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>>> Axsome's (AXSM) Stock Up Despite FDA Delay on Depression Drug


Zacks Equity Research

August 24, 2021


https://finance.yahoo.com/news/axsomes-axsm-stock-despite-fda-153703405.html


Axsome Therapeutics, Inc. AXSM announced that the FDA has extended the review period for new drug application (“NDA”) for AXS-05 as a potential treatment of major depressive disorder (“MDD”). The new PDUFA target action date is yet to be informed by FDA. The FDA, however, did not ask for any additional information from the company.

We remind investors that in July, the FDA notified the company that it has identified deficiencies within the NDA that preclude labeling discussions at the time. Axsome has announced on second-quarter earnings call that the negative development may result in a potential delay in approval of the candidate. The latest announcement by the company that the FDA is deferring its decision on the NDA did not come as a surprise for the investment community, as a delay was expected.

Despite the FDA delaying its decision on the NDA, Axsome’s shares surged 14.9% on Aug 23, as it did not request any additional information and is continuing to review the NDA. Yet, the stock has declined 69.6% so far this year against the industry’s 1.2% increase.

MDD is characterized by bad mood, inability to feel pleasure, feelings of guilt and worthlessness, low energy along with other emotional and physical symptoms. In severe cases, the indication can result in suicide. Per the National Institutes of Health, an estimated 19 million adults in the United States experience MDD each year.

If the FDA approves AXS-05 forMDD, it would be Axsome’s first commercial product. 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”).

The company is currently enrolling patients in the phase III ACCORD study evaluating the safety and efficacy of AXS-05 for treating agitation associated with AD. Completion of the study is anticipated in fourth-quarter 2022.

Axsome completed a phase II study, MERIT, evaluating AXS-05 for TRD in second-quarter 2021. The study met both primary and key secondary endpoints. Data from this study showed that AXS-05 led to substantial and significant delay in the time to relapse of depression (primary endpoint) compared to placebo. AXS-05 also significantly prevented the relapse of depression (key secondary endpoint) for at least six months compared to placebo.

Apart from AXS-05, Axsome’s key pipeline candidates include AXS-07, AXS-12 and AXS-14, which are currently being developed for multiple central nervous system indications.

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

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