Posted by Michael Wonder on 23 Jun 2026
Praxis Precision Medicines receives FDA breakthrough therapy designation for elsunersen for the treatment of seizures associated with SCN2A developmental and epileptic encephalopathy caused by gain of function variants
22 June 2026 - -- Praxis Precision Medicines today announced that the US FDA has granted breakthrough therapy designation for elsunersen (PRAX-222), an antisense oligonucleotide for the treatment of seizures associated with SCN2A developmental and epileptic encephalopathy caused by gain of function variants in SCN2A.
The breakthrough therapy designation was granted based on the positive results from the EMBRAVE Part A trial of elsunersen.
