On Thursday, H.C. Wainwright maintained a positive stance on shares of Axsome Therapeutics (NASDAQ:AXSM), reiterating a Buy rating with a $180.00 price target. The firm's optimism follows the recent announcement that the U.S. Food and Drug Administration (FDA) has accepted for review Axsome's resubmission of its New Drug Application (NDA) for AXS-07, a treatment for acute migraine episodes.
The FDA has classified the resubmission as a Class 2 review and has set a Prescription Drug User Fee Act (PDUFA) goal date of January 31, 2025. This acceptance marks a significant milestone for Axsome as it moves closer to potentially launching AXS-07 in the United States.
According to H.C. Wainwright's analysis, the commercial launch of AXS-07 could commence shortly after the FDA's decision, and the firm anticipates that the drug could generate sales of approximately $79 million in 2025. The analyst firm also projects that AXS-07 has the potential to achieve blockbuster status, based solely on U.S. sales, by the late 2020s.
AXS-07 is designed to offer rapid and consistent relief from migraine with a reduced chance of symptom recurrence. The drug's efficacy is backed by a robust patent portfolio, with over 200 issued U.S. and international patents expected to provide market exclusivity until at least 2038.
H.C. Wainwright's reiterated Buy rating and 12-month price target of $180 reflects confidence in Axsome's ability to successfully bring AXS-07 to market and capitalize on the drug's potential in the migraine treatment landscape.
In other recent news, Axsome Therapeutics has announced the FDA's acceptance of their resubmitted New Drug Application for AXS-07, a drug intended for acute migraine treatment. The FDA has set an action goal date of January 31, 2025, for the decision on this application.
The company has also seen significant analyst activity following its recent financial reports. Wells Fargo initiated coverage on the biopharmaceutical company with an Overweight rating, while Morgan Stanley maintained an Overweight rating on Axsome shares, emphasizing the successful commercial progression of Auvelity, Axsome's treatment for major depressive disorder.
Moreover, BofA Securities upgraded Axsome Therapeutics from Neutral to Buy, expressing optimism for Auvelity's performance in neuropsychiatry markets. This came along with 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. Lastly, Citi reaffirmed its Buy rating on Axsome with a steady price target of $125. These are all recent developments in the company's journey.
InvestingPro Insights
As Axsome Therapeutics (NASDAQ:AXSM) gears up for a potentially transformative period pending FDA approval, recent data from InvestingPro provides a mixed financial snapshot. The company boasts a remarkable gross profit margin of 90.3% for the last twelve months as of Q2 2024, indicating efficient control over production costs relative to revenue. This aligns with the "Impressive gross profit margins" noted in one of the InvestingPro Tips, underscoring Axsome's capacity to generate profit from its sales.
However, it's important for investors to recognize the challenges ahead. Analysts have revised their earnings downwards for the upcoming period, suggesting that there may be concerns about the company's near-term profitability. This is further evidenced by the company's negative P/E Ratio of -14.61, which indicates that Axsome is not currently generating net income. Moreover, the company's stock is trading at a high Price / Book multiple of 44.6, reflecting a premium market valuation that may factor in future growth expectations rather than current earnings.
For those interested in Axsome's stock performance, the company has delivered a strong return over the last month, with a 14.84% increase in share price. This is part of a broader trend of positive returns over various time frames, including the last three months and year-to-date, highlighting the stock's momentum among investors.
For more insights and tips, investors can explore additional analysis on Axsome Therapeutics with the 14 other InvestingPro Tips available at InvestingPro.
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