Axsome Reveals Data From Alzheimer's Studies, Analyst Sees Hope Despite Mixed Trial Results

Benzinga2024-12-31

On Monday, Axsome Therapeutics, Inc. (NASDAQ:AXSM) released data from ACCORD-2, ADVANCE-2, and long-term safety trials AXS-05 (dextromethorphan-bupropion) in Alzheimer's disease agitation. The ACCORD-...

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Further, AXS-05 reduced the worsening of overall Alzheimer's disease severity compared to the placebo.Also Read: Axsome Therapeutics' AXS-12 Data For Sleeping Disorder Boosts Confidence In Approval And Market Potential, Analyst Says. 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Further, AXS-05 reduced the worsening of overall Alzheimer's disease severity compared to the placebo.\nAlso Read: Axsome Therapeutics' AXS-12 Data For Sleeping Disorder Boosts Confidence In Approval And Market Potential, Analyst Says\nThe ADVANCE-2 Phase 3 trial did not demonstrate statistical significance for the primary endpoint in delaying the time to relapse of agitation from baseline to Week 5, with reductions of 13.8 and 12.6 points for AXS-05 and placebo, respectively.\nHowever, results for the primary and nearly all secondary endpoints numerically favored AXS-05 over placebo.\nAXS-05 was safe and well tolerated in both controlled studies.\nThe long-term safety and tolerability of AXS-05 were also evaluated in more than 300 subjects treated for at least 6 months and more than 100 treated for at least 12 months.\nIn the controlled and long-term studies in subjects with Alzheimer's disease, AXS-05 was not associated with an increased risk of falls, cognitive decline, or sedation.\nIn the clinical program for AXS-05 in Alzheimer's disease agitation, there have been no deaths in subjects receiving AXS-05.\nAxsome plans to submit an NDA for AXS-05 in Alzheimer's disease agitation to the FDA in the second half of 2025.\nWilliam Blair writes that the data from the trials represent a mixed scenario for investors to digest how regulators will interpret the total pivotal data package for AXS-05 in Alzheimer's disease agitation.\nThe analyst notes that neuropsychiatry drugs have been approved based on their overall data, even if they faced setbacks in key trials.\nExamples include Intra-Cellular Therapies Inc's (NASDAQ:ITCI) Caplyta and Johnson & Johnson's (NYSE:JNJ) esketamine.\nWilliam Blair notes the approval of Otsuka Holdings Co Ltd (OTC:OTSKY) (OTC:OTSKF) Rexulti for Alzheimer's-related agitation, despite mixed trial results, is a strong comparison for Axsome's AXS-05.\nHowever, a key difference is that Rexulti's approval relied on placebo-controlled parallel group studies, while Axsome is expected to depend on results from the ADVANCE-1 and ACCORD-1/2 trials to meet the FDA's requirement for two well-controlled studies.\nThe analyst remains optimistic about AXS-05's approval, highlighting that the FDA's continued designation of AXS-05 as a breakthrough therapy reflects the high unmet need in this area, which could work in Axsome's favor.\nPrice Action: AXSM stock is up 2.62% to $87.00 premarket at the last check on Tuesday.\nRead Next:\n\nTrump Administration to Challenge Social Media Censorship, Setting Stage for Conflict with EU Regulations\n\nLatest Ratings for AXSM\n\n\n\nDate\nFirm\nAction\nFrom\nTo\n\n\n\n\nMar 2022\nSVB Leerink\nMaintains\n\nOutperform\n\n\nNov 2021\nSVB Leerink\nMaintains\n\nOutperform\n\n\nAug 2021\nHC Wainwright & Co.\nMaintains\n\nBuy\n\n\n\n View More Analyst Ratings for AXSM \n View the Latest Analyst Ratings \nUNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets.\nGet the latest stock analysis from Benzinga?\n\nAXSOME THERAPEUTICS (AXSM): Free Stock Analysis Report\n\nThis article Axsome Reveals Data From Alzheimer's Studies, Analyst Sees Hope Despite Mixed Trial Results originally appeared on Benzinga.com\n© 2024 Benzinga.com. Benzinga does not provide investment advice. 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