’Reddit is built for this moment’ - Stock soars on crushed earnings
NEW YORK - Axsome Therapeutics, Inc. (NASDAQ: AXSM), a $5.26 billion market cap company specializing in central nervous system (CNS) disorder treatments, has announced positive trial results for two of its drugs at the American Academy of Neurology Annual Meeting in San Diego, California. According to InvestingPro analysis, the company’s stock, currently trading at $107.89, appears undervalued based on its Fair Value metrics, despite a strong 49% return over the past year.
The company presented findings from the ACCORD-2 Phase 3 trial of AXS-05, a treatment for agitation in Alzheimer’s disease, and the SYMPHONY Phase 3 trial of AXS-12 for narcolepsy. Additionally, a network meta-analysis of SYMBRAVO®, a migraine treatment, was showcased. The company maintains impressive gross profit margins of 91.37%, reflecting efficient operations in its pharmaceutical development programs.
AXS-05, which is an investigational drug combining dextromethorphan and bupropion, showed efficacy and safety in the Phase 3 trial for Alzheimer’s disease agitation. The U.S. FDA has previously granted AXS-05 Breakthrough Therapy designation for this indication.
The SYMPHONY trial’s topline results indicated AXS-12, a selective norepinephrine reuptake inhibitor, to be effective in treating narcolepsy. AXS-12 has also received Orphan Drug Designation from the FDA for this condition.
For migraine treatment, the network meta-analysis presented at the meeting compared SYMBRAVO® to other oral CGRPs, showcasing its efficacy. SYMBRAVO®, which combines MoSEIC™ meloxicam and rizatriptan, is approved for the acute treatment of migraine with or without aura in adults.
The presentations at the AAN meeting are based on a press release statement and highlight Axsome’s ongoing efforts to develop innovative treatments for CNS disorders. The company holds an extensive patent portfolio for its products, with protection extending to at least 2043 for AXS-05 and to at least 2039 for AXS-12.
Axsome’s commitment to addressing unmet needs in CNS conditions is reflected in its diverse portfolio, which includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as late-stage development programs for other neurological and psychiatric conditions.
The positive trial results contribute to the company’s mission to provide significant advancements in patient outcomes for CNS disorders affecting millions of people in the United States. With revenue growth of 42.53% in the last twelve months and a strong current ratio of 2.11, Axsome demonstrates both operational momentum and financial stability. For deeper insights into Axsome’s financial health and growth prospects, including 12 additional ProTips and comprehensive valuation metrics, visit InvestingPro, where you’ll find detailed analysis in our exclusive Pro Research Report.
In other recent news, Axsome Therapeutics announced that its Phase 3 PARADIGM trial of solriamfetol for major depressive disorder (MDD) did not achieve the primary endpoint of statistical significance in the overall patient population. However, a subgroup of patients with severe excessive daytime sleepiness (EDS) showed greater improvements in depressive symptoms, prompting plans for a new Phase 3 trial focusing on this subgroup in 2025. Guggenheim and BofA Securities both reiterated their Buy ratings on Axsome, with price targets of $195 and $174, respectively, despite the trial setback. Mizuho Securities maintained an Outperform rating with a $216 price target, expressing confidence in Axsome’s long-term growth potential.
In other developments, Axsome reported positive Phase 3 results for adult ADHD patients and plans to conduct a second trial for pediatric patients later this year. Analysts from BofA Securities highlighted the potential of Auvelity in the MDD market and its expansion into treating Alzheimer’s agitation. They also noted the upcoming launch of Symbravo for migraines in 2025 as a significant factor in Axsome’s valuation. Despite recent challenges, analysts maintain a positive outlook on Axsome, emphasizing its potential for new product launches by the end of 2026.
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