Dyne Therapeutics, Inc.
z-basivarsen
myotonic dystrophy type 1
Countdown
450days
Approval decision Β· ~ Sep 30, 2027 estimated
What's at stake
A final FDA approval decision on z-basivarsen for myotonic dystrophy type 1 is expected ~ Sep 30, 2027.
Primary source
Β· SEC 8-K
verified 12h ago
βexpect a potential U.S. launch of z-basivarsen in Q1 2028, assuming FDA grants Priority Review and approval is received on the anticipated timeline.β