an estimate of the source of the signal.

Clinical studies have shown that Galleri is able to identify malignancies that lack conventional screening methods, such as ovarian and pancreatic cancer. The technique produces false positives at a low frequency, but when cancer actually exists, its detection rate is about 50%.

This detection performance is superior to existing tools such as mammography. Grail envisions patients using Galleri in conjunction with the current single cancer screening regimen, rather than as a replacement.

However, one clinical trial brought complications. The NHS-Galleri study in the UK failed to demonstrate that screening reduced the number of stage IV cancers diagnosed a year later. Several panellists suggested that this deficiency created uncertainty as to whether Galleri would extend life. It is worth noting that many of the currently widely used screening techniques, such as colonoscopy, were accepted before evidence of long-term survival validated their effectiveness.

Revenue Projections and Expert Comments

Grail currently charges US$950 per Galleri test, although insurance reimbursement remains uncommon. The company recorded revenue of about $150 million last year and expects revenue to reach $180 million this year.

Mizuho analyst Bradley Bowers expects a larger increase in revenue after receiving regulatory approval. He cited similar cancer screening products, including Cologuard and Guardant Health's Shield Diagnostics, which have doubled revenue during their respective launches.

Legislative action has mandating Medicare to evaluate the coverage of diagnostic tools such as Galleri after FDA authorization. UBS analyst Doug Schenkel predicts that Medicare reimbursement starting in 2029 could contribute approximately $300 million to Grail's annual revenue next year, bringing total sales closer to the $1 billion mark.

Canaccord Genuity reiterated its "buy" stance on Grail on Wednesday and described the hearing as exceeding expectations. The company believes that the team's benefit-risk vote is a strong indicator of eventual authorization.

Grail's current market value is US$4.3 billion, which is equivalent to about 19 times expected revenue next year. This valuation already includes expectations for a high probability of approval.

Investment Perspective

InvestingPro data shows that the stock is trading at a price higher than the fair value calculated by the platform, and RSI measurements indicate it is in overbought territory after the recent rebound. Grail is not expected to be profitable this year.

In its latest quarterly report, Grail disclosed revenue of $44.7 million, exceeding analyst consensus expectations of $43.2 million, while also earning a loss per share of $2.56. Canaccord will host a webinar on Friday, inviting two cancer screening experts to analyze the team's conclusions and discuss upcoming developments.