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Demonstrated statistical significance on regulatory co-primary endpoints of pain freedom (p<0.001) and freedom from most bothersome symptom (p=0.002) at 2 hours, compared to placebo Demonstrated...
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Enrollment in MOMENTUM Phase 3 migraine trial of AXS-07 in patients with history of inadequate response nearly complete; on track for topline results in 4Q 2019 First patient dosed in new INTERCEPT...
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Topline results now anticipated in 2H 2019 Trial enriched with only patients with history of inadequate response to prior migraine treatments Trial compares AXS-07 to placebo and active comparator ...
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FDA agreement achieved on Phase 3 trial design, endpoints, and statistical approach Trial to enroll patients with a history of inadequate response to prior migraine treatments Trial initiation...
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Incorporates new molecular entity for migraine and Axsome’s MoSEIC™ technology Potential for superior efficacy as compared to current treatments FDA Pre-IND meeting written guidance received Issued...