SK Biopharmaceuticals seeks FDA approval for Xcopri in primary generalized tonic-clonic seizures

PUBT · 1d ago
SK Biopharmaceuticals seeks FDA approval for Xcopri in primary generalized tonic-clonic seizures
  • SK Biopharmaceuticals filed for FDA approval of Xcopri for primary generalized tonic-clonic seizures on Nov. 3, 2026.
  • The application seeks to expand cenobamate’s use to this indication in patients aged 12 and older.
  • A 169-patient trial showed median seizure frequency reductions of 71.9% with cenobamate versus 39.6% with placebo (p=0.003).


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. SK Biopharmaceuticals Co. Ltd. published the original content used to generate this news brief via DART, the regulatory disclosure system operated by the South Korea Financial Supervisory Service (FSS) (Ref. ID: 20261104800110), on November 04, 2026, and is solely responsible for the information contained therein.