Axsome Therapeutics, Inc. AXSM announced positive data from the phase III ACCORD study evaluating its candidate, AXS-05, for treating Alzheimer’s disease (AD) agitation. Currently, there is no approved therapy for the given indication.
The placebo-controlled, randomized withdrawal ACCORD study treated 178 patients with AD agitation.
Data from the same showed that treatment with AXS-05 led to statistically significant delayed time for the relapsing of AD agitation as compared to placebo – the study’s primary endpoint. Treatment with AXS-05 also statistically significantly prevented relapse of AD agitation versus placebo – the secondary endpoint of the study.
Shares of Axsome were up 31.5% on Monday following the announcements of the news. The stock has surged 97.8% so far this year against the industry’s decline of 19.6%.
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Per the company, data from the ACCORD study complement and are similar to the data from the previously completed ADVANCE-1 study.
In September 2022, AXSM initiated the ADVANCE-2 phase III study evaluating AXS-05 for treating AD agitation.
Alzheimer’s disease is the most common form of dementia. It is a progressive neurodegenerative disorder causing cognitive decline and other behavioral and psychological symptoms, including agitation.
The target market represents a massive opportunity. If the study progresses well, a potential label expansion of AXS-05 will majorly boost Axsome’s portfolio.
AXS-05 is an oral investigational N-methyl-D-aspartate receptor antagonist with multimodal activity. The company is developing the candidate for various central nervous system disorders.
AXS-05, marketed by the trade name Auvelity, was approved by the FDA for the treatment of major depressive disorder in August 2022, making it the first approved drug in Axsome’s portfolio. Auvelity was commercially launched in October 2022.
AXS-05 is also being investigated in the phase II MERIT study to address patients with treatment-resistant depression and a candidate for smoking cessation.
Zacks Rank & Stocks to Consider
Axsome currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are ASLAN Pharmaceuticals Limited ASLN, Immunocore Holdings plc IMCR and Angion Biomedica Corp. ANGN, all carrying a Zacks Rank #2 (Buy) at present.You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for ASLAN Pharmaceuticals have narrowed 6.1% for 2022 and 5.7% for 2023 in the past 60 days.
Earnings of ASLAN Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ASLN witnessed an earnings surprise of 1.64% on average.
Loss per share estimates for Immunocore have narrowed 39.7% for 2022 and 39.4% for 2023 in the past 60 days.
Earnings of Immunocore surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. IMCR witnessed an earnings surprise of 68.34% on average.
Loss per share estimates for Angion Biomedica have narrowed 6.1% for 2022 and 3.9% for 2023 in the past 60 days.
Earnings of Angion Biomedica surpassed estimates in three of the trailing four quarters and missed the mark on the other occasion. ANGN witnessed an earnings surprise of 66.42% on average.
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