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Last $0.82 USD
Change Today +0.0015 / 0.18%
Volume 21.3K
DSCO On Other Exchanges
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As of 10:07 AM 05/27/15 All times are local (Market data is delayed by at least 15 minutes).

discovery laboratories inc (DSCO) Key Developments

Discovery Labs Announces Enrollment of First Patient in AEROSURF® Phase 2A Dose Expansion Trial

Discovery Laboratories Inc. reported that the first patient has been enrolled in the next phase of its phase 2a clinical evaluation of AEROSURF®, which is designed to evaluate the safety and tolerability of higher and repeat doses of aerosolized KL4 surfactant administered to premature infants 29 to 34 weeks gestational age (GA) who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to infants receiving nCPAP alone. This phase is intended to expand upon the knowledge gained in the recently completed phase 2a clinical trial, the results of which were reported in mid-May 2015. The Company expects to complete this study in the fourth quarter of 2015. The recently completed phase 2a clinical trial was designed to assess the safety and tolerability of three escalating single doses of aerosolized KL4 surfactant in premature infants 29 to 34 weeks gestational age who are receiving nCPAP for RDS, compared to infants receiving nCPAP alone. All key objectives were achieved, including the primary objective of demonstrating a favorable safety and tolerability profile of AEROSURF, establishing proof of concept for the Company's proprietary technology platform based on physiological data suggesting that aerosolized KL4 surfactant is being delivered into the lung of premature infants, and acceptable performance of the novel capillary aerosol generator (CAG) technology in the neonatal intensive care unit (NICU). This next phase 2a dose expansion study is a multicenter, randomized, open-label, controlled study and is designed to evaluate the safety and tolerability of aerosolized KL4 surfactant administered in higher and repeat doses in premature infants 29 to 34 weeks GA who are receiving nCPAP for RDS, compared to infants receiving nCPAP alone. In addition to safety and tolerability, another objective of the expansion study is to continue to evaluate the physiological effects of higher and repeat dosing of aerosolized KL4 surfactant. The results of this expansion trial are expected to provide further insight and data to support the design of the planned AEROSURF phase 2b clinical program.

Discovery Laboratories Inc. Reports Top Line Data from AEROSURF® Phase 2A Clinical Trial

Discovery Laboratories Inc. reported top line data from its recently completed AEROSURF® phase 2a clinical trial in premature infants with respiratory distress syndrome. Key objectives of the study were achieved, including (1) the primary objective of demonstrating the safety and tolerability of a single exposure of aerosolized KL4 surfactant administered in three escalating inhaled doses to premature infants 29 to 34 week gestational age and receiving nasal continuous positive airway pressure (nCPAP) for RDS, compared to infants receiving nCPAP alone, and (2) establishing proof of concept for the Company's proprietary technology platform based on physiological data suggesting that aerosolized KL4 surfactant is being delivered into the lung of premature infants, and acceptable performance of the novel capillary aerosol generator (CAG) technology in the neonatal intensive care unit (NICU). AEROSURF is Discovery Labs' combination drug/device product that combines the Company's novel synthetic peptide-containing (KL4) surfactant and its proprietary aerosol delivery technologies, including the CAG, that are designed to enable efficient delivery of aerosolized KL4 surfactant. Currently, the available surfactants (animal-derived) can only be administered using endotracheal intubation with mechanical ventilation, invasive procedures that may each result in serious complications and other respiratory conditions. With AEROSURF, neonatologists potentially will be able to administer aerosolized KL4 surfactant to premature infants supported with nCPAP alone, without having to resort to invasive intubation and mechanical ventilation.

Discovery Laboratories Inc. - Special Call

To discuss results from its AEROSURF Phase 2a clinical trial

Discovery Laboratories Inc. Announces Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2015

Discovery Laboratories Inc. announced unaudited consolidated earnings results for the first quarter ended March 31, 2015. For the quarter, the company reported net revenues were $191,000 against $31,000 a year ago. Operating loss was $11,173,000 against $10,763,000 a year ago. Net loss was $12,179,000 against $11,476,000 a year ago. Net loss per share was $0.14 against $0.14 a year ago. Net cash outflows for the quarter ended March 31, 2015 were $9.1 million.

Discovery Laboratories, Inc. Completes Enrollment of AEROSURF Phase 2a Clinical Trial and Restructures

Discovery Laboratories Inc. announced that it has completed enrollment in its AEROSURF phase 2a clinical trial assessing the administration of a single dose of AEROSURF in premature infants 29-34 week gestational age (GA) with respiratory distress syndrome (RDS). The company also is implementing a restructuring plan to voluntarily cease the commercialization of SURFAXIN (lucinactant) Intratracheal Suspension and focus its resources on the development of its aerosolized KL4 surfactant for respiratory diseases, beginning with AEROSURF. AEROSURF: The AEROSURF phase 2a trial is a multi-center, open-label trial to evaluate safety and tolerability of a single dose of aerosolized KL4 surfactant in premature infants (n = 48) 29 to 34 weeks GA who are receiving nasal continuous positive airway pressure (nCPAP) for RDS, compared to infants receiving nCPAP alone. The study evaluated three escalating doses of AEROSURF. In addition to evaluating safety and tolerability, another key objective is to establish proof of concept for the company's proprietary technology platform with (1) physiological data indicating that aerosolized KL4 surfactant is being effectively delivered into the lung of premature infants, and (2) acceptable performance by the novel capillary aerosol generator (CAG) technology in the neonatal intensive care unit (NICU). The company anticipates releasing the results of this trial and holding an investor conference call in approximately three to four weeks. AEROSURF is the company's investigational combination drug/device product that combines its synthetic KL4 surfactant with its proprietary CAG. If AEROSURF is successfully developed and approved, neonatologists will be able to administer aerosolized KL4 surfactant to premature infants receiving nCPAP, without having to use invasive methods (intubation and mechanical ventilation procedures that may each result in serious respiratory conditions and other complications) that currently are required to administer all surfactants. AEROSURF potentially will address this unmet medical need and may make possible the treatment of a significantly greater number of premature infants with RDS who could benefit from surfactant therapy but are currently not treated.

 

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