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Axsome's AXS-07 Meets Co-Primary Goals in Migraine Study

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Axsome Therapeutics, Inc. AXSM announced that its novel, oral, multi-mechanistic investigational candidate, AXS-07, met two regulatory co-primary endpoints in the phase III INTERCEPT study. The co-primary goals are freedom from migraine pain and freedom from most bothersome symptoms compared to placebo in the study.

AXS-07 substantially and significantly eliminated migraine pain and also substantially and significantly prevented progression of migraine pain intensity in the late-stage study that evaluated the candidate for early treatment of migraine.

Per the press release, when treated with AXS-07, 33% patients achieved freedom from migraine pain compared to 16% subjects who received placebo after two hours of dosing. Prevented progression of migraine pain beyond mild intensity was experienced by 74% of AXS-07 patients compared to 47% of placebo within two to 24 hours of treatment.

Per the company, this randomized, double-blind, placebo-controlled INTERCEPT study enrolled 302 patients who were randomized in a 1:1 ratio to treat a single migraine attack with a single dose of AXS-07 (20 mg MoSEIC meloxicam/10 mg rizatriptan) or placebo at the earliest sign of migraine pain when the pain intensity was mild.

AXS-07 substantially and significantly lowered functional disability while also demonstrating overall disease improvement. Treatment with AXS-07 led to 73.5% of patients performing normal activities at 24 hours compared to 47.4% of patients who received placebo.

Shares of Axsome have plunged 48.2% so far this year compared with the industry’s decrease of 11.61%.

 

We remind investors that in December 2019, AXS-07 met the two regulatory co-primary endpoints in the phase III MOMENTUM study evaluating the same for acute treatment of migraine.

Notably, the MOMENTUM study enrolled patients only with a history of inadequate response to prior acute treatments, while the INTERCEPT study, recruited all comers in which patients received AXS-07 at the initial stage of migraine pain when the pain was mild, before it got moderate or severe.

Axsome plans to file a new drug application for AXS-07 to the FDA in the fourth quarter of 2020 to treat acute migraine. The successful development and commercialization of the candidate will lend a significant boost to Axsome.

Zacks Rank & Stocks to Consider

Axsome currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Acorda Therapeutics, Inc. ACOR, Abeona Therapeutics Inc. ABEO and Celldex Therapeutics, Inc. CLDX, all sporting a Zacks Rank #1 (Strong Buy).

You can see the complete list of today’s Zacks #1 Rank stocks here.

Acorda’s loss per share estimates have been narrowed 8.8% for 2020 and 11.1% for 2021 over the past 60 days.

Abeona’s loss per share estimates have been narrowed 21.5% for 2020 and 16.8% for 2021 over the past 60 days.

Celldex’s loss per share estimates have been narrowed 12.5% for 2020 and 12.8% for 2021 over the past 60 days.

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