05/27/2026
The date is locked in for LGMD2I/R9.
The FDA has accepted our NDA for BBP-418 for LGMD2I/R9 and set a PDUFA target action date of November 27, 2026, the date by which the FDA will complete its review.
LGMD2I/R9 is a progressive, life-shortening disease with no approved treatments. If BBP-418 is approved, it would be the first for LGMD2I/R9, and potentially for any form of .
For a community that has lived with no approved treatment options, timing is everything. We're racing toward potential approval and preparing for launch so that those with LGMD2I/R9 can be reached as quickly and safely as possible.