FDA Events for Windtree Therapeutics (WINT)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Windtree Therapeutics (WINT).
Over the past two years, Windtree Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Istaroxime. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Istaroxime - FDA Regulatory Timeline and Events
Istaroxime is a drug developed by Windtree Therapeutics for the following indication: Cardiogenic Shock in severe acute heart failure.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Istaroxime
- Announced Date:
- June 16, 2025
- Indication:
- Cardiogenic Shock in severe acute heart failure
Announcement
Windtree Therapeutics, announced that the istaroxime early cardiogenic shock Phase 2 study called SEISMiC B is published in the Journal of Heart and Lung Transplantation and is available on the journal website.
AI Summary
Windtree Therapeutics announced that its Phase 2 SEISMiC B study on istaroxime in early cardiogenic shock has been published in the Journal of Heart and Lung Transplantation. The study, titled “Safety and Efficacy Intravenous Istaroxime up to 60 hours for Patients with Pre-Cardiogenic Shock,” is now available on the journal’s website. It demonstrates that istaroxime significantly increases blood pressure during the first six hours of treatment and maintains these effects over 60 hours. In addition, the treatment improved cardiac output, lowered pulmonary capillary wedge pressure, and showed no increase in heart rate or significant rhythm issues, while preserving kidney function. These results suggest that istaroxime could be a promising new option for patients with poor heart function and low blood pressure, potentially offering a better alternative to current treatments.
Read Announcement- Drug:
- Istaroxime
- Announced Date:
- May 22, 2025
- Estimated Event Date Range:
- July 1, 2025 - July 31, 2025
- Target Action Date:
- July 1, 2025
- Indication:
- Cardiogenic Shock in severe acute heart failure
Announcement
Windtree Therapeutics, announced it is targeting the planned interim analysis results for the istaroxime cardiogenic shock SEISMiC SCAI Stage C Phase 2 study (the "SEISMiC C Study") for July 2025.
AI Summary
Windtree Therapeutics announced that it is targeting the interim analysis results for its SEISMiC C Study, a Phase 2 clinical trial for SCAI Stage C cardiogenic shock, in July 2025. The global trial, conducted at sites in the United States, Europe, and Latin America, is designed as a placebo-controlled and double-blinded study. Istaroxime will be administered alongside the current standard of care, which may include inotropes or vasopressors, to assess its impact on systolic blood pressure (SBP) over the first six hours of treatment. The study also aims to evaluate improvements in cardiac function and potential reductions in the use of supportive medications. Interim results, based on data from the first 20 patients, will provide an early look at istaroxime’s efficacy and safety, serving as a crucial milestone in advancing the therapy toward a Phase 3 program.
Read Announcement- Drug:
- Istaroxime
- Announced Date:
- May 12, 2025
- Indication:
- Cardiogenic Shock in severe acute heart failure
Announcement
Windtree Therapeutics, announced istaroxime and a selective SERCA2a activator data furthering the demonstration of reduction in arrythmias in an animal study.
AI Summary
Windtree Therapeutics recently announced new animal study results showing that istaroxime and its metabolite analog, CVie216, significantly reduce arrhythmias. The research, presented as a poster at the European Society of Cardiology Heart Failure Conference, used a rat model where ischemia-reperfusion induced heart damage and arrhythmias. By activating the protein SERCA2a, responsible for calcium reuptake in heart cells, these compounds helped lower the frequency of spontaneous calcium release events that can lead to irregular heartbeats.
The findings support previous work indicating that istaroxime and its analog can improve cardiac performance and reduce dangerous arrhythmias. This data may offer a promising new approach to treating heart failure and cardiomyopathy patients, who are particularly at risk for arrhythmia-related complications. Windtree’s study provides an important step toward developing therapies that address the underlying causes of these heart rhythm disturbances.
Read Announcement- Drug:
- Istaroxime
- Announced Date:
- December 4, 2024
- Indication:
- Cardiogenic Shock in severe acute heart failure
Announcement
Windtree Therapeutics, announced that it has engaged New Growth Advisors ("NGA"), a leading life sciences consulting firm chosen by companies seeking discreet, conflict-free, and knowledgeable advice on complex M&A, asset sale, research, capital markets, and licensing transactions, as its strategic advisor to lead a process in respect of Windtree's cardiovascular portfolio, including a potential out-licensing transaction or asset sale.
AI Summary
Windtree Therapeutics announced that it has engaged New Growth Advisors (NGA) as its strategic advisor for its cardiovascular portfolio. NGA, a well-known life sciences consulting firm specializing in complex transactions such as M&A, asset sales, and licensing deals, will lead a process that may include a potential out-licensing transaction or the sale of assets. This move comes as Windtree seeks to build on its promising early and Phase 2b cardiogenic shock results, aiming to secure non-dilutive funding through a partnership. The advisory process managed by NGA is intended to handle both current inbound interest and an expanded out-licensing process, ensuring Windtree can efficiently explore opportunities for its first-in-class cardiovascular assets.
The company hopes that a successful partnership will not only advance its cardiovascular program but also help fund its innovative preclinical oncology platform further.
Read Announcement- Drug:
- Istaroxime
- Announced Date:
- October 9, 2024
- Indication:
- Cardiogenic Shock in severe acute heart failure
Announcement
Windtree Therapeutics, announced the trial design of its SEISMiC Phase 2b has been published by the European Society of Cardiology Heart Failure.
AI Summary
Windtree Therapeutics recently announced that the trial design of its SEISMiC Phase 2b study has been published by the European Society of Cardiology Heart Failure. The published article, titled “Safety and efficacy of up to 60 hours of intravenous istaroxime in pre-cardiogenic shock patients: Design of the SEISMiC trial,” details key aspects of the study such as the design, procedures, assessments, outcome measures, and endpoints. This Phase 2b trial aims to investigate istaroxime, a novel first-in-class therapy that seeks to improve heart function by enhancing both contraction and relaxation, while also supporting blood pressure and kidney function. The publication of this trial design is an important milestone for Windtree Therapeutics as it builds momentum in advancing the clinical evaluation of istaroxime toward Phase 3 readiness in treating early cardiogenic shock.
Read Announcement- Drug:
- Istaroxime
- Announced Date:
- September 30, 2024
- Indication:
- Cardiogenic Shock in severe acute heart failure
Announcement
Windtree Therapeutics, announced positive topline clinical results for its Phase 2b SEISMiC Extension Study of istaroxime in heart failure patients in early cardiogenic shock.
AI Summary
Windtree Therapeutics recently announced positive topline results from its Phase 2b SEISMiC Extension Study of istaroxime in heart failure patients experiencing early cardiogenic shock. The study demonstrated that istaroxime significantly improved systolic blood pressure, cardiac output, and renal function compared to placebo, all without increasing heart rate or causing clinically significant arrhythmias. Patients also experienced improved heart failure symptoms, with the New York Heart Association classification showing marked improvements up to 72 hours after treatment.
The study involved extended dosing up to 60 hours, indicating that longer treatment may offer additional benefits. These results support istaroxime’s unique dual mechanism of action, helping the heart contract more effectively and relax more efficiently. Windtree Therapeutics is encouraged by these results as they continue to explore the potential of istaroxime in future Phase 3 clinical trials for patients in early cardiogenic shock.
Read Announcement- Drug:
- Istaroxime
- Announced Date:
- September 26, 2024
- Indication:
- Cardiogenic Shock in severe acute heart failure
Announcement
Windtree Therapeutics, Inc announced it will hold a virtual Investor Day Presentation on October 1 at 3pm ET.
AI Summary
Windtree Therapeutics, Inc. announced that it will hold a virtual Investor Day Presentation on October 1 at 3pm ET via Zoom. During the event, the company will present the promising topline results from its Phase 2b SEISMiC Extension Study of istaroxime in early cardiogenic shock. The presentation will focus on the study’s findings as well as Windtree’s future strategy and near-term milestones in advancing this novel therapy. Istaroxime is designed to improve both systolic contraction and diastolic relaxation while also increasing blood pressure and supporting kidney function. The session will feature key insights into these developments and include a live Q&A session. Dr. Alexandre Mebazaa, a respected expert in cardiogenic shock and heart failure, will join the management team to provide his expertise during the presentation. Investors can register online for this event.
Read Announcement- Drug:
- Istaroxime
- Announced Date:
- September 25, 2024
- Indication:
- Cardiogenic Shock in severe acute heart failure
Announcement
Windtree Therapeutics, announced positive topline results from its Phase 2b SEISMiC Extension Study of istaroxime in significantly increasing systolic blood pressure over six hours, a critical clinical objective in treating patients in early cardiogenic shock due to heart failure.
AI Summary
Windtree Therapeutics announced positive topline results from its Phase 2b SEISMiC Extension Study of istaroxime. The study met its primary endpoint by significantly increasing systolic blood pressure over six hours in patients experiencing early cardiogenic shock due to heart failure. Researchers evaluated two dosing regimens of istaroxime compared to a placebo, with patients receiving infusions for up to 60 hours. Along with the primary endpoint, the study showed significant improvements in many secondary endpoints related to heart function and overall safety. The trial was conducted across several regions including the United States, Europe, and Latin America, and collected detailed information on cardiac and renal performance without an increase in cardiac arrhythmias. Additional study data and dosing details will be presented at an upcoming Heart Failure Society of America meeting, highlighting istaroxime’s potential as a promising treatment option in acute heart failure.
Read Announcement- Drug:
- Istaroxime
- Announced Date:
- September 4, 2024
- Indication:
- Cardiogenic Shock in severe acute heart failure
Announcement
Windtree Therapeutics announced it has successfully completed enrollment in its SEISMiC Extension Phase 2b study of istaroxime in early cardiogenic shock caused by heart failure.
AI Summary
Windtree Therapeutics announced that it has successfully completed enrollment for its SEISMiC Extension Phase 2b study of istaroxime in patients with early cardiogenic shock due to heart failure. The study is designed to test whether a longer dosing duration and tapered dosing regimen can improve heart function and stabilize low blood pressure in these patients. Istaroxime, a novel first-in-class therapy, has already shown promising results in previous trials by improving both systolic contraction and diastolic relaxation without increasing cardiac arrhythmias. The new study, conducted across the United States, Europe, and Latin America, aims to optimize the dosing approach and gather more detailed information on the drug’s safety and effectiveness. Windtree Therapeutics hopes that the positive outcomes from this extension study will support the progress of istaroxime into Phase 3 trials soon.
Read Announcement
Windtree Therapeutics FDA Events - Frequently Asked Questions
As of now, Windtree Therapeutics (WINT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Windtree Therapeutics (WINT) has reported FDA regulatory activity for Istaroxime.
The most recent FDA-related event for Windtree Therapeutics occurred on June 16, 2025, involving Istaroxime. The update was categorized as "Publication," with the company reporting: "Windtree Therapeutics, announced that the istaroxime early cardiogenic shock Phase 2 study called SEISMiC B is published in the Journal of Heart and Lung Transplantation and is available on the journal website."
Currently, Windtree Therapeutics has one therapy (Istaroxime) targeting the following condition: Cardiogenic Shock in severe acute heart failure.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:WINT) was last updated on 7/11/2025 by MarketBeat.com Staff
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