Cardiogenic shock

Windtree Renews Agreement with Chang Gung University for Scientific Collaboration to Further SERCA2a Research

Retrieved on: 
Thursday, February 1, 2024

The scientific collaboration includes the Company’s lead product candidate istaroxime and the next generation compounds called SERCA2a activators.

Key Points: 
  • The scientific collaboration includes the Company’s lead product candidate istaroxime and the next generation compounds called SERCA2a activators.
  • SERCA2a activity is decreased in heart failure and disordered calcium handling can play a role in cardiac arrythmias.
  • Windtree believes activation of SERCA2a could represent an important advancement in heart failure treatment for patients.
  • Outside of this scientific collaboration, istaroxime is being studied in the Phase 2 SEISMiC Extension Study in early cardiogenic shock.

Windtree Therapeutics Announces Engagement of Strategic Advisor to Support Assessment of Strategic Alternatives

Retrieved on: 
Wednesday, January 31, 2024

WARRINGTON, Pa., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for critical cardiovascular disorders, today announced that it has engaged Ladenburg Thalmann & Co. Inc. (“Ladenburg”) to evaluate strategic alternatives for the Company with the goal of maximizing stockholder value.

Key Points: 
  • WARRINGTON, Pa., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for critical cardiovascular disorders, today announced that it has engaged Ladenburg Thalmann & Co. Inc. (“Ladenburg”) to evaluate strategic alternatives for the Company with the goal of maximizing stockholder value.
  • “While there has been positive data and progress, we believe the opportunity is under-recognized and under-valued in the current financial markets, however, it has resulted in in-bound business development interest.
  • Beyond traditional licensing, the Company will explore the potential for an acquisition, merger, further licensing, company sale or other strategic transactions.
  • The engagement of Ladenburg as strategic advisor is intended to support the board’s process and assessment of opportunities.

Windtree Eliminates $15 Million Contingent Liability to Deerfield Management Company

Retrieved on: 
Thursday, January 25, 2024

Windtree out-licensed global rights to AEROSURF® in 2022.

Key Points: 
  • Windtree out-licensed global rights to AEROSURF® in 2022.
  • “We appreciate the support of Deerfield in our efforts to strengthen our financial position with the completion of this transaction and the expected elimination the $15 million contingent liability.
  • As a result, we believe we have meaningfully strengthened and simplified our balance sheet,” said Craig Fraser, Windtree's President and Chief Executive Officer.
  • Along with significantly cutting our cash burn rate since the second half of 2022, I believe we have strengthened the company through recent transactions such as this one.

Windtree Therapeutics Announces License Agreement with Lee’s Pharmaceuticals to Develop and Commercialize Istaroxime, Dual Mechanism SERCA2a Activators and Rostafuroxin for Greater China / Asia Pacific Region

Retrieved on: 
Wednesday, January 17, 2024

WARRINGTON, Pa., Jan. 17, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for critical cardiovascular disorders, today announced it has entered into a license agreement with Lee’s Pharmaceutical (HK) Limited (“Lee’s”) for the development and commercialization of Windtree’s product candidate istaroxime in Greater China, including for acute heart failure and cardiogenic shock. In addition to istaroxime, the agreement also licenses Windtree’s preclinical next-generation SERCA2a activators, known as dual mechanism SERCA2a activators, and rostafuroxin, a Phase 2 product candidate for hypertension associated with specific genotypes.

Key Points: 
  • In addition to istaroxime, the agreement also licenses Windtree’s preclinical next-generation SERCA2a activators, known as dual mechanism SERCA2a activators, and rostafuroxin, a Phase 2 product candidate for hypertension associated with specific genotypes.
  • “We believe Windtree’s pipeline has great potential and we expect this license agreement will progress development in the treatment of heart failure.
  • Windtree already studied istaroxime in heart failure patients in China and the results of the Company’s positive Phase 2b study have been presented and published.
  • Lee’s will be responsible for funding all development, manufacturing, regulatory and commercial costs for the covered products in the licensed region.

Windtree Therapeutics Announces Reduction In Arrythmias In A New Study With Istaroxime And A Pure SERCA2a Activator

Retrieved on: 
Tuesday, January 2, 2024

WARRINGTON, Pa., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for critical cardiovascular disorders, today announced new preclinical data on the Company’s lead product candidate, istaroxime, and another preclinical pipeline drug candidate, CVie-216, showing reductions in ventricular arrythmias in a rat heart model of diabetes with restricted and restored coronary blood flow induced injury. Istaroxime and CVie-216 are each designed to act on pumps in the cardiac cells that are important in calcium handling. Istaroxime is a dual mechanism of action compound that has been shown to inhibit the sodium potassium ATPase and activates SERCA2a. CVie-216 is designed to selectively activate SERCA2a.

Key Points: 
  • Istaroxime is a dual mechanism of action compound that has been shown to inhibit the sodium potassium ATPase and activates SERCA2a.
  • Nearly 300 patients with acute decompensated heart failure were treated with istaroxime in three Phase 2 studies, including a study that evaluated patients with early cardiogenic shock.
  • Windtree is continuing to obtain data to evaluate the potential benefits of SERCA2a activation on arrythmia risk in all ongoing clinical trials.
  • This study demonstrated a reduction in arrythmias in the istaroxime and CVie-216 pretreated groups compared to the control group.

Human medicines European public assessment report (EPAR): Corlentor, ivabradine, Date of authorisation: 25/10/2005, Revision: 27, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Corlentor, ivabradine, Date of authorisation: 25/10/2005, Revision: 27, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Corlentor, ivabradine, Date of authorisation: 25/10/2005, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR): Procoralan, ivabradine, Date of authorisation: 25/10/2005, Revision: 22, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Procoralan, ivabradine, Date of authorisation: 25/10/2005, Revision: 22, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Procoralan, ivabradine, Date of authorisation: 25/10/2005, Revision: 22, Status: Authorised

Human medicines European public assessment report (EPAR): Ivabradine Anpharm, ivabradine, Date of authorisation: 08/09/2015, Revision: 10, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Ivabradine Anpharm, ivabradine, Date of authorisation: 08/09/2015, Revision: 10, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Ivabradine Anpharm, ivabradine, Date of authorisation: 08/09/2015, Revision: 10, Status: Authorised

Windtree Therapeutics Announces the Start of Patient Dosing In Phase 2 SEISMiC Extension Study of Istaroxime in Early Cardiogenic Shock

Retrieved on: 
Monday, December 18, 2023

WARRINGTON, Pa., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for critical cardiovascular disorders, today announced that the Company recently enrolled the first subject in its Phase 2 SEISMiC Extension Study of istaroxime in the treatment of early cardiogenic shock. Study results are expected in mid-2024.

Key Points: 
  • The study of hospitalized patients with early cardiogenic shock (SCAI Stage B) due to acute heart failure (AHF) will evaluate two dose regimens of istaroxime compared to placebo.
  • In the previous SEISMiC study in early cardiogenic shock, patients were infused with drug or placebo for 24 hours.
  • The Company is also progressing the start-up of a parallel study in more severe, SCAI Stage C cardiogenic shock patients.
  • The istaroxime cardiogenic shock SCAI Stage C study is expected to enroll up to 20 subjects with SCAI Stage C cardiogenic shock due to AHF.

Windtree Therapeutics Reports Third Quarter 2023 Financial Results and Provides Key Business Updates

Retrieved on: 
Thursday, November 9, 2023

WARRINGTON, Pa., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today reported financial results for the third quarter ended September 30, 2023 and provided key business updates.

Key Points: 
  • WARRINGTON, Pa., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today reported financial results for the third quarter ended September 30, 2023 and provided key business updates.
  • “During the third quarter, we initiated our plan to move the istaroxime program in cardiogenic shock to Phase 3 readiness by advancing two clinical trials.
  • Research and development expenses were $2.1 million for the third quarter of 2023, compared to $1.5 million for the third quarter of 2022.
  • General and administrative expenses for the third quarter of 2023 were $2.6 million, compared to $2.7 million for the third quarter of 2022.