FDA Decisions Loom for MRK, MIRM, GRAL, INCY in Key Regulatory Catalyst Week

Four major pharmaceutical companies, Merck (MRK), Mirum Pharmaceuticals (MIRM), Grail (GRAL), and Incyte (INCY), are waiting for key FDA decisions this week.

Merk's Winrevair is up for an expanded use in treating pulmonary arterial hypertension. An FDA decision on the updated U.S. label for Winrevair, which is based on its Phase 3 Hyperion study, is expected by September 21st.

Mirum faces a September 26th PDUFA date for Zilurgisertib, an oral drug under Priority Review for patients aged 12 and older with Fibrodysplasia Ossificans Progressiva (FOP). FOP is a rare genetic disease that causes abnormal bone formation in muscles, tendons, and other soft tissues.

Grail's Galleri blood test will be reviewed by an FDA advisory committee on Wednesday. The test screens for signals associated with more than 50 types of cancer before symptoms appear.