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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 it has received a Bid Price Compliance Letter from The Nasdaq Stock Market LLC ("Nasdaq") informing Windtree that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market.
WINT new powerpoint presentation https://www.sec.gov/ix?doc=/Archives/edgar/data/946486/000143774924012871/wint20240423_8k.htm
Warrington-based Windtree Therapeutics is currently exploring strategic alternatives to enhance shareholder value, including the possibility of acquisitions or being acquired, writes John George for the Philadelphia Business Journal.
The company has enlisted the services of Ladenburg Thalmann & Co. Inc. to assess its options.
Despite a challenging financial landscape, Windtree has taken significant steps to bolster its financial standing. These include a lucrative licensing agreement potentially worth over $138 million and the elimination of a $15 million contingent liability.
NEWS:: 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.
DILUTION YESTERDAY ANNOUNCED AND TODAY****MIGHT DEEP FURTHER BUT WATCHLIST FOR SURE****IT IS COMING HUGE WITH TIME
cold WINT rrrrr
#riskyjoke
Windtree Therapeutics Announces the Start of Patient Dosing In Phase 2 SEISMiC Extension Study of Istaroxime in Early Cardiogenic Shock
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.
Building upon the positive SEISMiC study results, the Extension Study is expected to enroll up to 30 subjects with the objective to evaluate a longer dosing cycle of istaroxime, a novel first-in-class therapy that is designed to improve systolic contraction and diastolic relaxation of the heart while also increasing blood pressure. 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. Subjects on istaroxime will receive infusions for up to 60 hours with one istaroxime group receiving a tapered decreasing dose over time and the second istaroxime group receiving a consistent lower dose. In the previous SEISMiC study in early cardiogenic shock, patients were infused with drug or placebo for 24 hours. We believe extending the dosing duration of istaroxime has the potential to provide additional benefit and, along with dose titration, is an important factor in determining the optimal dosing regimen to study in a potential Phase 3 trial. The Extension Study will also gather data to characterize the potential benefits of SERCA2a activation in these patients, advancing the Company’s clinical and regulatory position for potential Phase 3 readiness.
The Company is also progressing the start-up of a parallel study in more severe, SCAI Stage C cardiogenic shock patients. SCAI Stage C patients have low blood pressure and inadequate blood flow to vital organs. 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. Multiple physiologic measures associated with cardiac function, blood pressure and safety will be assessed. The Company is targeting data from this study in a similar timeframe as the SEISMiC Extension Study.
“The SEISMiC Extension Study builds upon the positive data from our three Phase 2 studies in acute heart failure and early cardiogenic shock and is expected to determine the best dosing regimen for our anticipated Phase 3 program in cardiogenic shock,” said Craig Fraser, Windtree's President and Chief Executive Officer. “Along with data from more severe, SCAI Stage C cardiogenic shock patients coming from a parallel study, program results in mid-2024 are expected to contribute to finalizing our strategy and design for Phase 3 clinical trials and our end of Phase 2 discussions with FDA.”
About Istaroxime
Istaroxime is a first-in-class dual mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure demonstrate that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or the incidence of cardiac rhythm disturbances.
About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is advancing late-stage interventions for cardiovascular disorders to treat patients in moments of crisis. Using new scientific and clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with lead candidate, istaroxime, being developed as a first-in-class treatment for cardiogenic shock and acute decompensated heart failure. Windtree’s heart failure platform includes follow-on pre-clinical SERCA2a activator assets as well. In pulmonary care, Windtree has focused on facilitating the transfer of the KL4 surfactant platform, to its licensee, Lee’s Pharmaceutical (HK) Ltd. and Zhaoke Pharmaceutical (Hefei) Co. Ltd. Included in Windtree’s portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.
Windtree is actively seeking opportunities to enter into one or more strategic alliances or other strategic transactions that would support development activities for istaroxime, and the SERCA2a activators to gain regulatory and commercial market expertise as well as financial resources. For rostafuroxin, we are currently seeking an out-licensing partner.”
As a company, Windtree is open to exploring additional mergers and/or acquisitions that would complement Windtree’s areas of focus or broaden Windtree’s potential to grow its business and potentially enhance its market value for stockholders and increase our capabilities to bring important new therapies to patients in need.
Inquiries for business development should be sent to bd@windtreetx.com
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 European Patent Office has granted Patent No. 3805243, providing composition of matter patent coverage for the pure SERCA2a Activator class of drug candidates. The pure SERCA2a Activators are one of two families of preclinical drug candidates that act on SERCA2a in the Company’s pipeline. The pure SERCA2a Activators are devoid of action on the Na+/K+ pump while activating SERCA2a. The new European patent, titled: “ANDROSTANE DERIVATIVES WITH ACTIVITY AS PURE OR PREDOMINANTLY PURE STIMULATORS OF SERCA2A FOR THE TREATMENT OF Heart Failure,” provides patent protection until October 9, 2039 for the family of compounds with the pure SERCA2a mechanism of action. The other family of SERCA2a Activators is the dual mechanism of action (inhibition of the Na+/K+ pump and activation of SERCA2a) which the Company previously announced had received composition of matter patents from the European Patent Office and the U.S. Patent and Trademark Office.
The pure SERCA2a Activators have SERCA2a stimulatory activity, are intended to have oral and intravenous administration and would potentially be developed for use in the chronic out-patient heart failure market as well as the acute setting. In the U.S., approximately 6 million people (nearly 2% of the adult population) have heart failure and approximately half of these patients are expected to die within five years of diagnosis; and in the combined U.S., EU and Japan markets, there are more than 18 million patients suffering from heart failure. Heart failure is the leading cause of hospitalization in patients aged 65 years and older.
“SERCA2a activity is decreased in heart failure. Windtree believes activation of SERCA2a represents a potentially important advancement in heart failure treatment for patients,” said Craig Fraser, CEO of Windtree Therapeutics. “Heart failure with preserved ejection fraction (HFpEF) is a condition in which the heart’s main pumping chamber (left ventricle) becomes stiff and unable to fill properly. SERCA2a activation has the potential to be beneficial in this type of heart failure that accounts for nearly one-half of the chronic heart failure patients. Given the potential for oral (tablet) use, it could be utilized in both the chronic out-patient and hospital markets.”
About Pure SERCA2a Activators
These compounds activate SERCA2a without activity on the Na+/K+ pump. Windtree Therapeutic’s research program is evaluating these preclinical product candidates in heart failure.
About Dual Mechanism SERCA2a Activators
Dual Mechanism SERCA2a Activators activate SERCA2a and inhibit the Na+/K+ pump. Windtree Therapeutic’s research program is evaluating these preclinical product candidates in heart failure.
About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is advancing multiple late-stage interventions for cardiovascular disorders to treat patients in moments of crisis. Using new scientific and clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with lead candidate, istaroxime, being developed as a first-in-class treatment for acute heart failure and for early cardiogenic shock. Windtree’s pre-clinical heart failure platform includes follow-on, potentially oral, SERCA2a activator assets as well. In pulmonary care, Windtree has focused on facilitating the transfer of the KL4 surfactant platform, to its licensee, Lee’s Pharmaceutical (HK) Ltd. Included in Windtree’s portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.
10-K out ..... As of November 9, 2023, there were 5,148,219 shares of the registrant’s common stock outstanding, par value $0.001 per share.
Windtree to Present at the Sidoti Micro Cap Conference on November 16th
November 08 2023 - 08:00AM
GlobeNewswire Inc.
Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today announced that Craig Fraser, President and Chief Executive Officer, will present a corporate update at the Sidoti Micro Cap Conference on Thursday, November 16, 2023 at 1:45pm ET. Windtree management will also be participating in virtual 1x1 meetings with investors at the event on November 15 and 16.
The corporate update presentation can be viewed live by clicking on this link https://sidoti.zoom.us/webinar/register/WN_roHsRn17R5m0wQo8wOIKsQ or a recorded webcast may be accessed from the Events section of Windtree’s website at https://ir.windtreetx.com/events.
krll123
12:01 PM
$WINT To all new investors
I am a cardiologist that has done over 2 weeks of research reading all thetrial data
Read all my posts but draw your own conclusions I own 300k shares
https://stocktwits.com/krll123/message/549609340
3 conferences in 1 week. That must be a record. Kickoff starts today 12th then 17th & 19th. lets see what comes of them.
Windtree to Present at the ThinkEquity Conference on October 19th in New York City
October 12 2023 - 07:30AM
GlobeNewswire Inc.
Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today announced that Craig Fraser, President and Chief Executive Officer, will be presenting at the upcoming ThinkEquity Conference on Thursday, October 19, 2023 at 4:30pm ET. Windtree management will also be hosting 1x1 meetings with investors at the event.
The presentation will provide clinical development and business updates, including the Company’s progress on its lead product candidate istaroxime in cardiogenic shock.
Click here to register and attend the event: Click here.
About Istaroxime
Istaroxime is a first-in-class dual mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure demonstrate that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or the incidence of cardiac rhythm disturbances.
About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is advancing late-stage interventions for cardiovascular disorders to treat patients in moments of crisis. Using new scientific and clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with lead candidate, istaroxime, being developed as a first-in-class treatment for cardiogenic shock and acute decompensated heart failure. Windtree’s heart failure platform includes follow-on pre-clinical SERCA2a activator assets as well. In pulmonary care, Windtree has focused on facilitating the transfer of the KL4 surfactant platform, to its licensee, Lee’s Pharmaceutical (HK) Ltd. and Zhaoke Pharmaceutical (Hefei) Co. Ltd. Included in Windtree’s portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.
Contact Information:
Matt Epstein
mepstein@kendallir.com
MIGHT BE NEXT "WINT"
WE SHALL SEE
Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today announced that Craig Fraser, President and Chief Executive Officer, will be participating in a panel discussion titled, “Cardiac Kids: Late-Stage Advancement for Cardiovascular Disorders,” at the Lytham Partners Fall 2023 Investor Conference on Tuesday, October 17, 2023 at 10:30am ET. Windtree management will also be participating in virtual 1x1 meetings with investors at the event.
The panel discussion will include Windtree’s progress on its lead pipeline candidate istaroxime for the treatment of cardiogenic shock. The panel can be accessed on the Company’s corporate website at: Events | Windtree Therapeutics, Inc (windtreetx.com).
About Istaroxime
Istaroxime is a first-in-class dual mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure demonstrate that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or the incidence of cardiac rhythm disturbances.
About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is advancing late-stage interventions for cardiovascular disorders to treat patients in moments of crisis. Using new scientific and clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with lead candidate, istaroxime, being developed as a first-in-class treatment for cardiogenic shock and acute decompensated heart failure. Windtree’s heart failure platform includes follow-on pre-clinical SERCA2a activator assets as well. In pulmonary care, Windtree has focused on facilitating the transfer of the KL4 surfactant platform, to its licensee, Lee’s Pharmaceutical (HK) Ltd. and Zhaoke Pharmaceutical (Hefei) Co. Ltd. Included in Windtree’s portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.
Contact Information:
Matt Epstein
mepstein@kendallir.com
After Hours gapper WINT
Windtree Therapeutics Inc $1.30 $0.29 (27.10%)
Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today announced that Craig Fraser, President and Chief Executive Officer, will be presenting at the upcoming Dawson James Small Cap Growth Conference on October 12, 2023 in Jupiter, FL.
The presentation will provide clinical development and business updates including Windtree’s progress on its lead product candidate istaroxime in cardiogenic shock.
Click here to register and attend the event: Click here
About Istaroxime
Istaroxime is a first-in-class dual mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure demonstrate that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or the incidence of cardiac rhythm disturbances.
Form 4 again, another 2500 direct purchase by CEO, wonder if he knows when his company is undervalued?????
Form 4... CEO added to his pile....2,500 A $0.9 55,377 D
This was from 5 Months ago should have Phase 2 Study update Soon on Billion Dollar Drug They was going to study it at 60 hours of use on 30 patienes Should have News Coming Low Float Bio Tech trading under cash Think they captured the float like a month or 2 ago look Close at the Chart Huge Volume Back in June someone bought the entire Float
https://schrts.co/CzEZSvbw
https://ir.windtreetx.com/events
Windtree Therapeutics (NASDAQ:WINT) Is Developing A Multi-Asset Franchise Of Its Novel SERCA2a Activators In A Multi-Billion Dollar Market
https://finance.yahoo.com/news/windtree-therapeutics-nasdaq-wint-developing-130000361.html
Should have News Coming i think we will get news soon
Look at the Volume in June it was the entire Shares outstanding bought at much higher prices
This was from 5 Months ago should have Phase 2 Study update Soon on Billion Dollar Drug They was going to study it at 60 hours of use on 30 patienes Should have News Coming Low Float Bio Tech trading under cash Think they captured the float like a month or 2 ago look Close at the Chart Huge Volume Back in June someone bought the entire Float
https://schrts.co/CzEZSvbw
https://ir.windtreetx.com/events
Windtree Therapeutics (NASDAQ:WINT) Is Developing A Multi-Asset Franchise Of Its Novel SERCA2a Activators In A Multi-Billion Dollar Market
https://finance.yahoo.com/news/windtree-therapeutics-nasdaq-wint-developing-130000361.html
Should have News Coming i think we will get news soon
Look at the Volume in June it was the entire Shares outstanding bought at much higher prices
Appointment of Principal Accounting Officer
(c) Effective August 24, 2023, the Board of Directors (the “Board”) of Windtree Therapeutics, Inc. (the “Company”) appointed Jamie McAndrew as Vice President, Controller & Chief Accounting Officer. Ms. McAndrew will also act as the Company’s principal accounting officer.
Ms. McAndrew, age 43, joined the Company in November 2013 and served in various finance roles of increasing responsibility, most recently as Executive Director, Corporate Controller. Previously, Ms. McAndrew held roles of increasing responsibility at KPMG LLP from January 2008 to October 2013, at which time she served as a Manager in Transaction Services. Ms. McAndrew is a certified public accountant (currently inactive status) and received her B.A. in Philosophy and Political Science from Villanova University and her Master of Professional Accountancy from the J. Mack Robinson College of Business at Georgia State University.
In connection with Ms. McAndrew’s appointment as Vice President, Controller & Chief Accounting Officer, she will receive an annual base salary of $301,000 and an annual target bonus of 30% of her base salary.
FORM 4 CEO just bought 45,867 on the open market
Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today reported that the United States Patent and Trademark Office (USPTO) has issued US Patent No. 11,730,746 covering the Company’s dual mechanism SERCA2a Activators. The new composition of matter patent, titled: “17BETA-HETEROCYCLYL-DIGITALIS LIKE COMPOUNDS FOR THE TREATMENT OF HEART FAILURE,” provides patent protection through late 2039.
The newly issued patent follows the Company’s announcement in April 2023 that the European Patent Office granted Patent No. 3599243, which also provides patent coverage for the dual mechanism SERCA2a Activator class of drug candidates. Windtree has preclinical drug candidates with dual mechanisms of action (inhibition of the Na+/K+ pump and activation of SERCA2a) as well as pure SERCA2a activators (devoid of action on the Na+/K+ pump).
SERCA2a has been known to play a key role in heart failure and has thus been a much sought after but elusive target for several potential drug therapies. Istaroxime and these follow-on SERCA2a Activators look to deliver on the potential of SERCA2a activation in heart failure. The dual mechanism compounds activate SERCA2a and inhibit the Na+/K+ pump in a manner similar to istaroxime, which is administered intravenously (IV) and is the Company’s lead program for cardiogenic shock and acute decompensated heart failure. These new dual mechanism SERCA2a Activator product candidates are intended to be both oral and IV therapies, which could result in a hospital inpatient therapy for acute decompensated heart failure as well as an outpatient oral therapy for hospital discharge and chronic heart failure treatment.
“We are making steady progress with our IP portfolio strategy for the dual mechanism SERCA2a Activator family of drug candidates,” said Craig Fraser, Chief Executive Officer of Windtree Therapeutics. “We plan to position these new compounds as a ‘fast follow-on’ to istaroxime while offering the potential of oral bioavailability for use as a treatment for chronic heart failure. Much may be accomplished for heart failure patient treatment with this innovation.”
About Dual Mechanism SERCA2a Activators
Dual Mechanism SERCA2a Activators activate SERCA2a and inhibit the Na+/K+ pump. Windtree Therapeutic’s research program is evaluating these preclinical product candidates, including oral and intravenous SERCA2a Activator heart failure compounds.
About Istaroxime
Istaroxime is a first-in-class dual mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure demonstrate that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or the incidence of cardiac rhythm disturbances.
About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is advancing late-stage interventions for cardiovascular disorders to treat patients in moments of crisis. Using new scientific and clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with lead candidate, istaroxime, being developed as a first-in-class treatment for cardiogenic shock and acute decompensated heart failure. Windtree’s heart failure platform includes follow-on pre-clinical SERCA2a activator assets as well. In pulmonary care, Windtree has focused on facilitating the transfer of the KL4 surfactant platform, to its licensee, Lee’s Pharmaceutical (HK) Ltd. and Zhaoke Pharmaceutical (Hefei) Co. Ltd. Included in Windtree’s portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.
Stop messaging me via this ticker
Thanks
$1.38s filled !! Fire sale thanks mms
Huge spread bids in !!
Floats getting accumulated
Slight pullback for next leg up
Today's Volume 76.7KBelow Avg.
and a selloff, what does this company have to do to gain some respect? Maybe start selling AI Hoes.
News -> Windtree Therapeutics Is Developing A Multi-Asset Franchise Of Its Novel SERCA2a Activators In A Multi-Billion Dollar Market
9:05a ET 8/16/2023 - Benzinga
Sellers drying up
WINT should move to $1.95 the recent high and then to the big open gap from $2.50 to $5.50
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Discovery Laboratories, Inc., a biotechnology company, engages in developing surfactant therapies to treat respiratory disorders and diseases based on its KL4 surfactant and capillary aerosol-generating technologies. Its development stage products include Surfaxin, a synthetic, peptide-containing surfactant in phase III clinical trial for the prevention of respiratory distress syndrome in premature infants; Surfaxin LS, a Phase III trial product to improve ease of use for healthcare practitioners; and Aerosurf, an aerosolized KL4 surfactant that has completed first pilot Phase II clinical trial for the treatment of respiratory distress syndrome in premature infants.
The company has a license agreement with Philip Morris USA Inc. to use its capillary aerosolization technology for use with pulmonary surfactants for the respiratory diseases and conditions; and a strategic alliance agreement with Laboratorios del Dr. Esteve, S.A. for the development, marketing, and sale of a portfolio of potential KL4 surfactant products in Andorra, Greece, Italy, Portugal, and Spain.
Discovery Laboratories, Inc. was founded in 1992 and is headquartered in Warrington, Pennsylvania.
• | Surfaxin® (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants: The Company is conducting a comprehensive preclinical program to validate its optimized biological activity test (BAT), a key remaining issue that must be addressed to potentially gain U.S. Food and Drug Administration (FDA) marketing approval for Surfaxin in the United States. The Company has had several interactions with the FDA intended to ensure that the comprehensive preclinical program would ultimately satisfy the FDA. In January 2011, the Company announced that the FDA had provided guidance to increase the sample size of a specific data set by testing additional Surfaxin batches. To comply with the FDA's suggestion, the Company has successfully manufactured eight Surfaxin batches and presently plans to manufacture two additional Surfaxin batches for use in the comprehensive preclinical program. The Company presently plans to complete all related analytical testing and concordance studies, and be in a position to file a Surfaxin Complete Response in the third quarter of 2011. |
• | Surfaxin LSTM (lyophilized lucinactant) for neonatal RDS : The Company continues to advance this program. Its plans for 2011 include establishing a commercial-scale manufacturing capability at a cGMP-compliant contract manufacturer with expertise in lyophilized formulations and seeking regulatory guidance from the FDA and the European Medicines Agency (EMA) for the planned clinical development program. |
• | Aerosolization Technology : Recently, at the 2011 Pediatric Academic Societies Annual Meeting (PAS), new data was presented including: (i) a collaborative study indicating that aerosolized KL4 surfactant significantly improved lung function and survival when treating Acute Lung Injury in a well established preclinical model of this severe respiratory condition, (ii) a dose-ranging assessment of aerosolized KL4 surfactant in a widely recognized preclinical model of RDS, demonstrating significant improvement in lung function, lung structural integrity and pulmonary inflammatory mediator profile following treatment with aerosolized KL4 surfactant versus controls, and (iii) a study highlighting the Company's novel patient interface technology intended to increase the efficiency of pulmonary aerosol drug delivery to patients requiring positive pressure ventilatory support. |
| Regarding the Company's lead aerosolized KL4 surfactant program, Aerosurf® (aerosolized lucinactant for neonatal RDS), data from the preclinical dose ranging assessment study presented at PAS mentioned above suggests that, out of several doses tested, KL4 surfactant delivered via the Company's proprietary capillary aerosol generator during a 20 to 30 minute dosing interval results in the most favorable physiologic outcomes. This study provides guidance for future clinical dosing strategies for this program. The Company's plans for 2011 include finalizing the clinical and potential commercial design of the capillary aerosol generator, finalizing the clinical and potential commercial design for the novel patient interface, and seeking regulatory guidance in the U.S. and Europe for the planned development program. |
Investor Relations Contacts
2010-11 Press Releases
May 13, 2011 10-Q http://ih.advfn.com/p.php?pid=nmona&article=47677338
May 13, 2011 http://ih.advfn.com/p.php?pid=nmona&article=47666790 A Brighter Decade Ahead for Biotech - Equity Research on Discovery Laboratories and Mylan Inc
May 11, 2011 8k http://ih.advfn.com/p.php?pid=nmona&article=47626029
May 19, 2010
Discovery Labs Achieves Key Milestone Towards Potential Surfaxin® Approval
May 14, 2010
Discovery Labs' Phase 2a Aerosurf® Study Published in Journal of Aerosol Medicine and Pulmonary Drug Delivery
April 27, 2010
Discovery Labs Provides Updates on Surfaxin®, Other Key Programs and First Quarter 2010 Financial Results
March 10, 2010
Discovery Labs Reports Fourth Quarter 2009 Financial Results and Provides Business Update
February 23, 2010
Discovery Labs Announces Completion of $16.5 Million Public Offering
February 18, 2010
Discovery Labs Prices $16.5 Million Public Offering of Common Stock and Warrants
February 17, 2010
Discovery Labs Announces Proposed Public Offering of Common Stock and Warrants
February 16, 2010
Discovery Labs Receives FDA Guidance Regarding Pathway to Potential SURFAXIN® Approval
January 19, 2010
POPG, a Key Component of Discovery Labs KL4 Surfactant, Identified as a Novel Anti-Viral Therapeutic Approach
Management Team View Bio
W. Thomas Amick, Interim CEO
Russell Clayton, D.O.
Vice President, Academic and Medical Affairs, Acting Head, Regulatory Affairs and Preclinical Research
Kathryn Cole
Senior Vice President, Human Resources
John G. Cooper
Executive Vice President, Chief Financial Officer
David L. Lopez, C.P.A., Esq.
Executive Vice President, General Counsel
Charles F. Katzer
Senior Vice President, Manufacturing Operations
Thomas F. Miller, Ph.D., MBA
Senior Vice President, Commercialization & Corporate Development
Gerald J. Orehostky
Senior Vice President, Quality Operations
Robert Segal, M.D., F.A.C.P.
Senior Vice President, Medical & Scientific Affairs, Chief Medical Officer
Mary B. Templeton, Esq.
Senior Vice President, Deputy General Counsel
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