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Opus Genetics, Inc., a pharmaceutical company based in Durham, NC, with a market capitalization of $31.57 million and a "FAIR" financial health rating according to InvestingPro, disclosed in a recent SEC filing that they received a Paragraph IV Certification Notice from Sandoz (SIX:SDZ) Incorporated. The notice, dated January 2025, informs Opus Genetics that Sandoz has filed an Abbreviated New Drug Application (ANDA) with the FDA to produce a generic version of RYZUMVI™, a drug currently patented by Opus Genetics.
The ANDA submission by Sandoz challenges the validity and enforceability of six Opus Genetics patents listed in the FDA’s Orange Book. These patents, identified by their numbers—9,795,560; 10,278,918; 10,772,829; 11,090,261; 11,844,858; and 11,400,077—are alleged by Sandoz to be either invalid, unenforceable, or not infringed by their proposed generic product. Notably, Sandoz’s challenge does not extend to two additional RYZUMVI™ patents, numbers 12,201,615 and 12,201,616.
In response to the ANDA filing and the Notice Letter, Opus Genetics or its commercial partner may opt to initiate a patent infringement lawsuit to defend the intellectual property rights related to RYZUMVI™. The company’s course of action will likely be determined based on the defense of its commercial interests and the protection of its patents.
The SEC filing also contains forward-looking statements regarding Opus Genetics’ intentions to enforce its intellectual property rights. However, these statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from expectations.
The company’s filing emphasizes that these forward-looking statements are based on the current state of affairs and that they may change due to various factors, including those outlined under "Risk Factors" in their most recent quarterly report and other SEC filings. InvestingPro data reveals the company maintains strong liquidity with a current ratio of 6.63, though analysts have recently revised earnings expectations downward. Get access to 8 more exclusive ProTips and comprehensive financial analysis with InvestingPro.
This news is based on statements from a press release and reflects the information provided by Opus Genetics, Inc. in its Form 8-K filed with the Securities and Exchange Commission. As of today, the company has not made any further comments on the potential legal actions or the impact of the patent challenge on its business operations. The stock has experienced significant pressure, down over 60% in the past year, with analyst price targets ranging from $8 to $15 per share.
In other recent news, Opus Genetics has made significant strides in its clinical trials and corporate activities. The company completed enrollment for its VEGA-3 Phase 3 trial, testing Phentolamine Ophthalmic Solution 0.75% for presbyopia, and received Fast Track designation from the FDA to expedite the drug’s development. The LYNX-2 trial is also nearing full enrollment, targeting night driving impairment post-keratorefractive surgery. In their gene therapy endeavors, Opus Genetics dosed the first pediatric patient in a Phase 1/2 trial for Leber congenital amaurosis and plans to present further adult trial results in 2025.
Opus Genetics also announced a $40 million at-the-market equity program with Leerink Partners LLC, intended to support general corporate purposes, including clinical trials. The company revised executive compensation agreements for its CEO and CFO, enhancing severance terms related to changes in control. Additionally, Opus Genetics scheduled its 2025 Annual Meeting of Stockholders for April 30, with new deadlines for stockholder proposals and nominations. These developments reflect Opus Genetics’ ongoing efforts in advancing its pipeline and corporate governance.
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