FDA gave us a path forward. finally.

Company: Sarepta Therapeutics

Posted by SareptaRep_NewEngland_2245 · March 19, 2026

Tags: launch, strategy, field

after the ESSENCE miss and months of uncertainty — FDA confirmed we can submit using 9-year data plus real world evidence.

they're not pulling the approvals.

spent Q4 having really hard conversations.

this is the first good news in a while.

not guaranteed but having a path matters.

13 upvotes · 5 comments