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August 5, 2014
08:18 EDTDSCODiscovery Labs reports Q2 EPS (12c), consensus (15c)
Reports Q2 revenue $1.09M, consensus $580.000. Included in the EPS net loss is the change in fair value of certain common stock warrants that are classified as derivative liabilities, resulting in non-cash income of $1.4M.
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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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