Windtree Therapeutics announces a U.S. patent for istaroxime, a potential treatment for acute heart failure, effective until 2039.
Quiver AI Summary
Windtree Therapeutics, Inc. announced the issuance of a new patent for istaroxime, an intravenous formulation aimed at treating acute heart failure (AHF), a condition responsible for 1.3 million hospitalizations annually in the U.S., especially among the elderly. The patent, granted by the United States Patent and Trademark Office, provides protection for istaroxime until 2039, as the drug approaches Phase 3 readiness in treating cardiogenic shock and AHF. Istaroxime is positioned as a first-in-class therapy that enhances cardiac function through a dual mechanism, demonstrating positive results in previous Phase 2 studies. CEO Jed Latkin emphasized the importance of this patent in reinforcing the company's intellectual property and the potential for innovative treatments in AHF.
Potential Positives
- Issuance of a patent for istaroxime strengthens Windtree Therapeutics' intellectual property position, providing protection until 2039.
- If approved, istaroxime represents a novel treatment for acute heart failure, potentially addressing a significant unmet medical need in a large patient population.
- Positive Phase 2 study results for istaroxime enhance prospects for its approval and market acceptance in treating acute heart failure and cardiogenic shock.
- The development of istaroxime as a first-in-class dual-mechanism therapy positions the company as a leader in innovative heart failure treatments.
Potential Negatives
- The press release relies heavily on forward-looking statements, indicating uncertainty about the approval and market success of istaroxime, which could lead to investor concern regarding the company's future.
- Potential risks associated with manufacturing and regulatory requirements are highlighted, which could impact the company's ability to bring istaroxime to market successfully.
- The mention of geopolitical tensions and supply chain disruptions introduces additional external risks that may negatively affect the company's operations and product development timelines.
FAQ
What is istaroxime?
Istaroxime is a first-in-class dual-mechanism therapy designed to improve cardiac function in acute heart failure patients.
What is the significance of the new patent for istaroxime?
The patent secures protection for istaroxime in the U.S. until 2039 if approved for acute heart failure.
How effective is istaroxime in clinical studies?
Clinical studies show that istaroxime can significantly enhance cardiac function and blood pressure without raising heart rate.
What conditions does istaroxime target?
Istaroxime is designed to treat acute heart failure and early cardiogenic shock.
What is Windtree Therapeutics focused on?
Windtree Therapeutics aims to become a revenue-generating company in multiple industries, particularly in innovative therapeutics.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
1.3 million patients are hospitalized annually in the U.S. from acute heart failure and it is the #1 cause of hospitalization in patients >65 years old
If istaroxime is approved in the US for acute heart failure, this patent would provide protection to 2039
WARRINGTON, Pa., July 02, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a diversified company focused on revenue generation in multiple growing industries is pleased to announce that the United States Patent and Trademark Office has issued an istaroxime patent for the United States - application number 18/150,870 directed to “ISTAROXIME-CONTAINING INTRAVENOUS FORMULATION FOR THE TREATMENT OF ACUTE HEART FAILURE.”
Acute heart failure, or AHF, impacts millions of patients globally and istaroxime has previously completed two positive Phase 2 AHF studies and two positive early cardiogenic shock studies caused by acute heart failure.
“We are pleased to strengthen our intellectual property for istaroxime with this patent for the United States,” said Jed Latkin, CEO of Windtree. “Istaroxime is approaching Phase 3 readiness in cardiogenic shock and acute heart failure. If istaroxime is approved in AHF, this patent would provide protection until 2039. We believe the profile of istaroxime is differentiated from currently available drugs and drug treatment innovation is desired for patients.”
About Istaroxime
Istaroxime is a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure demonstrate that istaroxime infused intravenously can significantly improve cardiac function and blood pressure without increasing heart rate or the incidence of clinically significant cardiac rhythm disturbances.
About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is a diversified company focused on becoming a revenue generating company in a multitude of growing industries to drive toward overall profitability.
Forward Looking Statements
The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include, among other things: the Company’s risks and uncertainties associated with the success and advancement of its product candidates; the Company’s ability to manage costs and execute on its operational and budget plans; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, and other materials on a timely basis and in sufficient amounts; risks relating to regulatory requirements; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates, if approved; the impacts of political unrest, including as a result of geopolitical tension, and any sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company’s operations, including through disruption in supply chain or access to potential international clinical trial sites. These and other risks are described in the Company’s periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at
www.sec.gov
. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Contact Information:
Eric Curtis
[email protected]