Grail Inc (GRAL) has disclosed a new risk, in the Regulation category.
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Grail Inc faces a potential business risk due to the uncertain regulatory environment surrounding Laboratory Developed Tests (LDTs) and the FDA’s authority to regulate them as medical devices. The company has heavily invested in obtaining a Pre-Market Approval (PMA) for its Galleri test, which could enhance its market position and adoption rates. However, if the FDA cannot enforce its authority, competitors may benefit from less stringent regulations, leading to increased competition. This shift could challenge Grail Inc’s ability to adapt, potentially impacting its business and future prospects.
The average GRAL stock price target is $38.67, implying 20.17% upside potential.
To learn more about Grail Inc’s risk factors, click here.