Istaroxime

Windtree Eliminates $15 Million Contingent Liability to Deerfield Management Company

Retrieved on: 
Thursday, January 25, 2024
Heart, Windtree Therapeutics, Istaroxime, Therapy, Cardiogenic shock, White lung, Pharmaceutical industry

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

Retrieved on: 
Tuesday, January 2, 2024
Patient, Survivor, Risk, Cardiogenic shock, ATPase, Acute decompensated heart failure, Catecholamine, Istaroxime, Mortality, Disease, Diabetes, Windtree Therapeutics, Blood, Incidence, Cardiomyopathy, Therapy, Clinical trial, Heart, Rat, Heart failure, Medicare, Cardiac output, Arrhythmia, Pharmaceutical industry

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.

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
Blood pressure, Cardiogenic shock, AHF, Istaroxime, Windtree Therapeutics, SCAI, Therapy, Heart, Seismology, Patient, Safety, Pharmaceutical industry

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 Appoints Mark Strobeck, Ph.D. to Board of Directors

Retrieved on: 
Tuesday, June 27, 2023
GSK, Business development, Rockwell Medical, Drug development, University, Doctor of Philosophy, Cardiovascular disease, Business, AstraZeneca, Dialysis, Rockwell, St. Lawrence University, Investment, Patient, CBO, Assertio Therapeutics, Drug discovery, Biology, Istaroxime, Therapy, Pharmacology, Sanofi Pasteur, Pharmaceutical industry, Windtree Therapeutics

WARRINGTON, Pa., June 27, 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 announced that the Company appointed Mark Strobeck, Ph.D. to its Board of Directors.

Key Points: 
  • WARRINGTON, Pa., June 27, 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 announced that the Company appointed Mark Strobeck, Ph.D. to its Board of Directors.
  • Craig Fraser, Windtree's President and Chief Executive Officer said, “We are pleased to welcome Mark as a new independent director to Windtree's Board of Directors.
  • Mark will be highly complementary to our existing Board of Directors which includes Dan Geffkin, Leslie Williams, Dr.
  • The Company has a number of strategic opportunities and clinical milestones ahead and I look forward to supporting Windtree to help drive value for patients and shareholders."

Windtree Therapeutics to Host Virtual R&D and Investor Day Focusing on the Cardiogenic Shock Market, Istaroxime, Company Strategy and Planned Near-Term Milestones

Retrieved on: 
Monday, June 5, 2023
San Francisco, Heart, Acute decompensated heart failure, Cardiogenic shock, Heart failure, European Heart Journal, Istaroxime, MD, Patient, Disease, Therapy, Pharmaceutical industry

WARRINGTON, Pa., June 05, 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 announced it will host a virtual R&D and Investor Day on Wednesday, June 14, 2023 at 1:00 PM ET. The program will feature the Company’s lead drug candidate, istaroxime, a first in class, dual-acting agent, being developed to treat cardiogenic shock and acute decompensated heart failure. Istaroxime is designed to improve systolic contraction and diastolic relaxation of the heart.

Key Points: 
  • The program will feature the Company’s lead drug candidate, istaroxime, a first in class, dual-acting agent, being developed to treat cardiogenic shock and acute decompensated heart failure.
  • Istaroxime is designed to improve systolic contraction and diastolic relaxation of the heart.
  • Members of Windtree’s leadership team will present istaroxime early cardiogenic shock study data and provide insight into the istaroxime expanded development strategy and planned near-term milestones.
  • Additionally, strategy related to acute heart failure, the follow-on oral, SERCA2a activators and business development will be discussed.

Windtree Therapeutics Reports Fourth Quarter and Year-End 2022 Financial Results and Provides Key Business Updates

Retrieved on: 
Monday, April 3, 2023
Exercise, SBP, AHF, Cardiogenic shock, Heart failure, Efficacy, WINT, Research, Experiment, American Society for Pharmacology and Experimental Therapeutics, Biomarker, Arrhythmia, Doctor of Philosophy, Istaroxime, Science, CCU, THT, Heart, Journal, Publication, Patent, MD, Patient, Annual report, Risk, Average cost, Toxicology, Security (finance), ICU, Therapy, Metabolite, Safety, Seismology, Conference, FESC, Pharmaceutical industry, Medical device, Cryptocurrency, Life insurance, Windtree Therapeutics, Pharmacology

WARRINGTON, Pa., April 03, 2023 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for cardiovascular disorders, today reported financial results for the fourth quarter and fiscal year ended December 31, 2022 and provided key business updates.

Key Points: 
  • WARRINGTON, Pa., April 03, 2023 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for cardiovascular disorders, today reported financial results for the fourth quarter and fiscal year ended December 31, 2022 and provided key business updates.
  • Research and development expenses were $1.2 million for the fourth quarter of 2022, compared to $4.5 million for the fourth quarter of 2021.
  • General and administrative expenses for the fourth quarter of 2022 were $2.2 million, compared to $3.0 million for the fourth quarter of 2021.
  • For the fourth quarter ended December 31, 2022, the Company reported an operating loss of $10.8 million, compared to an operating loss of $14.7 million in the fourth quarter of 2021.

Windtree Finds Cardiogenic Shock Has High Cost of US Patient Care and Plans Innovation with the Unique Profile of Istaroxime

Retrieved on: 
Monday, March 6, 2023
Cardiology, Windtree Therapeutics, Hospital, Mortality, Prevalence, Research, Cardiogenic shock, Heart, Istaroxime, SCAI, Therapy, CCU, Patient, ICU, Risk, Drug development, SBP, Length of stay, Seismology, Disease, Heart failure, Safety, NIH, Pharmaceutical industry

WARRINGTON, Pa., March 06, 2023 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, is targeting cardiogenic shock as a potential indication for its drug candidate, istaroxime and today announces results of a recently completed market study.   

Key Points: 
  • Innovative therapeutic interventions have the potential to decrease the long length of hospital stay associated with cardiogenic shock and its resulting high cost to the health care system.
  • Additionally, the resources required to take care of these patients are substantial, frequently requiring ICU or CCU care where costs are high.
  • The study revealed that 99% of US Cardiologists surveyed said there is a high need for drug treatment innovation to treat cardiogenic shock patients.
  • To the Company’s knowledge, there are no other drug candidates in clinical development for cardiogenic shock at this time.

Windtree Announces Publication on its SERCA2a Activator Drug Candidate for Chronic and Acute Heart Failure

Retrieved on: 
Tuesday, February 28, 2023
Windtree Therapeutics, Metabolite, Therapy, Arrhythmia, Journal of Pharmacology and Experimental Therapeutics, CMO, Istaroxime, Acute decompensated heart failure, Treatment, Journal, Heart failure, Probability, Activity, Relaxation, Human, Calcium, Public health genomics, Cardiogenic shock, Experiment, Pharmaceutical industry, Medical device, Pharmacology

The publication emphasizes the interest in SERCA2a as a target in treating heart failure because it is instrumental in calcium management, critically important in heart muscle contraction and relaxation.

Key Points: 
  • The publication emphasizes the interest in SERCA2a as a target in treating heart failure because it is instrumental in calcium management, critically important in heart muscle contraction and relaxation.
  • Our SERCA2a activators uniquely interfere with phospholamban, a protein that inhibits SERCA2a function and does so excessively in heart failure.
  • The preclinical data discussed in the paper provides rationale for selective targeting of SERCA2A in the treatment of heart failure.
  • “Windtree’s SERCA2a activator drug candidates could represent a promising IV or oral approach to treat heart failure,” said Steve Simonson, CMO of Windtree Therapeutics.

Windtree Therapeutics Announces Issuance of New Istaroxime Patent from U.S. Patent and Trademark Office

Retrieved on: 
Friday, February 24, 2023
Blood pressure, Windtree Therapeutics, Therapy, Heart, Istaroxime, Treatment, Diastole, 1836 U.S. Patent Office fire, AHF, Patient, Patent, Heart failure, Calcium, Cardiogenic shock, Pharmaceutical industry

Istaroxime is an investigational drug candidate being studied in early cardiogenic shock and acute heart failure.

Key Points: 
  • Istaroxime is an investigational drug candidate being studied in early cardiogenic shock and acute heart failure.
  • The claims of the newly issued patent cover longer durations of istaroxime infusion for improved outcomes in treatment of acute heart failure.
  • “Windtree continues to strengthen the patent estate for istaroxime with this new issuance from the USPTO,” said Craig Fraser, CEO and President of Windtree Therapeutics.
  • We plan to continue this work to further expand istaroxime’s patent estate in the clinical development work ahead.”

Windtree Announces Notice of Allowance from the US Patent and Trademark Office for a New Istaroxime Patent

Retrieved on: 
Tuesday, October 25, 2022
U.S. Securities and Exchange Commission, Heart rate, Therapy, Instability, Growth, Republic, Private Securities Litigation Reform Act, Patient, Calcium, Diastole, Annual report, Security (finance), Blood pressure, Istaroxime, Sarcoplasmic reticulum, Technology, Cardiogenic shock, Form 10-K, Treatment, 1836 U.S. Patent Office fire, Company, Cytoplasm, AHF, Marketing, Heart failure, Degenerative disease, Patent, Hypertension, GLOBE, USPTO, WINT, Heart, FDA, COVID-19, Pharmaceutical industry, Medical device

A notice of allowance is issued by the USPTO to indicate that the application has passed examination.

Key Points: 
  • A notice of allowance is issued by the USPTO to indicate that the application has passed examination.
  • Istaroxime is an investigational drug candidate being studied in early cardiogenic shock and acute heart failure.
  • The U.S. Patent, titled: Istaroxime-Containing Intravenous Formulation for the Treatment of Acute Heart Failure (AHF), is a continuing patent application of the expedited U.S. Track One filing by Windtree, which resulted in U.S. Patent No.
  • We are pleased with this notice of allowance for a new patent that will continue to strengthen the istaroxime patent estate, said Craig Fraser, President and Chief Executive Officer of Windtree.