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Axsome's (AXSM) Migraine Drug AXS-07 NDA Gets FDA Acceptance

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Axsome Therapeutics, Inc. AXSM announced that the FDA has accepted its new drug application (NDA) for its novel, oral, multi-mechanistic investigational candidate, AXS-07. The NDA is seeking approval of AXS-07 as a potential acute treatment of migraine. The FDA is expected to decide on AXS-07’s NDA by Apr 30, 2022.

The NDA was based on data from two phase III studies that demonstrated that treatment with the candidate achieved statistically significant elimination of migraine pain compared to placebo. Data from a long-term phase III study, announced in January, showed that 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.

Shares of Axsome have plunged 67.9% so far this year compared with the industry’s decrease of 0.9%.

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Meanwhile, the company’s NDA for its another candidate, AXS-05, is already under review with the FDA. The NDA is seeking approval of the candidate as a potential treatment of major depressive disorder. However, the FDA extended the review period for the NDA last month and is yet to provide a definite date to announce its decision. Although the FDA did not ask for any additional information, it had notified the company in July about deficiencies within the NDA that preclude labeling discussions.

Axsome is also developing AXS-05 as a potential remedy for treatment-resistant depression (“TRD”), smoking cessation, and agitation associated with Alzheimer's disease (“AD”). Top-line data from the phase III study evaluating the candidate in AD patients is expected in the fourth quarter of 2021.

Recently, the company completed a phase II study on AXS-05 in TRD . Data from this study showed that AXS-05 led to a substantial and significant delay in the time to relapse of depression compared to placebo.

Axsome’s other pipeline candidates include AXS-12 and AXS-14, which are currently being developed for multiple central nervous system indications. However, the FDA rescinded its Breakthrough Therapy designation for cataplexy candidate, AXS-12 in July, following the approval of Harmony Biosciences’ HRMY Wakix last year.

Axsome has an exclusive license agreement with Pfizer PFE for the latter’s non-clinical and clinical data on reboxetine, the active pharmaceutical ingredient in AXS-12.

Axsome Therapeutics, Inc. Price

Axsome Therapeutics, Inc. Price
Axsome Therapeutics, Inc. Price

Axsome Therapeutics, Inc. price | Axsome Therapeutics, Inc. Quote

Zacks Rank & Stock to Consider

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

Vertex Pharmaceuticals Incorporated VRTX is a better-ranked company from the biotech sector, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Vertex’s earnings estimates have moved north from $11.22 to $12.37 for 2021 and from $12.24 to $13.13 for 2022 over the past 30 days.

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Pfizer Inc. (PFE) : Free Stock Analysis Report

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Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report

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