Praxis Precision Medicines Inc.
06/22/2026 | Press release | Distributed by Public on 06/22/2026 14:43
Material Event (Form 8-K)
Item 8.01. Other Events.
On June 22, 2026, Praxis Precision Medicines, Inc. announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation ("BTD") for elsunersen (PRAX-222), an antisense oligonucleotide for the treatment of seizures associated with SCN2A Developmental and Epileptic Encephalopathy ("DEE") caused by Gain of Function variants in SCN2A. The BTD enables expedited development and regulatory review for drugs that are intended to treat a serious condition, where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over existing therapies. The BTD for elsunersen was supported by positive topline results from the EMBRAVE Part A trial, a randomized, sham-controlled Phase 1/2 study evaluating ascending doses of elsunersen in nine pediatric patients aged 2-12 years with early-seizure-onset SCN2A-DEE.
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