Robinhood shares gain on Q2 beat, as user and crypto growth accelerate
On Tuesday, Piper Sandler analysts reiterated their Overweight rating and maintained a $148 price target for Axsome Therapeutics stock (NASDAQ: NASDAQ:AXSM), which currently trades at $110.13 with a market capitalization of $5.47 billion. According to InvestingPro data, the stock has delivered an impressive 53% return over the past year. This decision follows the company’s announcement that it received a Refuse to File (RTF) letter from the U.S. Food and Drug Administration (FDA) concerning its New Drug Application (NDA) for AXS-14, an oral norepinephrine reuptake inhibitor intended for fibromyalgia treatment.
The FDA’s RTF letter was issued despite both studies included in the NDA meeting their primary endpoints. The agency did not view one of the studies, a smaller Phase II trial with flexible dosing, as adequate to support the filing. Consequently, the FDA requested Axsome conduct a confirmatory Phase III trial. The company maintains strong fundamentals, with InvestingPro data showing exceptional gross profit margins of 91.5% and robust revenue growth of 72.2% in the last twelve months.
Piper Sandler analysts acknowledged the setback but emphasized that this development is not a significant driver for Axsome’s shares. They noted that the additional study could be beneficial, given the lack of new agent approvals in the fibromyalgia space over the past decade.
The analysts believe Axsome can effectively use its existing commercial infrastructure to support the new study. They continue to view the potential of AXS-14 positively, maintaining their Overweight rating and $148 price target for the company’s stock. Based on InvestingPro’s Fair Value analysis, the stock appears slightly undervalued at current levels. Subscribers can access additional insights and 7 more ProTips for AXSM through the comprehensive Pro Research Report.
In other recent news, Axsome Therapeutics received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) concerning its New Drug Application for AXS-14, aimed at fibromyalgia management. The FDA found the application incomplete, citing inadequacies in one of the placebo-controlled trials due to its 8-week primary endpoint and flexible-dose approach. Despite this, the FDA acknowledged the adequacy of the first trial with a 12-week endpoint and fixed-dose paradigm. Axsome plans to conduct an additional trial in the fourth quarter of 2025 to meet FDA requirements. Analysts from H.C. Wainwright maintained a Buy rating and a $180 price target on Axsome stock, viewing the FDA’s feedback as constructive. Meanwhile, Oppenheimer reduced its price target to $183 from $185 but retained an Outperform rating, noting that the market had not significantly valued AXS-14. The company remains focused on its other products, such as Auvelity and the upcoming Symbravo launch. Axsome’s CEO emphasized the importance of advancing AXS-14 development to address the unmet needs of fibromyalgia patients in the U.S.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.