NEW YORK - Axsome Therapeutics, Inc. (NASDAQ: NASDAQ:AXSM), a company specializing in central nervous system (CNS) disorder treatments, has announced the FDA's acceptance of their resubmitted New Drug Application (NDA) for AXS-07, intended for acute migraine treatment. The FDA has set a Prescription Drug User Fee Act (PDUFA) action goal date of January 31, 2025, for the decision on this application.
Migraine, a neurological condition causing severe headaches and associated symptoms, affects an estimated 39 million Americans. Surveys indicate dissatisfaction with existing treatments, highlighting a demand for faster and more consistent relief with fewer recurrences.
AXS-07, which combines MoSEIC™ meloxicam and rizatriptan, aims to address these needs. MoSEIC™ meloxicam is designed for quick absorption and prolonged effect, while rizatriptan is known for targeting specific receptors involved in migraine. The combination is intended to offer rapid and sustained migraine relief. AXS-07 is currently not approved by the FDA and is protected by over 200 issued patents, with protection extending to at least 2038.
Axsome Therapeutics is focused on developing novel therapies for CNS conditions, including migraine, that lack adequate treatment options. The company's portfolio also includes other products such as Sunosi® and Auvelity®, with ongoing efforts to expand their indications.
The FDA's acceptance of the NDA resubmission follows comprehensive clinical trials and research by Axsome to substantiate the efficacy and safety of AXS-07. The PDUFA date is the FDA's deadline for a decision on the drug's approval.
The information in this article is based on a press release statement from Axsome Therapeutics.
In other recent news, Axsome Therapeutics has seen a slew of analyst activity following its recent financial reports. Wells Fargo (NYSE:WFC) initiated coverage on the biopharmaceutical company with an Overweight rating and a price target of $140.00 per share, based on a detailed discounted cash flow analysis. Morgan Stanley (NYSE:MS) maintained an Overweight rating on Axsome shares, highlighting the successful commercial progression of Auvelity, Axsome's treatment for major depressive disorder that has reported approximately $254 million in sales since its launch.
BofA Securities upgraded Axsome Therapeutics from Neutral to Buy, with a revised price target of $106, expressing optimism for Auvelity's performance in neuropsychiatry markets. This came alongside H.C. Wainwright's adjustment of its price target for Axsome to $180 from $190, maintaining a Buy rating, following mixed Q2 results.
RBC Capital slightly reduced Axsome's price target to $130 from $131 but maintains an Outperform rating, noting continued growth for Auvelity and upcoming significant events for the company. Citi reaffirmed its Buy rating on Axsome with a steady price target of $125, reflecting the potential of Axsome's drug for Alzheimer's disease agitation, AXS-05, and the commercial prospects of its treatments in development. These are recent developments in the company's journey.
InvestingPro Insights
As Axsome Therapeutics (NASDAQ: AXSM) awaits the FDA's decision on their novel migraine treatment, AXS-07, the company's financial health and market performance are key indicators for investors. With a substantial market capitalization of $4.3 billion, Axsome stands out in the biopharmaceutical sector, where market cap can often reflect investor confidence in a company's pipeline and future growth potential.
The company's impressive gross profit margin of 90.3% over the last twelve months as of Q2 2024 demonstrates its ability to maintain profitability on a per-unit basis, which is crucial for sustaining operations and funding ongoing research and development. However, it's important to note that analysts have tempered expectations, revising their earnings downwards for the upcoming period, signaling caution as Axsome continues to invest heavily in its drug pipeline without having reached profitability yet.
Investors looking for stability in price may find comfort in Axsm's low price volatility, suggesting that the stock does not experience wide swings in market price, which can be a desirable trait for risk-averse investors. This is further supported by the stock's strong return over the last three months, boasting a 24.1% price total return, reflecting positive investor sentiment in the short term.
For those interested in further insights, there are additional InvestingPro Tips available for Axsome Therapeutics, providing a deeper dive into the company's financials and market performance. Visit https://www.investing.com/pro/AXSM for more detailed analysis and tips.
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