Regeneron Gets Speedy FDA Review of Garetosmab in FOP
By Colin Kellaher
Regeneron Pharmaceuticals has won U.S. Food and Drug Administration priority review for its application seeking approval of garetosmab for adults with the ultra-rare genetic disorder fibrodysplasia ossificans progressiva, or FOP.
Regeneron on Thursday said garetosmab, if approved, would be the first and only available treatment shown to reduce the number and volume of new heterotopic bone lesions in adults with FOP, which is characterized by abnormal bone formation that infiltrates muscles, tendons, ligaments and other connective tissues, resulting in significant disability.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.
Regeneron said the FDA has set an August target action date for the application.
The Tarrytown, N.Y., biotechnology company said it plans to start a Phase 3 study of garetosmab in adolescents and children with FOP later this year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 19, 2026 08:04 ET (13:04 GMT)
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