GRAIL Risk-Reward Attractive Ahead of FDA Advisory Committee, UBS Says

MT Newswires Live00:46

GRAIL (GRAL) has an attractive risk-reward profile ahead of the FDA's Sept. 23 advisory committee meeting on its Galleri multi-cancer detection assay, UBS said in a note.

UBS said 225 of 227 public comments submitted to the FDA as of Sept. 15 supported approval, while eight called for stricter labeling, clearer cancer-specific performance disclosures and post-market evidence.

The bank expects the FDA briefing documents to provide more clarity on the panel's focus. UBS said the safety profile from the PATHFINDER 2 study provides a strong foundation, while the NHS-Galleri trial's failure to meet its primary endpoint is a notable risk.

UBS expects FDA approval next year and said a failure to gain approval could leave the stock trading around $40 to $50 per share, while approval could result in a $150 to $170 per share valuation.

UBS reiterated a buy rating and $105 price target.

Price: 80.52, Change: +0.57, Percent Change: +0.71

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