Windtree Therapeutics, Inc., a clinical-stage biotechnology and medical device company, focuses on the development of therapeutics for the treatment of acute pulmonary and cardiovascular diseases. Its lead development programs include istaroxime, which is in Phase 2b clinical trial for the treatment of acute decompensated heart failure, as well as in Phase 2a clinical trial for the treatment of early cardiogenic shock; AEROSURF, an aerosolized KL4 surfactant, which is in Phase 2b clinical trial to treat respiratory distress syndrome (RDS) in premature infants; lyophilized KL4 surfactant for the treatment of lung injury resulting from COVID-19; and Rostafuroxin that is in Phase 2b clinical trial for the treatment of genetically associated hypertension. The company has a collaboration with University of Milan-Bicocca for the discovery and development of new SERCA2a compounds for the treatment of chronic and acute human heart failure. The company was formerly known as Discovery Laboratories, Inc. and changed its name to Windtree Therapeutics, Inc. in April 2016. Windtree Therapeutics, Inc. was incorporated in 1992 and is headquartered in Warrington, Pennsylvania. Windtree Therapeutics, Inc. operates as a subsidiary of Lee's Pharmaceutical Holdings Limited.
IPO Year:
Exchange: NASDAQ
Website: windtreetx.com
WARRINGTON, Pa., May 06, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or the "Company") (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating company and advancing early and late-stage innovative therapies for critical conditions and diseases, is pleased to announce it has received advice from intellectual property and FDA experts highlighting a U.S. strategy that can provide 7.5 years of U.S. exclusivity for istaroxime if it is approved by the FDA in cardiogenic shock. Specifically, as a never-before-approved active ingredient, istaroxime may receive New Chemical Entity (NCE) designation from the FDA. If the new drug application is approved
WARRINGTON, Pa., May 01, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or the "Company") (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating company and advancing early and late-stage innovative therapies for critical conditions and diseases, is pleased to announce that it has entered an Assignment and Conditional Assumption Agreement with a seasoned real estate investment group pursuant to which it has gained the rights to purchase a 436 unit, multifamily residential property in Houston, Texas. The property is expected to contribute consistent rental revenue to the Company while it continues to develop its therapeutic pipeline. The planned
WARRINGTON, Pa., April 15, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or "the Company") (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions, today reported financial results for the fiscal year ended December 31, 2024 and provided key business updates. "The year 2024 saw Windtree make great progress in many key areas including clinical development of our lead drug candidate istaroxime in cardiogenic shock, business development and the future strategy of the Company," said Jed Latkin, CEO of Windtree. "Cardiogenic shock is a critical condition with high morbidity and mortality where clinician
-- Evofem's Cost to Manufacture PHEXXI will Decrease by 55% - 60% -- SAN DIEGO, March 26, 2025 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB:EVFM) (Evofem or the Company) today announced that it has entered into a License and Supply Agreement (L&S Agreement) with Windtree Therapeutics, Inc. (NasdaqCM: WINT), under which Windtree will be Evofem's sourcing partner for PHEXXI® (lactic acid, citric acid and potassium bitartrate). This FDA-approved hormone-free contraceptive vaginal gel is applied 0 to 60 minutes before each act of intercourse. It prevents pregnancy by maintaining the normal vaginal biome which has a slightly acidic pH that is inhospitable to sperm.
-- 2024 Net Sales Increased 6% to $19.4 Million -- -- Total Operating Expense Reduced 27% from 2023 Levels, Excluding Non-cash Amortization Expense -- -- Sales and Marketing Expense as a Percentage of Net Sales was 47% for 2024 and 31% for the Fourth Quarter, the Most Favorable Ratios since the PHEXXI Launch -- SAN DIEGO, March 24, 2025 /PRNewswire/ -- Women's health innovator Evofem Biosciences, Inc. (OTCQB:EVFM), today announced financial results for the fourth quarter and year ended December 31, 2024. Highlights include: EVFM) (PRNewsfoto/Evofem Biosciences, Inc.)" alt="Women's health innovator Evofem Biosciences (OTCQB:E
WARRINGTON, Pa., March 24, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or the "Company") (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating biotech and advancing early and late-stage innovative therapies for critical conditions and diseases, today announced that the Company received notice from The Nasdaq Stock Market LLC ("Nasdaq") that Windtree has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on Nasdaq. The Company will be subject to a mandatory panel monitor until March 20, 2026. The Company was previously notified by Nasdaq on December 4, 2024 that it was not i
WARRINGTON, Pa., March 20, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or the "Company") (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating biotech and advancing early and late-stage innovative therapies for critical conditions and diseases, is pleased to announce that it has entered into a License and Supply Agreement to become the sourcing partner for Evofem Biosciences, Inc. (OTCQB:EVFM) for one of Evofem's FDA-approved products -- PHEXXI® (lactic acid, citric acid and potassium bitartrate). The product is a first-in-class hormone-free, on-demand prescription contraceptive vaginal gel that women control. PHEXXI annual revenues have gr
WARRINGTON, Pa., March 04, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or the "Company") (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, is pleased to announce that the United States Patent and Trademark Office has issued a Notice of Allowance for U.S. application number 18/150,870 directed to "ISTAROXIME-CONTAINING INTRAVENOUS FORMULATION FOR THE TREATMENT OF ACUTE HEART FAILURE." "Acute heart failure, or AHF, impacts millions of patients around the world and its cost to healthcare systems is significant," said Jed Latkin, CEO of Windtree. "We believe that drug innovation i
WARRINGTON, Pa., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or the "Company") (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, announced today that the Company has filed a national phase patent application with the Indian patent office claiming priority to PCT/US2024/058923 entitled, "ISTAROXIME AND DERIVATIVES THEREOF FOR PREVENTING OR REDUCING THE RISK OF ACUTE MYOCARDIAL ARRHYTHMIA." Arrythmias are irregular heartbeats that can impact the pumping function of the heart. Patients with heart failure and cardiomyopathy are at risk for arrythmias. Arrythmias in thes
WARRINGTON, Pa., Feb. 18, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NasdaqCM: WINT) ("Windtree" or the "Company"), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, announces that its board of directors has approved a 1-for-50 reverse stock split of the Company's common stock. The Company's stockholders approved the reverse stock split proposal at the Company's Special Meeting of Stockholders held on February 3, 2025. The stockholders granted the board of directors the authority to determine the exact split ratio and when to proceed with the reverse stock split. The reverse stock split will become effec
Oppenheimer initiated coverage of Windtree Therapeutics with a rating of Outperform and set a new price target of $8.00
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WARRINGTON, Pa., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or the "Company") (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced the appointment of Leanne Kelly to its board of directors ("Board"). Ms. Kelly has significant public company executive experience and joins the Board as an independent director and chair of the audit committee. Ms. Kelly has served as GRI Bio's Chief Financial Officer since April 2023. She brings over 20 years of experience leading private and publicly traded companies across life science, technology and e-Commerce sectors w
WARRINGTON, Pa., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or the "Company") (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced that Craig Fraser plans to retire from his role as Chief Executive Officer, effective December 1, 2024, after nearly nine years of distinguished service to the Company. Mr. Fraser will remain on the Board of Directors of the Company as Chairman. The Company's Board has appointed Jed Latkin, a current director of the Company, to replace Mr. Fraser as CEO and Mr. Latkin will also remain a member of the Board. Mr. Fraser has ser
WARRINGTON, Pa., Aug. 20, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or the "Company") (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions, today reported financial results for the second quarter ended June 30, 2024 and provided key business updates. "The second quarter of 2024 was marked with significant progress with our lead asset, istaroxime in development for the treatment of cardiogenic shock. We expect the istaroxime Phase 2 SEISMiC Extension study to complete enrollment in the next few weeks and we plan to report topline data by the end of the third quarter of 2024. We are also sup
WARRINGTON, Pa., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or the "Company") (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced changes to its board of directors, effective August 13, 2024, which include the appointment of Saundra Pelletier and Jed Latkin as two new independent directors with significant public company director and executive leadership. Joining the Windtree board is Saundra Pelletier, who has served as the Interim Chair since late 2021 and as Chief Executive Officer, President and Executive Director since early 2015 of Evofem Bioscien
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. Dr. Strobeck has more than 20 years of experience in operations, business development, capital raising and M&A and has a track record of success creating and building value for emerging and public biotechnology and life sciences companies. Currently, Dr. Strobeck is President and CEO, and a Member of the Board, at Rockwell Medical, a publicly held healthcare company that devel
WARRINGTON, Pa., July 1, 2021 /PRNewswire/ -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology and medical device company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today announced the appointment of Diane Carman, Esq. as Senior Vice President and General Counsel, reporting to Craig Fraser, President and Chief Executive Officer. Ms. Carman brings over two decades of successful experience working in the life sciences and other highly regulated industries. She has built the legal and compliance infrastruc
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WARRINGTON, Pa., April 15, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or "the Company") (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions, today reported financial results for the fiscal year ended December 31, 2024 and provided key business updates. "The year 2024 saw Windtree make great progress in many key areas including clinical development of our lead drug candidate istaroxime in cardiogenic shock, business development and the future strategy of the Company," said Jed Latkin, CEO of Windtree. "Cardiogenic shock is a critical condition with high morbidity and mortality where clinician
-- 2024 Net Sales Increased 6% to $19.4 Million -- -- Total Operating Expense Reduced 27% from 2023 Levels, Excluding Non-cash Amortization Expense -- -- Sales and Marketing Expense as a Percentage of Net Sales was 47% for 2024 and 31% for the Fourth Quarter, the Most Favorable Ratios since the PHEXXI Launch -- SAN DIEGO, March 24, 2025 /PRNewswire/ -- Women's health innovator Evofem Biosciences, Inc. (OTCQB:EVFM), today announced financial results for the fourth quarter and year ended December 31, 2024. Highlights include: EVFM) (PRNewsfoto/Evofem Biosciences, Inc.)" alt="Women's health innovator Evofem Biosciences (OTCQB:E
WARRINGTON, Pa., Nov. 27, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or "the Company") (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions, today reported financial results for the third quarter ended September 30, 2024 and provided key business updates. "The third quarter of 2024 was marked with significant progress. We were very pleased with the SEISMiC B study results in early cardiogenic shock showing significant improvement in many measures of cardiac function and blood pressure along with a favorable safety profile in patients with heart failure and cardiogenic shock. There have been
WARRINGTON, Pa., April 08, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or the "Company") (NasdaqCM: WINT), today announced that on April 2, 2024 the Company entered into an asset purchase agreement with Varian Biopharmaceuticals, Inc. ("Varian") to acquire certain of its assets, including a proprietary atypical protein kinase C iota inhibitor (aPKCi). The Company also completed a $1.5 million convertible note bridge financing. The acquired Varian asset platform is a novel, potential high-potency, specific, aPKCi with possible broad use in oncology as well as certain rare malignant diseases. The asset platform includes two formulations: VAR-101 (topical) and VAR-102 (o
The study met its primary endpoint of improved systolic blood pressure (SBP) profile at 6 hours with the istaroxime group performing significantly better than the control group Increased SBP also persisted through 24 hours The study also met several key secondary endpoints associated with improving cardiac function Investor conference call and webcast to be held today, Monday May 23 at 4:30 pm EDT WARRINGTON, Pa., May 23, 2022 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today presented data from its positive Phase 2 study of istaroxim
WARRINGTON, Pa., May 16, 2022 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today announced management will host a conference call and webcast to discuss its istaroxime Phase 2 study in early cardiogenic shock patients following the late-breaker presentation of the data at the European Society of Cardiology Heart Failure Meeting in Madrid, Spain on May 23, 2022. The Company previously announced a positive topline result from the trial and explained that further details were under embargo due to the acceptance of the late-breaker presentation
WARRINGTON, Pa., April 20, 2022 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today announced a late-breaker presentation at the upcoming European Society of Cardiology Heart Failure Conference taking place on May 21-24, 2022 in Madrid, Spain. Late-Breaking Science sessions are innovative and provide the latest breakthroughs in clinical science. These sessions provide notable exposure and recognition for studies likely to have a significant impact on clinical practice and/or to make significant advances in a scientific field. The presentatio