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Axsome (AXSM) Begins Late-Stage Sleep Disorder Study on AXS-12

Axsome Therapeutics, Inc. AXSM announced that it has initiated enrollment in the phase III study — SYMPHONY — which will evaluate its pipeline candidate, AXS-12, in patients with narcolepsy, a sleep disorder. Top-line data from the study is expected in 2023.

The company has successfully completed a phase II study evaluating the candidate in narcolepsy patients. Data from the mid-stage study demonstrated that treatment with AXS-12 resulted in a highly statistically significant reduction in the mean weekly number of cataplexy attacks from baseline compared to placebo, following a treatment period of two weeks. The treatment with AXS-12 also improved excessive daytime sleepiness by reducing the frequency of inadvertent naps in patients.

The candidate enjoys Orphan Drug Designation for the treatment of narcolepsy in the United States. However, the candidate lost its Breakthrough Therapy designation in July this year. The company stated that the FDA repealed the Breakthrough Therapy designation, following its approval to another drug, most likely Harmony BiosciencesHRMY Wakix, as the first and only non-scheduled treatment for narcolepsy patients. We note that apart from Harmony Biosciences, Axsome will also face stiff competition from Jazz Pharmaceuticals JAZZ that has a strong sleep disorder portfolio with a couple of drugs approved to treat narcolepsy.

We also note that Axsome has an exclusive license agreement with Pfizer PFE for the non-clinical and clinical data on the latter’s reboxetine, the active pharmaceutical ingredient in AXS-12 that will support the potential new drug application (NDA) for the candidate.

Shares of Axsome have plunged 65% so far this year compared with the industry’s decrease of 0.1%.

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The company’s leading pipeline candidates are AXS-05 and AXS-07 for which NDAs have been filed with the FDA seeking their approval. While the company is seeking approval for AXS-05 as a treatment of major depression disorder, AXS-07’s NDA is for acute treatment of migraine. A decision from the FDA related to the approval of AXS-07 is expected by April-end in 2022. In July, the FDA notified the company that it has identified deficiencies within the NDA that preclude labeling discussions at the time and has extended the review period of the NDA for AXS-05. The new PDUFA target action date is yet to be informed by the FDA.

Axsome is also developing AXS-05 as a potential remedy for treatment-resistant depression, smoking cessation, and agitation associated with Alzheimer's disease. The company has another candidate, AXS-14, in its pipeline that is in late-stage development as a potential treatment for the management of fibromyalgia, a debilitating central nervous system disorder with limited treatment options.

Zacks Rank

Axsome currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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