SAN DIEGO, CA - Heron Therapeutics, Inc. (NASDAQ:HRTX), a pharmaceutical company with a market capitalization of approximately $179 million, announced a favorable court ruling today in a patent infringement lawsuit concerning its anti-nausea medication, CINVANTI. The company's stock has shown strong momentum, gaining nearly 11% over the past week, according to InvestingPro data.
The U.S. District Court for the District of Delaware found in favor of Heron, affirming the validity of two of its patents and determining that the proposed generic version by Fresenius Kabi USA, LLC would infringe on these patents.
The contested patents, U.S. Patent Nos. 9,561,229 and 9,974,794, are set to expire in 2035. The ruling prevents Fresenius Kabi from launching a generic version of CINVANTI in the U.S. market until after the patents' expiration date, barring any successful appeals or other legal challenges. The court has requested Heron to submit a proposed final judgment by December 9, 2024.
This litigation began when Fresenius Kabi submitted an Abbreviated New Drug Application (ANDA) to the FDA, seeking to manufacture and sell a generic version of CINVANTI before the expiration of Heron's patents. Heron responded by filing a patent infringement lawsuit on July 27, 2022. After a series of legal proceedings, including a four-day bench trial and oral arguments, the court ruled in Heron's favor.
The District Court's decision is a significant win for Heron Therapeutics, ensuring market exclusivity for CINVANTI for the duration of the patent terms. CINVANTI is used in the prevention of chemotherapy-induced nausea and vomiting, a common side effect of cancer treatment. The company maintains a healthy financial position with a current ratio of 2.28, indicating strong ability to meet short-term obligations, while achieving 12% revenue growth in the last twelve months.
Heron's statement on the matter included forward-looking remarks regarding the potential timing for Fresenius Kabi's generic product launch in the U.S., which is now anticipated to be no earlier than September 18, 2035. The company also cautioned that forward-looking statements are subject to risks and uncertainties, and actual results could differ materially.
This legal update is based on information disclosed in a press release statement from Heron Therapeutics and the recent court ruling. Heron Therapeutics trades on The Nasdaq Capital Market under the ticker symbol NASDAQ:HRTX. Analysts maintain an optimistic outlook on the stock, with price targets ranging from $4 to $9. For comprehensive analysis and additional insights, including 8 more ProTips and detailed financial metrics, visit InvestingPro, where you can access the complete Pro Research Report for HRTX.
In other recent news, Heron Therapeutics has issued an updated financial forecast for Q4 of 2024, anticipating net revenues between $37 million and $43 million. The company's positive projection comes after the FDA approved its Vial Access Needle (VAN), a development expected to enhance the administration of its drug, ZYNRELEF. Additionally, the upcoming NOPAIN Act, promoting non-opioid alternatives, is poised to boost ZYNRELEF's adoption starting January 2025.
Heron Therapeutics has also reported an over 12% increase in year-to-date revenue, with gross margins seeing a substantial rise, resulting in a doubling of gross profit. The company has narrowed its full-year revenue guidance to $140 million to $146 million and projects a positive adjusted EBITDA ranging from $2 million to $5 million. A significant reduction in net loss for the quarter was also noted, along with a robust cash position.
The company is planning to launch the VAN product in early December 2024, targeting select accounts. It also expects a recovery in Q4 for CINVANTI, backed by a new sales strategy. Lastly, the Prefilled Syringe program is reportedly on track, with approval aimed for late 2026 to early 2027. These are some of the recent developments within Heron Therapeutics.
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