Axsome's AXS-12 meets primary endpoint in ENCORE Phase 3 trial for narcolepsy with cataplexy

Axsome Therapeutics, Inc.

Primary endpoint met: AXS-12 significantly reduced cataplexy attacks vs placebo (p=0.017); placebo worsening +10.29 attacks/week vs +1.32 with AXS-12.
Improvements in cognition and overall narcolepsy: NSAQ ability to concentrate (p=0.011) and PGI-C global improvement (p=0.024) both significant.
During open-label, 72% achieved ≥50% cataplexy reduction at 1 month, 82% at 6 months; mean ESS reduced 5.6 points at 1 month, 7.3 at 6 months.
Company plans to expedite NDA filing and request pre-NDA meeting with FDA; Orphan Drug Designation grants 7-year exclusivity upon approval.

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