FDA Decisions Loom Large for Merck, Mirum, and Grail This Week

The FDA has several key decisions and reviews scheduled for this week, including treatments for pulmonary arterial hypertension, a rare genetic bone disorder, and cancer detection. Merck (MRK) is awaiting an FDA decision on expanded use of Winrevair for PAH, while Mirum Pharmaceuticals (MIRM) faces a decision on Zilurgisertib for the rare bone disorder FOP. Incyte (INCY) retains an economic interest in Zilurgisertib through its licensing agreement with Mirum.

Grail's (GRAL) Galleri blood test, designed to detect signals associated with more than 50 cancers, will undergo an FDA advisory committee review. The test analyzes DNA fragments in the bloodstream for abnormal methylation patterns associated with cancer and can predict where in the body a detected cancer signal likely originated.

Merck generated $588 million in second-quarter sales from Winrevair, which is already FDA-approved for adults with PAH. The company has a broad pipeline spanning oncology, cardiovascular disease, vaccines, and infectious diseases, with $6.85 billion in cash and cash equivalents at the end of June.

Mirum paid Incyte $16 million upfront for Zilurgisertib and could potentially pay $63 million in regulatory and commercial milestones. Mirum already markets drugs to treat liver and genetic diseases, with $561.3 million in unrestricted cash, cash equivalents, and investments at the end of June.

Grail ended June with $767.6 million in cash, cash equivalents, and marketable securities. Retail sentiment on Stocktwits was 'bearish' for MRK and GRAL, 'neutral' for INCY, and 'bullish' for MIRM.