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February 13, 2013
16:13 EDTDSCODiscovery Labs receives $30M investment from Deerfield
Deerfield Management announced that it has entered into a secured loan facility with Discovery Laboratories for up to $30M in financing. The financing provides Discovery with capital to commercialize its drug Surfaxin, which has been approved by the FDA for the prevention of Respiratory Distress Syndrome, or RDS, in premature infants at high risk for RDS, and its Afectair airway connector for infants receiving aerosolized medication in neonatal or pediatric intensive care units. The launch of these products will enable Discovery to transition from a development- to a commercial-stage company, and further develop its lead pipeline product, Aerosurf. The financing was structured to provide funding over time as needed and to avoid the dilution and potential discount of a public offering of stock or convertible debt financing. Under terms of the facility, Deerfield committed to advance $30M this year
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February 1, 2016
16:05 EDTDSCODiscovery Labs initiates AEROSURF phase 2b clinical trial
Discovery Labs said that based on the safety and tolerability profile observed to date in the phase 2a clinical program, the company has initiated the AEROSURF phase 2b clinical trial in premature infants 26 to 32 week gestational age receiving nasal continuous positive airway pressure for respiratory distress syndrome. The trial is a multicenter, randomized, controlled study with masked treatment assignment in approximately 240 premature infants and is designed to evaluate the safety and tolerability of aerosolized KL4 surfactant administered in two dose groups, compared to infants receiving nCPAP alone. The following endpoints will be evaluated: time to nCPAP failure, incidence of nCPAP failure and physiological parameters indicating the effectiveness of lung function. The trial is expected to be conducted in up to 60 clinical sites in the United States, Canada, Europe and Latin America. Enrollment is beginning with premature infants 29 to 32 weeks GA, and will include premature infants 26 to 28 weeks GA after completion of the ongoing phase 2a clinical trial in this age group. The xompany anticipates completing enrollment for the phase 2b clinical trial by the end of 2016 and releasing top-line results in the first quarter of 2017. As of December 31, 2015, the xompany had cash and cash equivalents of $38.7M, an amount it anticipates is sufficient to support the AEROSURF phase 2 clinical program and fund operations through Q1 of 2017.
16:03 EDTDSCODiscovery Labs announces resignation of CEO John Cooper
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