Xenon announces positive FDA EOP2 meeting for XEN1101; Phase 3 to start H2 2022

Xenon Pharmaceuticals Inc.

FDA aligned on key Phase 3 elements; NDA submission planned after completion of X-TOLE2 trial plus existing Phase 2b data.
XEN1101 Phase 3 program in focal onset seizures to begin second half 2022.
Plans to initiate single Phase 3 trial (X-ACKT) for primary generalized tonic clonic seizures.
Phase 2b X-TOLE met primary endpoint with p<0.001 across all doses; drug was well tolerated.
Xenon expects differentiated profile based on Kv7 potassium channel mechanism and once-daily no-titration dosing.

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