NEW YORK - Axsome Therapeutics, Inc. (NASDAQ:AXSM), a developer of therapies for central nervous system disorders, has reached a settlement with Unichem Laboratories Ltd. in a patent lawsuit concerning Axsome's narcolepsy drug Sunosi (solriamfetol). The agreement allows Unichem to launch a generic version of the drug in the U.S. on June 30, 2042, subject to certain conditions and possible extensions.
The settlement concludes the dispute initiated by Unichem's filing of an Abbreviated New Drug Application for a generic equivalent of Sunosi, which is currently under litigation in the United States District Court for the District of New Jersey. As part of the legal process, the agreement will be reviewed by the U.S. Federal Trade Commission and the Department of Justice.
Axsome continues to pursue similar patent infringement cases against other entities concerning Sunosi, which remains a significant product in the company's portfolio. These ongoing legal efforts reflect Axsome's broader strategy to defend its intellectual property rights and maintain market exclusivity for its approved products.
This announcement is based on a press release statement from Axsome Therapeutics, Inc.
In other recent news, Axsome Therapeutics has seen a significant surge in its financial performance and market prospects. The company reported a substantial year-over-year revenue increase of approximately 160% in the first quarter of 2024, with total net product revenue reaching $75 million. The firm's products, Auvelity and Sunosi, have shown positive performance, with Auvelity prescriptions growing by 12% quarter-over-quarter.
RBC Capital maintained its Outperform rating on Axsome Therapeutics' shares, increasing the price target to $130.00, up from $127.00. This adjustment reflects a positive outlook on the intellectual property surrounding Auvelity, potentially leading to extended market exclusivity until 2040.
Piper Sandler reaffirmed its Overweight rating on Axsome Therapeutics, with a steady price target of $115.00. The firm's stance followed a survey of neurologists, indicating that AXS-05, also known as Auvelity, is viewed as an effective treatment option for Alzheimer's disease agitation.
Despite facing a cyberattack that temporarily impacted Auvelity's weekly prescriptions, Axsome managed to maintain a strong commercial foundation. The company is optimistic about its future, expecting continued commercial and pipeline momentum throughout 2024.
InvestingPro Insights
As Axsome Therapeutics (NASDAQ:AXSM) navigates the competitive landscape of the pharmaceutical industry, recent data from InvestingPro provides a nuanced view of the company's financial health and market performance. With a market capitalization of $3.46 billion USD, Axsome's financial metrics show a mixed picture. The company's impressive gross profit margin stands at 90.12% for the last twelve months as of Q1 2024, indicating strong profitability potential on its products. However, the P/E Ratio (Adjusted) for the same period is -13.56, reflecting market skepticism about the company's earnings potential in the near term. Additionally, Axsome's Price / Book ratio is notably high at 24.04, suggesting that the stock may be valued richly relative to the company's book value.
InvestingPro Tips for Axsome highlight several strategic considerations for investors. The company's liquid assets surpass its short-term obligations, which may provide financial flexibility and resilience against market fluctuations. On the other hand, analysts have revised their earnings expectations downwards for the upcoming period, and they do not anticipate Axsome will be profitable this year. These insights, coupled with the fact that Axsome does not pay a dividend to shareholders, could influence investment decisions depending on individual risk tolerance and investment goals.
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