Back to top

Image: Bigstock

Axsome (AXSM) Plans NDA Filing for Fibromyalgia Drug in 2022

Read MoreHide Full Article

Axsome Therapeutics, Inc. (AXSM - Free Report) announced that it plans to submit a new drug application (NDA) for its pipeline candidate, AXS-14, in the fourth quarter of 2022. The NDA will seek approval for the candidate as a potential treatment for management of fibromyalgia, a debilitating central nervous system disorder with limited treatment options. The decision was taken by the company following a successful pre-NDA meeting with the FDA. The NDA submission will take place following successful completion of manufacturing and other activities related to the product candidate.

The planned NDA will include data from successfully completed phase III and phase II studies. Data from the late- and mid-stage studies showed that treatment with AXS-14 led to statistically significant improvements compared to placebo in the weekly mean pain score in fibromyalgia patients.

Shares of Axsome have plunged 17.5% so far this year against the industry’s increase of 0.8%.

Zacks Investment ResearchImage Source: Zacks Investment Research

Apart from AXS-14, the company has several other candidates in its pipeline with one candidate under review with the FDA.

An NDA seeking approval for AXS-05 as a potential treatment of major depression disorder is under review with the FDA. A decision is expected by Aug 22, 2021. The company is making preparations to launch AXS-05, following a potential FDA approval. The candidate is being developed for treating treatment-resistant depression, smoking cessation and agitation associated with Alzheimer's disease.

Axsome’s another lead candidate, AXS-07, is being developed for the acute treatment of migraine. The NDA for AXS-07 for the acute treatment of migraine is expected to be filed by the end of the second quarter of 2021. A phase III study on AXS-12 for narcolepsy is expected to begin in the third quarter of 2021.

Zacks Rank & Stocks to Consider

Axsome currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector include Adaptive Biotechnologies Corporation (ADPT - Free Report) , Repligen Corporation (RGEN - Free Report) and BioNTech SE (BNTX - Free Report) . While BioNTech sports a Zacks Rank #1 (Strong Buy), Adaptive and Repligen carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Adaptive’s loss per share estimates have narrowed from $1.79 to $1.55 for 2021 over the past 60 days. The company delivered an earnings surprise of 9.04%, on average, in the last four quarters.

Repligen’s earnings estimates have been revised upward from $1.91 to $2.26 for 2021 over the past 60 days. The company delivered an earnings surprise of 58.14%, on average, in the last four quarters.

BioNTech’s earnings per share estimates have increased from $17.88 to $30.85 for 2021 over the past 60 days. The company delivered an earnings surprise of 22.74%, on average, in the last four quarters.

Zacks' Top Picks to Cash in on Artificial Intelligence

In 2021, this world-changing technology is projected to generate $327.5 billion in revenue. Now Shark Tank star and billionaire investor Mark Cuban says AI will create "the world's first trillionaires." Zacks' urgent special report reveals 3 AI picks investors need to know about today.

See 3 Artificial Intelligence Stocks With Extreme Upside Potential>>