BUZZ - Broker View: Grail's Progress in Cancer Detection Boosts Multi-Cancer Screening Market Outlook

September 24 - ** Cancer detection company Grail (GRAL.O) on Wednesday received the support of an external expert advisory panel from the United States Food and Drug Administration (FDA) (link), paving the way for a potentially landmark approval of its test in the field of cancer screening.

** The expert panel, by a vote of 7 in favor, 2 against, and 1 abstention, determined that the test, called Galleri, is capable of detecting hard-to-find cancers and is therefore suitable for adults aged 50 and above.

** Since Monday, the company's share price has risen by more than 34%, following the release of an FDA staff briefing document prior to the expert panel meeting, which found no concerns regarding the test's analytical performance or safety.

Clearly positive

** Piper Sandler (rated “Neutral”) said it believes this positive vote is “a favorable development for Galleri’s regulatory pathway, though differences remain on the effectiveness and benefit-risk assessment, highlighting ongoing concerns regarding its clinical benefits.”

** The firm expects the FDA to make a decision in the first half of 2027, and considers that coverage by federal Medicare is a key threshold for achieving wide adoption.

** RBC Capital Markets (“Sector Perform,” price target: $84) said the favorable vote is clearly positive for Grail, and that Galleri’s progress will provide a boost for the entire multi-cancer detection (MCD) field.

** TD Cowen (“Buy,” price target: $88) stated that the panel’s assessment of Galleri’s safety was “outstanding,” while opinions on its effectiveness were “mixed (but somewhat positive).”

** “The advisory panel appears to support broad anti-cancer indications, which will include guideline-covered tumors such as colorectal and lung cancer (this is a surprisingly positive signal for us), although the indications include substantial explanations about lack of efficacy data, false negatives, and false positives.” — Securities firm

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