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AXSM Up on FDA Priority Review to AXS-05 sNDA in Alzheimer's Agitation
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Key Takeaways
AXSM's shares rose 22.8% as the FDA granted priority review for AXS-05's sNDA in Alzheimer's agitation.
Priority review cuts the FDA timeline to six months, putting an approval decision on April 30, 2026.
AXSM's sNDA for AXS-05 is backed by four late-stage studies and a long-term safety study.
Shares of Axsome Therapeutics (AXSM - Free Report) were up 22.8% on Dec. 31, after it announced that the FDA had accepted the supplemental new drug application (“sNDA”) seeking approval for AXS-05 (dextromethorphan HBr and bupropion HCl) for the treatment of patients with Alzheimer’s disease agitation.
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is now expected on April 30, 2026. A filing accepted under the FDA’s Priority Review pathway reduces the review period to six months from the standard 10 months. This status is given to treatments that the FDA believes could significantly improve existing treatment options compared with standard applications.
In November 2025, Axsome filed the sNDA for AXS-05 to the FDA as a treatment for agitation in Alzheimer’s disease.
The sNDA is based on a broad clinical program for AXS-05 in Alzheimer’s agitation, including data from four pivotal late-stage studies and a long-term safety study.
The FDA had previously granted a Breakthrough Therapy designation to AXS-05 for the treatment of Alzheimer’s disease agitation.
AXSM’s Price Performance
In the past six months, shares of Axsome have rallied 73.2% compared with the industry’s increase of 22.3%.
Image Source: Zacks Investment Research
A Potential FDA Nod to AXS-05 Will Help Axsome Diversify
AXS-05 is already approved for treating adults with major depressive disorder and being marketed under the brand name Auvelity in the United States.
Auvelity is the lead product in Axsome’s commercial portfolio. Since its launch in the United States in 2022, the drug has played an instrumental role in driving the company’s top line. In the first nine months of 2025, Auvelity sales rose 77.1% on a year-over-year basis to $352 million.
Axsome is also working to expand the label of Auvelity for the larger commercial opportunity in other central nervous system disorders. Besides Alzheimer’s disease 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 shortly.
The successful development and potential approval of Auvelity in additional indications would help the drug address a broader patient population and drive sales further in the coming days.
AXSM Gets FDA Feedback for Narcolepsy Drug Filing
In a separate press release, Axsome announced that it has received formal feedback from the FDA on the plans to seek approval for another pipeline candidate, AXS-12, as a treatment for cataplexy in narcolepsy.
The feedback from the FDA confirmed that Axsome’s regulatory data package is deemed sufficient to support the submission of a new drug application (“NDA”) for AXS-12 for the treatment of cataplexy in patients with narcolepsy.
Management expects to complete the NDA submission later in January 2026. Acceptance of the final NDA will be subject to the regulatory body’s review of the complete filing.
AXS-12’s narcolepsy program includes three controlled efficacy studies and a completed long-term safety study. The FDA has previously granted an Orphan Drug designation to AXS-12 for the treatment of narcolepsy.
In the past 60 days, estimates for CorMedix’s 2026 earnings per share (EPS) have moved up from $2.49 to $2.88. CRMD stock has increased 0.3% in the past six months.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2026 EPS have moved up from $7.81 to $8.08. ANIP stock has rallied 20.9% in the past six months.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.24%.
In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from $1.82 to $1.06 for 2026. In the past six months, shares of CSTL have rallied 91.7%.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 66.11%.
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AXSM Up on FDA Priority Review to AXS-05 sNDA in Alzheimer's Agitation
Key Takeaways
Shares of Axsome Therapeutics (AXSM - Free Report) were up 22.8% on Dec. 31, after it announced that the FDA had accepted the supplemental new drug application (“sNDA”) seeking approval for AXS-05 (dextromethorphan HBr and bupropion HCl) for the treatment of patients with Alzheimer’s disease agitation.
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is now expected on April 30, 2026. A filing accepted under the FDA’s Priority Review pathway reduces the review period to six months from the standard 10 months. This status is given to treatments that the FDA believes could significantly improve existing treatment options compared with standard applications.
In November 2025, Axsome filed the sNDA for AXS-05 to the FDA as a treatment for agitation in Alzheimer’s disease.
The sNDA is based on a broad clinical program for AXS-05 in Alzheimer’s agitation, including data from four pivotal late-stage studies and a long-term safety study.
The FDA had previously granted a Breakthrough Therapy designation to AXS-05 for the treatment of Alzheimer’s disease agitation.
AXSM’s Price Performance
In the past six months, shares of Axsome have rallied 73.2% compared with the industry’s increase of 22.3%.
Image Source: Zacks Investment Research
A Potential FDA Nod to AXS-05 Will Help Axsome Diversify
AXS-05 is already approved for treating adults with major depressive disorder and being marketed under the brand name Auvelity in the United States.
Auvelity is the lead product in Axsome’s commercial portfolio. Since its launch in the United States in 2022, the drug has played an instrumental role in driving the company’s top line. In the first nine months of 2025, Auvelity sales rose 77.1% on a year-over-year basis to $352 million.
Axsome is also working to expand the label of Auvelity for the larger commercial opportunity in other central nervous system disorders. Besides Alzheimer’s disease 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 shortly.
The successful development and potential approval of Auvelity in additional indications would help the drug address a broader patient population and drive sales further in the coming days.
AXSM Gets FDA Feedback for Narcolepsy Drug Filing
In a separate press release, Axsome announced that it has received formal feedback from the FDA on the plans to seek approval for another pipeline candidate, AXS-12, as a treatment for cataplexy in narcolepsy.
The feedback from the FDA confirmed that Axsome’s regulatory data package is deemed sufficient to support the submission of a new drug application (“NDA”) for AXS-12 for the treatment of cataplexy in patients with narcolepsy.
Management expects to complete the NDA submission later in January 2026. Acceptance of the final NDA will be subject to the regulatory body’s review of the complete filing.
AXS-12’s narcolepsy program includes three controlled efficacy studies and a completed long-term safety study. The FDA has previously granted an Orphan Drug designation to AXS-12 for the treatment of narcolepsy.
Axsome Therapeutics, Inc. Price
Axsome Therapeutics, Inc. price | Axsome Therapeutics, Inc. Quote
AXSM’s Zacks Rank & Stocks to Consider
Axsome currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CorMedix (CRMD - Free Report) , ANI Pharmaceuticals (ANIP - Free Report) and Castle Biosciences (CSTL - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CorMedix’s 2026 earnings per share (EPS) have moved up from $2.49 to $2.88. CRMD stock has increased 0.3% in the past six months.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2026 EPS have moved up from $7.81 to $8.08. ANIP stock has rallied 20.9% in the past six months.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.24%.
In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from $1.82 to $1.06 for 2026. In the past six months, shares of CSTL have rallied 91.7%.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 66.11%.