NEW YORK - Axsome Therapeutics Inc . (NASDAQ:AXSM), a $4.2 billion market cap biopharmaceutical company, announced positive outcomes from its latest Phase 3 clinical trials for AXS-05, a treatment for agitation in Alzheimer’s disease patients. The ACCORD-2 study met its primary endpoint, demonstrating a statistically significant delay in the time to relapse of agitation symptoms compared to a placebo. The treatment also achieved a key secondary endpoint, preventing the relapse of agitation.
The ACCORD-2 trial, which assessed AXS-05’s efficacy in maintaining a sustained clinical response, showed a 3.6-fold lower risk of relapse compared to the placebo. Additionally, AXS-05 was found to prevent worsening of overall Alzheimer’s disease severity. According to InvestingPro data, Axsome has demonstrated impressive revenue growth of 51.47% over the last twelve months, with a remarkable gross profit margin of 91.09%.
Although the ADVANCE-2 trial did not reach statistical significance for its primary endpoint, the results for the primary and nearly all secondary endpoints numerically favored AXS-05 over placebo. Across both trials, AXS-05 was well tolerated with no reported deaths, increased risk of falls, cognitive decline, or sedation.
The positive results from the ACCORD-2 trial are consistent with those from two previous Phase 3 trials, ADVANCE-1 and ACCORD-1, which also supported the efficacy of AXS-05 in treating Alzheimer’s disease agitation. The long-term safety of AXS-05 has been further demonstrated in a trial with over 300 patients treated for at least six months.
With these findings, Axsome plans to submit a New Drug Application to the FDA for AXS-05 in the second half of 2025. AXS-05 has already received Breakthrough Therapy designation, potentially expediting its development and review.
Today, Axsome will host a conference call and webcast to discuss these topline results. Dr. Jeffrey Cummings, Vice Chair of Research at UNLV Department of Brain Health, will join the call and be available for questions.
Alzheimer’s disease agitation presents significant challenges for patients and caregivers, often leading to accelerated cognitive decline and increased caregiver burden. AXS-05’s potential to address this high unmet need could represent a significant advancement in Alzheimer’s disease management. Based on InvestingPro’s Fair Value analysis, Axsome’s stock currently appears undervalued, with analyst price targets ranging from $105 to $180 per share.
This report is based on a press release statement from Axsome Therapeutics.
In other recent news, RBC Capital Markets highlighted several biotech companies in its "Biotech Outlook" report, including Regeneron (NASDAQ:REGN) Pharmaceuticals, which received an "Outperform" rating. Despite competition, RBC Capital anticipates robust growth drivers for Regeneron, including new treatments and significant clinical readouts. Amgen Inc (NASDAQ:AMGN)., Sarepta Therapeutics (NASDAQ:SRPT), Legend Biotech, and Axsome Therapeutics also received "Outperform" ratings from RBC Capital, indicating promising prospects for these companies.
Axsome Therapeutics reported positive results from the ENCORE Phase 3 trial for its drug candidate AXS-12, used in the treatment of narcolepsy with cataplexy. The company intends to move towards an NDA filing for AXS-12 and request a pre-NDA meeting with the FDA. Axsome also reported record-breaking revenue for the third quarter, surpassing $100 million for the first time, marking an 81% year-over-year increase.
Mizuho (NYSE:MFG) Securities updated its financial model for shares of Axsome Therapeutics, resulting in an increased price target for the company’s stock. The adjustment comes after a post-third quarter evaluation and the inclusion of revenue projections for solriamfetol, for two additional potential indications: attention-deficit/hyperactivity disorder (ADHD) and major depressive disorder (MDD). Phase 3 data readouts for each indication are anticipated in the first quarter of 2025.
H.C. Wainwright maintained a Buy rating and a $180.00 stock price target on Axsome Therapeutics, highlighting the company’s strong financial performance in the third quarter of 2024. Axsome’s revenue for the quarter exceeded expectations, coming in at $104.8 million, surpassing the analyst’s projection of $93.9 million. RBC Capital Markets adjusted its outlook on shares of Axsome Therapeutics, increasing the price target to $132 from the previous $131, while maintaining an Outperform rating on the shares.
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