On Tuesday, H.C. Wainwright reaffirmed its Buy rating on Axsome Therapeutics (NASDAQ:AXSM) shares, maintaining a price target of $180.00. Currently trading at $84.78, the stock shows significant upside potential according to analyst consensus.
InvestingPro analysis indicates the stock is currently undervalued, with 7 analysts recently revising their earnings expectations upward. The endorsement follows Axsome's announcement on Monday regarding the successful completion of its Phase 3 clinical trials for AXS-05, a novel treatment for Alzheimer’s disease-associated agitation.
The Phase 3 program consisted of several trials, including ACCORD-2, ADVANCE-2, and a long-term safety study. The ACCORD-2 trial notably met its primary endpoint, demonstrating that AXS-05 significantly delayed the time to relapse of agitation in patients compared to a placebo.
This development is particularly significant for Axsome, which has demonstrated impressive revenue growth of 51.47% over the last twelve months and maintains a robust gross profit margin of 91.09%. For deeper insights into Axsome's financial health and growth metrics, InvestingPro subscribers have access to over 30 additional key indicators. The results indicated a 3.6-fold lower risk of relapse for patients treated with AXS-05.
AXS-05 also achieved success in a key secondary endpoint focused on relapse prevention. The positive outcomes from these trials have significantly bolstered the treatment's profile. H.C. Wainwright's analysis points to the potential market impact and effectiveness of AXS-05, as reflected in their reiterated price target and rating.
The analyst from H.C. Wainwright highlighted the statistical significance of the findings, with a p-value of 0.001 in the hazard ratio for time to relapse, assessed by the Cohen-Mansfield Agitation Inventory (CMAI) total score. These results are critical for patients with Alzheimer’s disease as agitation is a common and challenging symptom to manage.
In conclusion, H.C. Wainwright's reiterated Buy rating and price target for Axsome Therapeutics underscore the firm's confidence in the potential of AXS-05 as a significant advancement in the treatment of AD-associated agitation. The successful clinical trial outcomes serve as a solid foundation for the company's valuation and future prospects.
With a market capitalization of $4.11 billion and a healthy current ratio of 2.44, the company appears well-positioned for growth. Access the complete Axsome Therapeutics research report and discover more valuable insights through InvestingPro's comprehensive analysis tools.
In other recent news, Axsome Therapeutics has seen a flurry of developments. Mizuho (NYSE:MFG) has revised Axsome's stock target to $122 while maintaining an Outperform rating, highlighting the potential of AXS-05 and upcoming Phase 3 readouts for another of Axsome's drugs, solriamfetol.
Baird analysts have reiterated their Outperform rating for Axsome, maintaining a $116.00 price target, despite mixed phase 3 results for AXS-05 in Alzheimer's disease agitation. Leerink Partners have also sustained their Outperform rating and $110.00 price target for Axsome, even in the wake of recent clinical trial outcomes for Axsome's drug Auvelity.
These recent developments underscore Axsome's robust financial performance, with the company reporting record-breaking revenue for the third quarter, surpassing $100 million for the first time. This financial milestone was primarily driven by the sales of its major depressive disorder treatment, Auvelity, and its excessive daytime sleepiness medication, Sunosi.
In addition, Guggenheim's report suggests that the FDA's decision on Auvelity, expected in 2026, could significantly impact Axsome's stock. The firm maintains that the overall data supports a Buy case for Axsome stock, with the potential for the stock to rise to the $130 range upon approval of Auvelity.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.