Just came across this - Regeneron got FDA priority review for garetosmab, their new treatment targeting FOP. Pretty interesting stuff if you follow biotech. So basically they've been working on blocking this protein called Activin A that drives the bone growth in FOP patients, and the Phase 3 trial results look solid.



The numbers are actually wild - patients on the lower dose (3 mg/kg) saw a 94% reduction in new bone lesions compared to placebo, and the higher dose hit 90%. Both showed over 99% reduction in total volume of lesions. FDA's targeting August 2026 for a decision, so we're looking at maybe a few months out.

FOP is one of those rare genetic disorders that doesn't get as much attention, so it's kind of cool seeing actual progress here. The monoclonal antibody approach seems to be working better than expected based on the trial data. Stock was down a bit when I checked, but that's typical with these announcements. Curious to see if this actually makes it through FDA approval on schedule.
This page may contain third-party content, which is provided for information purposes only (not representations/warranties) and should not be considered as an endorsement of its views by Gate, nor as financial or professional advice. See Disclaimer for details.
  • Reward
  • Comment
  • Repost
  • Share
Comment
Add a comment
Add a comment
No comments
  • Pin