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AXSM Gets Positive FDA Feedback for Alzheimer's Agitation Drug Filing
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Axsome Therapeutics (AXSM - Free Report) announced that it has received formal feedback from the FDA on its plans to seek approval for AXS-05 as a treatment for agitation in Alzheimer’s disease (AD) patients.
The written feedback from the agency confirmed that Axsome’s regulatory data package is deemed sufficient to support the submission of a supplemental new drug application (sNDA) for AXS-05 in agitation associated with AD. Management expects to submit this sNDA in the third quarter of 2025.
Since AXS-05 has been granted breakthrough therapy designation in the above indication, we expect the FDA to grant the company’s sNDA filing a priority review.
The sNDA will be supported by data from four pivotal late-stage studies, which showed that treatment with AXS-05 led to a statistically significant delay in the time to relapse of agitation, assessed by the Cohen-Mansfield Agitation Inventory total score in AD patients compared to placebo. Also, treatment with AXS-05 reduced the worsening for overall AD severity compared to placebo.
AXS-05 is already approved for treating adults with major depressive disorder (MDD) and is being marketed under the brand name Auvelity.
AXSM Stock Performance
Shares of Axsome Therapeutics have surged more than 50% in the past year compared with the industry’s 6% growth.
Image Source: Zacks Investment Research
Auvelity: A Key Revenue Driver for Axsome
Auvelity is the biggest product in Axsome’s portfolio. Since its commercial launch in the United States in 2022, the drug has played an instrumental role in driving the company’s top line in the past few years. Despite being approved only for MDD indication, Axsome added $291 million from the drug’s sales, indicating a 124% year-over-year improvement.
Axsome is also working to expand the label of Auvelity for the larger commercial opportunity in other CNS disorders. Apart from AD agitation, Axsome is also developing Auvelity for smoking cessation. The company is planning to initiate a phase II/III pivotal study on AXS-05 for smoking cessation later this year.
The successful development and subsequent commercialization of Auvelity in additional indications would help the drug address a broader patient population and drive sales further in the coming days.
AXSM’s Zacks Rank
Axsome Therapeutics currently carries a Zacks Rank #4 (Sell).
Estimates for Pacira BioSciences’ 2025 EPS have increased from $3.10 to $3.59 over the past 60 days, and the same for 2026 has risen from $3.42 to $4.30. PCRX’s shares have surged 22% year to date.
Pacira’s earnings beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average surprise of 8.58%.
Estimates for argenx’s 2025 EPS have increased from $9.08 to $11.14 over the past 60 days, while the same for 2026 has increased from $17.59 to $19.45. ARGX’s shares have gained more than 1% year to date.
argenx's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 345.11%.
Estimates for 89bio’s loss per share have narrowed from $3.19 to $2.40 for 2025 in the past 60 days. ETNB’s shares have risen nearly 14% year to date.
89bio’s earnings missed estimates in three of the trailing four quarters and beat the mark on one occasion, delivering an average negative surprise of 46.18%.
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AXSM Gets Positive FDA Feedback for Alzheimer's Agitation Drug Filing
Axsome Therapeutics (AXSM - Free Report) announced that it has received formal feedback from the FDA on its plans to seek approval for AXS-05 as a treatment for agitation in Alzheimer’s disease (AD) patients.
The written feedback from the agency confirmed that Axsome’s regulatory data package is deemed sufficient to support the submission of a supplemental new drug application (sNDA) for AXS-05 in agitation associated with AD. Management expects to submit this sNDA in the third quarter of 2025.
Since AXS-05 has been granted breakthrough therapy designation in the above indication, we expect the FDA to grant the company’s sNDA filing a priority review.
The sNDA will be supported by data from four pivotal late-stage studies, which showed that treatment with AXS-05 led to a statistically significant delay in the time to relapse of agitation, assessed by the Cohen-Mansfield Agitation Inventory total score in AD patients compared to placebo. Also, treatment with AXS-05 reduced the worsening for overall AD severity compared to placebo.
AXS-05 is already approved for treating adults with major depressive disorder (MDD) and is being marketed under the brand name Auvelity.
AXSM Stock Performance
Shares of Axsome Therapeutics have surged more than 50% in the past year compared with the industry’s 6% growth.
Image Source: Zacks Investment Research
Auvelity: A Key Revenue Driver for Axsome
Auvelity is the biggest product in Axsome’s portfolio. Since its commercial launch in the United States in 2022, the drug has played an instrumental role in driving the company’s top line in the past few years. Despite being approved only for MDD indication, Axsome added $291 million from the drug’s sales, indicating a 124% year-over-year improvement.
Axsome is also working to expand the label of Auvelity for the larger commercial opportunity in other CNS disorders. Apart from AD agitation, Axsome is also developing Auvelity for smoking cessation. The company is planning to initiate a phase II/III pivotal study on AXS-05 for smoking cessation later this year.
The successful development and subsequent commercialization of Auvelity in additional indications would help the drug address a broader patient population and drive sales further in the coming days.
AXSM’s Zacks Rank
Axsome Therapeutics currently carries a Zacks Rank #4 (Sell).
Axsome Therapeutics, Inc. Price
Axsome Therapeutics, Inc. price | Axsome Therapeutics, Inc. Quote
Our Key Picks Among Biotech Stocks
Some better-ranked stocks are Pacira BioSciences (PCRX - Free Report) , argenx (ARGX - Free Report) and 89bio (ETNB - Free Report) . While PCRX sports a Zacks Rank #1 (Strong Buy), ARGX and ETNB carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Pacira BioSciences’ 2025 EPS have increased from $3.10 to $3.59 over the past 60 days, and the same for 2026 has risen from $3.42 to $4.30. PCRX’s shares have surged 22% year to date.
Pacira’s earnings beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average surprise of 8.58%.
Estimates for argenx’s 2025 EPS have increased from $9.08 to $11.14 over the past 60 days, while the same for 2026 has increased from $17.59 to $19.45. ARGX’s shares have gained more than 1% year to date.
argenx's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 345.11%.
Estimates for 89bio’s loss per share have narrowed from $3.19 to $2.40 for 2025 in the past 60 days. ETNB’s shares have risen nearly 14% year to date.
89bio’s earnings missed estimates in three of the trailing four quarters and beat the mark on one occasion, delivering an average negative surprise of 46.18%.