News summary

SK Biopharmaceuticals Submits Supplemental New Drug Application to U.S. FDA for Cenobamate

Source: PR Newswire • Published: 04 Nov 2026, 14:52

Summarized by Masters of Longevity from PR Newswire.

Company submitted sNDA after a Phase 3 trial showed efficacy in PGTC seizures.

SK Biopharmaceuticals Submits Supplemental New Drug Application to U.S. FDA for Cenobamate
Key Takeaways
  • Phase 3 found cenobamate reduced PGTC seizures versus placebo.
  • Most adverse events were mild to moderate and expected.
  • Company reported sNDAs for PGTC and pediatric focal-onset.
Read the full article at PR Newswire ↗

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