Istaroxime

Windtree Therapeutics Partners with Evofem to Manufacture FDA-Approved Contraceptive PHEXXI

2 months ago

• Windtree Therapeutics has entered into a License and Supply Agreement with Evofem Biosciences to become the sourcing partner for PHEXXI, a hormone-free contraceptive vaginal gel that generated over $19 million in annual revenue in 2024. • The partnership aims to significantly reduce manufacturing costs for PHEXXI, potentially enabling Evofem to expand into new price-sensitive global markets where non-hormonal contraceptives are in high demand. • This agreement represents the first step in Windtree's recently announced corporate strategy to transform into a revenue-generating biotechnology company while continuing development of its therapeutic pipeline.

Gilead's Trodelvy Receives FDA Breakthrough Therapy Designation for SCLC; Seladelpar Recommended for EU Approval

5 months ago

• The FDA granted Breakthrough Therapy Designation to Gilead's Trodelvy for extensive-stage small cell lung cancer (ES-SCLC) after platinum-based chemotherapy, based on promising results from the TROPiCS-03 study. • Gilead will collaborate with Terray Therapeutics to discover and develop novel, small molecule therapies across multiple targets, leveraging Terray's tNova platform. • The European Medicines Agency's CHMP recommended approval of Gilead's seladelpar for primary biliary cholangitis (PBC) in combination with UDCA or as monotherapy.

Windtree's Istaroxime Shows Promise in Cardiogenic Shock Treatment and Arrhythmia Prevention

5 months ago

• Alexandre Mebazaa presented positive Phase 2b data on istaroxime for early cardiogenic shock at the Cardiovascular Clinical Trials Conference. • Istaroxime is a first-in-class therapy improving cardiac function and blood pressure without increasing heart rate, showing a favorable safety profile. • Windtree has filed a patent application in India for istaroxime, aiming to protect its use in preventing myocardial arrhythmias. • The company is advancing istaroxime towards Phase 3 trials, driven by promising Phase 2 results and the drug's unique mechanism of action.

Windtree Therapeutics Partners with New Growth Advisors to Explore Strategic Options for Istaroxime

6 months ago

• Windtree Therapeutics has engaged New Growth Advisors to explore strategic options for its cardiovascular portfolio, including istaroxime, following positive Phase 2 results. • The partnership aims to secure non-dilutive funding through potential out-licensing or asset sale of istaroxime and next-generation SERCA2a activators. • Windtree plans to use proceeds from any deal to advance its oncology platform and progress its cardiovascular program with a partner. • Lee's Pharmaceuticals is expected to initiate Phase 3 trials of istaroxime in acute heart failure within their licensed territory in the first half of 2025.

Windtree and Intensity Therapeutics Report Progress in Heart Failure and Oncology

6 months ago

• Windtree Therapeutics reported positive Phase 2b results for istaroxime in early cardiogenic shock, showing significant improvements in cardiac function and blood pressure. • Intensity Therapeutics initiated a Phase 3 trial for INT230-6 in soft tissue sarcoma and a Phase 2 trial in triple-negative breast cancer. • Both companies provided financial updates, highlighting research and development expenses and cash runway into 2025.

Windtree Therapeutics Initiates SEISMiC-C Trial of Istaroxime in Cardiogenic Shock

6 months ago

• Windtree Therapeutics has begun enrolling patients in the SEISMiC-C trial to evaluate istaroxime in SCAI Stage C cardiogenic shock, a severe form of heart failure. • The SEISMiC-C trial is a global, placebo-controlled, double-blind study assessing istaroxime's impact on systolic blood pressure and cardiac function over six hours. • Istaroxime aims to improve systolic contraction and diastolic relaxation, potentially avoiding harmful side effects associated with current inotropic or vasopressor drugs. • Windtree anticipates data from the SEISMiC-C trial will inform Phase 3 readiness and facilitate discussions with regulatory agencies in 2025.

Windtree Therapeutics to Present Istaroxime Data at ThinkEquity Conference

7 months ago

• Windtree Therapeutics will present a corporate update at the ThinkEquity Conference on October 30th, focusing on Istaroxime. • The presentation will highlight positive topline data from the Phase 2b SEISMiC Extension Study of Istaroxime in early cardiogenic shock. • Istaroxime is a first-in-class therapy with a dual mechanism to improve systolic and diastolic cardiac function without increasing heart rate. • Windtree's management will also engage in one-on-one meetings with investors during the conference to discuss company strategy and milestones.

Istaroxime Shows Promise in Improving Cardiac Function in Early Cardiogenic Shock

8 months ago

• Windtree Therapeutics' istaroxime significantly improved systolic blood pressure in heart failure patients with early cardiogenic shock in a Phase 2b trial. • The study demonstrated that istaroxime enhances cardiac output and renal function without increasing heart rate or causing significant arrhythmias. • Istaroxime treatment led to improvements in NYHA heart failure classification and reduced instances of worsening heart failure compared to placebo. • These results support the potential of istaroxime as a novel therapy for early cardiogenic shock, addressing critical needs in heart failure management.

Windtree Therapeutics Advances Istaroxime for Cardiogenic Shock

10 months ago

• Windtree Therapeutics is nearing completion of enrollment for its Phase 2b SEISMiC Extension Study of istaroxime in early cardiogenic shock patients, with topline data expected by the end of the quarter. • A parallel study in more severe SCAI Stage C cardiogenic shock patients is progressing, evaluating istaroxime in addition to standard of care, with systolic blood pressure as the primary endpoint. • Windtree has a licensing agreement with Lee’s Pharmaceutical for istaroxime development and commercialization in Greater China, including acute heart failure and cardiogenic shock. • Istaroxime, a first-in-class dual-mechanism therapy, aims to improve systolic and diastolic cardiac function without increasing heart rate or cardiac rhythm disturbances.

Drug Development Updates