Back to top

Image: Bigstock

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

Read MoreHide Full Article

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.

These Stocks Are Poised to Soar Past the Pandemic

The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.

Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.

See the 5 high-tech stocks now>>