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Windtree Therapeutics, Inc. (NASDAQ: WINT) is a pioneering biotechnology company specializing in the development of innovative therapies for critical cardiovascular and respiratory conditions. The company's advanced research and proprietary technologies aim to address significant unmet medical needs, offering hope to patients and their families.
At the core of Windtree's portfolio is its KL4 surfactant technology, a synthetic, peptide-containing surfactant structurally similar to human pulmonary surfactant. This technology is being developed for noninvasive administration via aerosolization, with a primary focus on treating Respiratory Distress Syndrome (RDS) in premature infants. The potential of this technology extends to various other respiratory diseases, promising new therapeutic avenues where few or no approved treatments exist.
In the cardiovascular domain, Windtree is advancing istaroxime, a Phase 2 candidate exhibiting unique dual mechanisms that enhance both systolic and diastolic cardiac functions. Istaroxime targets acute heart failure and cardiogenic shock, conditions with high mortality and limited treatment options. Recent collaborations, including a significant license agreement with Lee's Pharmaceutical, aim to develop and commercialize istaroxime in Greater China, reflecting its global potential.
Windtree is also exploring preclinical SERCA2a activators for heart failure, aiming to develop both intravenous and oral formulations to treat acute and chronic heart failure, respectively. Additionally, the company is advancing rostafuroxin, targeting hypertension in patients with specific genetic markers, and a preclinical atypical protein kinase C iota (aPKCi) inhibitor, for potential oncology applications.
Financially, Windtree's strategic licensing and partnerships, such as the recent agreement with Deerfield Management to retire a $15 million liability, have strengthened its balance sheet. The company is strategically positioned to advance its late-stage clinical programs while optimizing its financial resources to support ongoing and future endeavors.
Windtree's commitment to scientific innovation and strategic collaborations is poised to transform treatment paradigms in cardiovascular and respiratory care, with a robust pipeline that holds significant promise for the future.
Windtree Therapeutics (NasdaqCM: WINT) reported its Q3 2022 financial results, reflecting an operating loss of $4.7 million, a significant reduction from $8.1 million in Q3 2021. R&D expenses fell to $1.5 million, down from $4.7 million, focusing resources on istaroxime development after a successful SEISMiC study. The company announced a global license agreement with Lee's Pharmaceutical, potentially yielding up to $78.9 million. Cash and equivalents were $8.4 million, expected to fund operations into Q2 2023. Positive results in istaroxime studies were published, and a new patent was allowed by the USPTO.
Windtree Therapeutics (NasdaqCM: WINT) announced a significant milestone with the Notice of Allowance for a new patent concerning istaroxime administration, enhancing its patent estate until late 2039. This investigational drug targets acute heart failure and cardiogenic shock, demonstrating improvements in cardiac function and blood pressure without adverse cardiac events.
The new patent focuses on longer infusion durations for istaroxime, building upon existing patents and reinforcing the company’s commitment to innovation in cardiovascular therapies.
Windtree Therapeutics (WINT) announced positive results from its Phase 2 istaroxime study for early cardiogenic shock, published in the European Journal of Heart Failure. The SEISMiC study showed that istaroxime significantly improved systolic blood pressure and cardiac function without worsening renal function. These findings support istaroxime's potential as a treatment for cardiogenic shock, a condition with high mortality rates and limited effective therapies. Windtree plans to optimize dosing and is set to discuss the next Phase 3 program with the FDA.
Windtree Therapeutics (WINT) has announced a late-breaking abstract presentation for its Phase 2 clinical study of istaroxime, targeting early cardiogenic shock, at the Heart Failure Society of America's Annual Meeting on October 2. The SEISMiC study demonstrated significant improvement in systolic blood pressure within the first 6 hours and maintained benefits through 24 hours. Patients showed enhanced stroke volume and cardiac output without increased heart rate, with no worsening of renal function. Cardiogenic shock represents a market valued at $1.25 billion, highlighting the urgent need for innovative treatments.
Windtree Therapeutics, Inc. (NasdaqCM: WINT) announced that CEO Craig Fraser will present a corporate overview and hold one-on-one meetings at the Ladenburg Thalmann Healthcare Conference on September 29, 2022, at the Sofitel Hotel, New York, NY. The presentation will take place at 4:00 p.m. ET. Investors can also access a live webcast and replay on the company's Investor Relations website. Windtree focuses on late-stage interventions for acute cardiovascular disorders, including treatments like istaroxime for heart failure and other innovative compounds.
Windtree Therapeutics (NasdaqCM: WINT) announced that CEO Craig Fraser will present a corporate overview and hold virtual 1x1 meetings at the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. The presentation will be available on demand starting September 12 at 7:00 am ET. Windtree focuses on late-stage interventions for acute cardiovascular disorders, particularly developing the first-in-class treatment, istaroxime, for acute heart failure. The company also has a portfolio that includes rostafuroxin for genetically targeted hypertensive patients.
Windtree Therapeutics (NasdaqCM: WINT) has entered a global licensing agreement with Lee’s Pharmaceutical and Zhaoke Pharmaceutical for the development of its KL4 surfactant and AEROSURF® treatments for respiratory distress syndrome in preterm infants. The agreement could yield up to $78.9 million in milestones and low double-digit royalties. Lee’s and Zhaoke will cover all development costs, relieving Windtree of ongoing expenses related to the KL4 platform, thereby enhancing its financial position for core programs, particularly istaroxime for acute heart failure.
Windtree Therapeutics (NasdaqCM: WINT) reported its Q2 2022 financial results, highlighting a significant operating loss reduction to $17.5 million from $45.4 million in Q2 2021. The company achieved notable success with its Phase 2 SEISMiC study of istaroxime, demonstrating improved systolic blood pressure and cardiac function in early cardiogenic shock patients. The SEISMiC study's results have drawn positive industry interest, prompting the company to begin Phase 3 study preparations and explore licensing discussions for strategic partnerships. Windtree expects its cash runway to support operations into Q1 2023.
Windtree Therapeutics (NasdaqCM: WINT) announced positive clinical results for istaroxime in treating early cardiogenic shock, supporting a new development program. With a market potential of $1.25 billion, there is a strong demand for innovative therapies in this area. Following the promising Phase 2 SEISMiC study results, the company is engaged in discussions for partnerships and licensing opportunities to enhance shareholder value. Windtree aims to optimize resources and reduce costs while advancing istaroxime's development, focusing on creating a faster, cost-effective pathway.
Windtree Therapeutics (WINT) announced positive results from its Phase 2 study of istaroxime for early cardiogenic shock, presented at the European Society of Cardiology Heart Failure Meeting. The study met its primary endpoint, demonstrating a significant improvement in systolic blood pressure (SBP) at 6 hours compared to the control group, persisting at 24 hours. Notable secondary endpoints were also achieved, showing enhancements in cardiac function and renal maintenance. The company plans to advance the istaroxime program, aiming for further studies and regulatory discussions.
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