Why Investors Shouldn’t Sleep on This Narcolepsy Study

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Axsome Therapeutics Inc. (NASDAQ: AXSM) shares jumped early on Tuesday after the firm announced positive results from its midstage narcolepsy trial. Specifically, the results come from the Phase 2 Concert trial of AXS-12, which met the primary endpoint and significantly reduced the number of cataplexy attacks in patients with narcolepsy.

Narcolepsy is a debilitating, neurological condition characterized by excessive daytime sleepiness and cataplexy, a sudden loss of muscle tone triggered by strong emotions.

Concert was a Phase 2 trial in which 21 patients with a diagnosis of narcolepsy with cataplexy were all treated with orally administered AXS-12 for two weeks and with placebo for two weeks. The treatment periods were separated by one week of down-titration and washout.

Overall, the study also demonstrated that AXS-12 significantly reduced excessive daytime sleepiness and improved cognitive function, sleep quality and sleep-related symptoms.

AXS-12 met the primary endpoint by demonstrating a highly statistically significant reduction from baseline in the mean weekly number of cataplexy attacks, averaged for the two-week treatment period (overall treatment effect), as compared to placebo. At Week 2, AXS-12 demonstrated a mean reduction of 14.6 cataplexy attacks per week, compared to a reduction of 2.6 attacks per week for placebo, representing mean reductions of 48.8% and 8.6% from baseline, respectively. The proportion of patients achieving a 50% or greater reduction in the weekly number of cataplexy attacks was 76.2% for AXS-12, compared to 30.0% for placebo at Week 2. The improvement in cataplexy was rapid with AXS-12 demonstrating significant benefit over placebo as early as Week 1.

Previously, AXS-12 was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy.

Shares of Axsome Therapeutics traded up around 14% to $45.21 early Tuesday, breakout out of the prior 52-week range of $1.94 to $40.52. The consensus price target is just $39.86.


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