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Axsome's (AXSM) Migraine Drug Shows Long-Term Safety in Study

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Axsome Therapeutics, Inc. (AXSM - Free Report) announced positive data from a long-term phase III study evaluating its novel, oral, multi-mechanistic investigational candidate, AXS-07 for the acute treatment of migraine.

The open-label MOVEMENT study evaluated the long-term safety of AXS-07 in patients with migraine attacks who were dosed for up to 12 months. Data from the same showed that treatment with AXS-07 led to rapidly, substantially and durably relieved migraine pain and associated symptoms in the patient population. Moreover, long-term treatment with AXS-07 was generally well tolerated and the safety profile was similar to that observed in the previously reported short-term controlled studies.

Per the company, treatment with AXS-07 durably relieved migraine pain with 85% of patients remaining free from rescue medication through 24 hours. Also, 83% of patients remained rescue medication free through 48 hours after a single administration of AXS-07. Moreover, around 70% of patients achieved migraine pain relief and approximately 40% of patients achieved pain freedom at two hours following treatment with AXS-07.

Notably, patients who enrolled in the MOVEMENT study have already completed previous pivotal studies on AXS-07, namely – the MOMENTUM study which investigated AXS-07 as an acute treatment of migraine and the INTERCEPT study which evaluated AXS-07 as an early treatment of migraine.

Axsome plans to file a new drug application (“NDA”) for AXS-07 for acute treatment of migraine in the first quarter of 2021.

Shares of Axsome have plunged 13.8% in the past year against the industry’s increase of 7.1%.

price chart for AXSM


In a separate press release, the company announced that it has initiated a second pivotal phase III study on one of its lead pipeline candidates, AXS-05, for the treatment of Alzheimer’s disease (“AD”) agitation.

The double-blind, placebo-controlled ACCORD study will evaluate the safety and efficacy of AXS-05 for AD agitation, an indication for which no treatment is currently approved. Top-line data from the ACCORD study is expected in the second half of 2022.

Notably, AXS-05 is being evaluated in the pivotal phase II/III ADVANCE-1 study for treating agitation associated with AD. In June 2020, the FDA granted a Breakthrough Therapy designation to AXS-05 for the given indication.

Apart from AD agitation, AXS-05 is also being developed for treating major depressive disorder (“MDD”), treatment-resistant depression (TRD). An NDA for AXS-05 to treat MDD is expected to be filed this month.

Zacks Rank & Stocks to Consider

Axsome currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the biotech sector include Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , Blueprint Medicines Corporation (BPMC - Free Report) and Anavex Life Sciences Corp.(AVXL - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Shares of Vertex have increased 5.5% in the past year.

Shares of Blueprint Medicines have rallied 38% in the past year.

Shares of Anavex Life Sciences have skyrocketed 82.4% in the past year.

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