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Liminatus Pharma, Inc. (NASDAQ:LIMN), a $245 million market cap biotech company whose stock has declined nearly 47% in the past week, announced Wednesday that it has entered into a memorandum of understanding to form a research and development consortium with Samda Biolab Co., Ltd. and INNOCS AI. According to InvestingPro data, the company’s shares currently trade at $9.57, showing significant volatility in recent periods. The initiative aims to advance a novel blood-based diagnostic kit for early detection of pancreatic cancer, according to a press release statement included in a regulatory filing with the Securities and Exchange Commission.
The consortium will focus on the CA19-9-combined INNOCS diagnostic platform, which was jointly developed by Samda Biolab and INNOCS AI. The platform uses a deep learning algorithm alongside a panel of 16 metabolomic biomarkers. Recent clinical data cited in the filing, from a cohort of 1,086 subjects including 393 pancreatic cancer patients and 693 control subjects, showed the combined approach demonstrated sensitivity above 95% and specificity above 99%. The method was reported to detect CA19-9-negative pancreatic tumors.
Liminatus Pharma stated it will contribute clinical development expertise and regulatory guidance as part of the consortium. The company is expected to lead the regulatory approval process for the diagnostic kit through both the U.S. Food and Drug Administration and the Korean Ministry of Food and Drug Safety once the product moves to commercialization.
As part of its role, Liminatus Pharma will oversee the acquisition of larger clinical datasets necessary for regulatory submissions. Before beginning the FDA filing process, the company intends to complete internal approvals supporting a definitive agreement on investment, commercialization, and go-to-market strategy.
The company cited projections that the global pancreatic cancer diagnostics market could reach $3 billion by 2026, with the blood-based diagnostics segment expected to surpass $700 million and the high-risk population screening segment estimated at over $100 million. InvestingPro analysis indicates the company maintains a Fair financial health score of 2.18, though it currently operates at a loss with negative earnings per share of $0.14.
Liminatus Pharma’s common stock and warrants are listed on the Nasdaq Stock Market LLC under the symbols LIMN and LIMNW, respectively. The information is based on a statement contained in a recent SEC filing.
In other recent news, Liminatus Pharma Inc has regained compliance with Nasdaq’s listing requirements, a development that has instilled confidence among investors. The company received a notification from Nasdaq confirming its adherence to Listing Rule 5250(c)(1), which mandates timely filing of reports with the U.S. Securities and Exchange Commission. This comes after Liminatus addressed a delay in filing its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025. By filing the required report, the company has brought its Exchange Act reporting obligations up to date. This resolution ensures Liminatus will continue to be listed on the Nasdaq, allowing it to maintain access to public capital markets essential for funding its research and development activities. The swift action taken by the company underscores its commitment to good corporate governance practices. Investors are likely to monitor Liminatus’s progress with its cancer therapy developments and adherence to financial reporting standards. These factors are pivotal to the company’s growth trajectory and investment appeal.
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