Axsome (AXSM) Plans NDA Filing for Fibromyalgia Drug in 2022
Zacks Investment Research | Jun 16, 2021 08:00AM ET
Axsome Therapeutics (NASDAQ:AXSM), Inc. industry ’s increase of 0.8%.
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.
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