Healthcare Business

The FDA Comes Down on Gilead and Galapagos With CRL

When it rains, it pours. BioMarin Pharma was not the only company to receive a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). Gilead Sciences Inc. (NASDAQ: GILD) and Galapagos N.V. (NASDAQ: GLPG) were victims on Wednesday after the agency came down on their rheumatoid arthritis (RA) treatment.

Specifically, the CRL is for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately to severely active RA.

The FDA has requested data from the MANTA and MANTA-RAy studies before completing its review of the NDA. The FDA also has expressed concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose.

The MANTA and MANTA-RAy studies are fully recruited, with topline results expected in the first half of 2021. Filgotinib is currently under review by regulatory authorities around the world.

Also, filgotinib recently received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, recommending marketing authorization for filgotinib in the European Union for the treatment of adults with moderate to severe RA who have responded inadequately or are intolerant of one or more disease-modifying anti-rheumatic drugs.

Management at Gilead noted that it continues to believe in the benefit/risk profile of filgotinib in RA, which has been demonstrated in the FINCH Phase 3 clinical program

Gilead stock traded down about 3% to $67.16 Wednesday morning, in a 52-week range of $60.89 to $85.97. The consensus price target is $80.17.

Galapagos stock was down 25%, at $140.80 in a 52-week range of $112.00 to $274.03. Analysts have a consensus price target of $224.31.