FDA Action Alert: Upcoming Decisions on Sanofi/Regeneron, Merck, REGENXBIO and More in February 2026

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REGENXBIO expects FDA decision by Feb. 8 on RGX-121 gene therapy for Hunter syndrome, delayed from Nov. 9 to review long-term data1.

Merck seeks Keytruda label expansion for platinum-resistant recurrent ovarian cancer with chemo, ± Avastin; decision by Feb. 20, supported by KEYNOTE-B96 showing 30% PFS improvement1.

Sanofi/Regeneron propose Dupixent for allergic fungal rhinosinusitis (AFRS); decision by Feb. 28, backed by LIBERTY-AFRS-AIMS showing 50% improvement in nasal congestion vs. placebo1.

Vanda awaits Feb. 21 decision for Bysanti (milsaperidone) in acute bipolar I disorder and schizophrenia, leveraging Fanapt data1.

BioMarin targets Feb. 28 decision to expand Palynziq to adolescents (12-17 years) with PKU1.

Sources:

1. https://www.biospace.com/fda/fda-action-alert-sanofi-regeneron-merck-regenxbio-and-more