Dyne Therapeutics, Inc.
z-basivarsen
Myotonic Dystrophy Type 1 (DM1)
Countdown
542days
FDA decision · ~ Dec 31, 2027 estimated
What's at stake
The FDA's approval decision on z-basivarsen for Myotonic Dystrophy Type 1 (DM1) is due ~ Dec 31, 2027. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 13h ago
“Key Milestones for Z-Basivarsen • T opline data from the ACHIEVE REC are planned for Q1 2027 to support a potential Biologics License Application (BLA) submission for U.S. Accelerated Approval in Q3 2027.”