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Axsome Therapeutics, Inc. (AXSM - Free Report) incurred a loss of 86 cents per share for second-quarter 2021, slightly narrower than the Zacks Consensus Estimate of a loss of 88 cents but wider than the year-ago loss of 49 cents.
Axsome currently does not have any approved product in its portfolio. As a result, the company is yet to generate revenues from the same.
Quarter in Detail
Research and development expenses were $14.5 million for the quarter, up 37.6% from the year-ago period owing to increased costs due to new drug application (“NDA”) filings as well as increased stock compensation and personnel costs.
General and administrative expenses were $16.3 million, up 125.9% year over year. The significant increase was due to higher pre-commercialization activities related to AXS-05’s potential launch along with increased stock compensation and personnel costs.
As of Jun 30, 2021, Axsome had cash worth $141.2 million compared with $164.7 million as of Mar 31, 2021. Management believes that its cash balance as of June-end and $225 million worth term-loan facility will be enough to fund its anticipated operations at least through 2024.
Pipeline Update
Axsome’s key pipeline candidates including AXS-05, AXS-07, AXS-12 and AXS-14 are currently being developed for multiple central nervous system indications.
AXS-05
AXS-05, one of Axsome’s lead candidates, is being developed for treating major depressive disorder (“MDD”), treatment-resistant depression (“TRD”), smoking cessation and agitation associated with Alzheimer's disease (“AD”).
An NDA seeking approval for AXS-05 as a potential treatment of MDD is under review with the FDA. Following NDA approval, AXS-05 would be Axsome’s first commercial product. On Jul 30, 2021, the FDA notified the company that it has identified deficiencies within the NDA that preclude labeling discussions at this time. The FDA is yet to inform regarding the nature of deficiencies. Though the company is working on understanding the nature of the decisions, it announced that the negative development may result in a potential delay in approval of the candidate. A final decision from the FDA is expected by Aug 22, 2021. Prior to the news, Axsome anticipated the drug’s commercial launch in fourth-quarter 2021, following NDA approval.
Despite narrower-than-expected second-quarter loss, shares of Axsome fell a massive 46.5% on Aug 9, following negative news on AXS-05. In fact, Axsome’s stock has plunged 66.4% so far this year against the industry’s growth of 1.8%.
Image Source: Zacks Investment Research
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.
It completed a phase II study, MERIT, evaluating AXS-05 for TRD in second-quarter 2021. In a separate press release, Axsome announced that the study met both primary and key secondary endpoints. The 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
Others
Another lead candidate, AXS-07, has been developed for acute treatment of migraine. An NDA was filed with the FDA in second-quarter 2021. The FDA’s decision regarding acceptance of this NDA is anticipated in third-quarter 2021.
Axsome’s AXS-12 is being developed to treat narcolepsy, a sleep disorder characterized by excessive sleepiness. A placebo-controlled, parallel-group phase III study on AXS-12 for the given indication is expected to begin in third-quarter 2021.
The company is also developing AXS-14 to treat fibromyalgia. An NDA is expected to be filed in fourth-quarter 2022, following successful completion of manufacturing and other activities related to the candidate.
Axsome currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Horizon Therapeutics , Repligen (RGEN - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) . While both Horizon and Vertex sport a Zacks Rank #1 (Strong Buy), Repligen currently carries a Zacks Rank #2 (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 $4.05 in the past 30 days. The same for 2022 has risen from $5.18 to $5.64 over the same period. The stock has rallied 43.7% in the year so far.
Repligen’s earnings per share estimates for 2021 have increased from $2.26 to $2.69 in the past 30 days. The same for 2022 has risen from $2.56 to $2.94 over the same period. The stock has rallied 33.3% in the year so far.
Vertex’s earnings per share estimates for 2021 have been raised from $11.22 to $12.28 in the past 30 days. The same for 2022 has been revised upward from $12.26 to $13.02 over the same period.
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Axsome (AXSM) Q2 Earnings Top, AXS-05 Approval Likely Delayed
Axsome Therapeutics, Inc. (AXSM - Free Report) incurred a loss of 86 cents per share for second-quarter 2021, slightly narrower than the Zacks Consensus Estimate of a loss of 88 cents but wider than the year-ago loss of 49 cents.
Axsome currently does not have any approved product in its portfolio. As a result, the company is yet to generate revenues from the same.
Quarter in Detail
Research and development expenses were $14.5 million for the quarter, up 37.6% from the year-ago period owing to increased costs due to new drug application (“NDA”) filings as well as increased stock compensation and personnel costs.
General and administrative expenses were $16.3 million, up 125.9% year over year. The significant increase was due to higher pre-commercialization activities related to AXS-05’s potential launch along with increased stock compensation and personnel costs.
As of Jun 30, 2021, Axsome had cash worth $141.2 million compared with $164.7 million as of Mar 31, 2021. Management believes that its cash balance as of June-end and $225 million worth term-loan facility will be enough to fund its anticipated operations at least through 2024.
Pipeline Update
Axsome’s key pipeline candidates including AXS-05, AXS-07, AXS-12 and AXS-14 are currently being developed for multiple central nervous system indications.
AXS-05
AXS-05, one of Axsome’s lead candidates, is being developed for treating major depressive disorder (“MDD”), treatment-resistant depression (“TRD”), smoking cessation and agitation associated with Alzheimer's disease (“AD”).
An NDA seeking approval for AXS-05 as a potential treatment of MDD is under review with the FDA. Following NDA approval, AXS-05 would be Axsome’s first commercial product. On Jul 30, 2021, the FDA notified the company that it has identified deficiencies within the NDA that preclude labeling discussions at this time. The FDA is yet to inform regarding the nature of deficiencies. Though the company is working on understanding the nature of the decisions, it announced that the negative development may result in a potential delay in approval of the candidate. A final decision from the FDA is expected by Aug 22, 2021. Prior to the news, Axsome anticipated the drug’s commercial launch in fourth-quarter 2021, following NDA approval.
Despite narrower-than-expected second-quarter loss, shares of Axsome fell a massive 46.5% on Aug 9, following negative news on AXS-05. In fact, Axsome’s stock has plunged 66.4% so far this year against the industry’s growth of 1.8%.
Image Source: Zacks Investment Research
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.
It completed a phase II study, MERIT, evaluating AXS-05 for TRD in second-quarter 2021. In a separate press release, Axsome announced that the study met both primary and key secondary endpoints. The 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
Others
Another lead candidate, AXS-07, has been developed for acute treatment of migraine. An NDA was filed with the FDA in second-quarter 2021. The FDA’s decision regarding acceptance of this NDA is anticipated in third-quarter 2021.
Axsome’s AXS-12 is being developed to treat narcolepsy, a sleep disorder characterized by excessive sleepiness. A placebo-controlled, parallel-group phase III study on AXS-12 for the given indication is expected to begin in third-quarter 2021.
The company is also developing AXS-14 to treat fibromyalgia. An NDA is expected to be filed in fourth-quarter 2022, following successful completion of manufacturing and other activities related to the candidate.
Axsome Therapeutics, Inc. Price
Axsome Therapeutics, Inc. price | Axsome Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Axsome currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Horizon Therapeutics , Repligen (RGEN - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) . While both Horizon and Vertex sport a Zacks Rank #1 (Strong Buy), Repligen currently carries a Zacks Rank #2 (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 $4.05 in the past 30 days. The same for 2022 has risen from $5.18 to $5.64 over the same period. The stock has rallied 43.7% in the year so far.
Repligen’s earnings per share estimates for 2021 have increased from $2.26 to $2.69 in the past 30 days. The same for 2022 has risen from $2.56 to $2.94 over the same period. The stock has rallied 33.3% in the year so far.
Vertex’s earnings per share estimates for 2021 have been raised from $11.22 to $12.28 in the past 30 days. The same for 2022 has been revised upward from $12.26 to $13.02 over the same period.