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WARRINGTON, Pa. - Windtree Therapeutics, Inc. (NASDAQ:WINT), a biotechnology firm with a market capitalization of $3.63 million and currently trading near its 52-week low, has revealed a strategy that could secure 7.5 years of U.S. market exclusivity for its cardiac drug istaroxime, pending FDA approval. The company’s CEO, Jed Latkin, announced the potential for New Chemical Entity (NCE) designation, which would grant istaroxime five years of data exclusivity and a stay of generic competition for an additional 2.5 years in the event of patent litigation.
Istaroxime, currently in Phase 2 trials, is being studied for its efficacy in treating cardiogenic shock, a serious condition characterized by the heart’s inability to supply sufficient blood to the body. The SEISMiC C study, a global trial, is evaluating the drug’s impact on systolic blood pressure and other cardiac function measures when combined with standard therapies. According to InvestingPro analysis, the company faces significant financial challenges, with an EBITDA of -$24.43 million in the last twelve months.
The drug’s dual-action mechanism aims to improve both systolic and diastolic heart function by inhibiting Na+/K+- ATPase and activating the SERCA2a calcium pump, which has shown promise in improving cardiac function without adverse effects on heart rate or rhythm.
Windtree’s interim analysis of the Phase 2 cardiogenic shock study is scheduled for Q3, 2025. The company also holds method of use patents for istaroxime in the U.S., with protections extending until 2039 and pending patents until 2043.
The company’s broader portfolio includes other early and late-stage therapies for critical conditions, as well as a licensing business model with existing partnerships. With a current ratio of 0.45, InvestingPro data indicates the company’s short-term obligations exceed its liquid assets. The information in this article is based on a press release statement from Windtree Therapeutics. For comprehensive financial analysis and additional insights, including 16 more ProTips, visit InvestingPro.
In other recent news, Windtree Therapeutics has announced its return to compliance with Nasdaq’s minimum bid price requirement, ensuring continued listing on the stock market. The company achieved this by maintaining a closing bid price of over $1.00 for at least 10 consecutive trading days. In a separate development, Windtree has issued Senior Secured Promissory Notes to raise $250,000, with a 10% annual interest rate and a maturity date set for January 4, 2026. This move is part of a financing agreement with two institutional investors, as detailed in a recent SEC filing. Additionally, Windtree Therapeutics has received a Notice of Allowance from the U.S. Patent and Trademark Office for an intravenous formulation of istaroxime, aimed at treating acute heart failure. The company also approved a 1-for-50 reverse stock split, effective February 20, 2025, to elevate its per-share trading price and maintain Nasdaq compliance. Furthermore, Windtree Therapeutics announced the resignation of board member Craig Fraser, reducing the board’s size from five to four members. These developments reflect the company’s ongoing efforts to secure funding, enhance its intellectual property portfolio, and maintain regulatory compliance.
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