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Axsome's (AXSM) Stock Up Despite FDA Delay on Depression Drug
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Axsome Therapeutics, Inc. (AXSM - Free Report) 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.
Image Source: Zacks Investment Research
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.
Horizon’s earnings per share estimates for 2021 have increased from $3.62 to $4.46 in the past 30 days. The same for 2022 has risen from $5.18 to $5.84 over the same period. The stock has rallied 47.6% in the year so far.
Regeneron’s earnings per share estimates for 2021 have increased from $49.96 to $54.15 in the past 30 days. The same for 2022 has risen from $40.91 to $44.11 over the same period. The stock has rallied 38.1% in the year so far.
Repligen’s earnings per share estimates for 2021 have increased from $2.26 to $2.76 in the past 30 days. The same for 2022 has risen from $2.57 to $3.02 over the same period. The stock has rallied 38.9% in the year so far.
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Axsome's (AXSM) Stock Up Despite FDA Delay on Depression Drug
Axsome Therapeutics, Inc. (AXSM - Free Report) 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.
Image Source: Zacks Investment Research
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 Therapeutics, Inc. Price
Axsome Therapeutics, Inc. price | Axsome Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Axsome currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the same sector are Horizon Therapeutics , Regeneron Pharmaceuticals (REGN - Free Report) and Repligen Corporation (RGEN - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Horizon’s earnings per share estimates for 2021 have increased from $3.62 to $4.46 in the past 30 days. The same for 2022 has risen from $5.18 to $5.84 over the same period. The stock has rallied 47.6% in the year so far.
Regeneron’s earnings per share estimates for 2021 have increased from $49.96 to $54.15 in the past 30 days. The same for 2022 has risen from $40.91 to $44.11 over the same period. The stock has rallied 38.1% in the year so far.
Repligen’s earnings per share estimates for 2021 have increased from $2.26 to $2.76 in the past 30 days. The same for 2022 has risen from $2.57 to $3.02 over the same period. The stock has rallied 38.9% in the year so far.