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Liquidia Reports Fourth Quarter and Full-Year 2019 Financial Results and Provides Corporate Update
Submitted New Drug Application (NDA) for LIQ861 in January 2020 Management to Host Webcast and Conference Call Today at 8:00 a.m. ET RESEARCH TRIANGLE PARK,
About this update from Liquidia Corporation
[{"type":"text","content":"Submitted New Drug Application (NDA) for LIQ861 in January 2020 Management to Host Webcast and Conference Call Today at 8:00 a.m. ET\n RESEARCH TRIANGLE PARK, N.C., March 11, 2020 (GLOBE NEWSWIRE) -- Liquidia Technologies, Inc. (Nasdaq: LQDA) (“Liquidia” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products utilizing its proprietary PRINT® technology, today reported financial results for the fourth quarter and full-year ended December 31, 2019, and provided a corporate update. “We are pleased to have submitted our NDA for LIQ861, an important milestone in our continued evolution towards becoming a fully-integrated, commercial biopharmaceutical company. We were also pleased to raise additional equity capital through a private placement and ATM sales during the fourth quarter. We look forward to continuing to advance our pipeline based upon our PRINT technology to bring meaningful benefits to patients,” stated Neal Fowler, Liquidia’s Chief Executive Officer. Corporate Update Completed INSPIRE clinical trial and submitted NDA for LIQ861Based upon the favorable results of the pivotal Phase 3 INSPIRE trial and pharmacokinetic studies in healthy volunteers, the Company submitted an NDA for LIQ861 to the U.S. Food and Drug Administration (FDA) on January 24, 2020 under the 505(b)(2) regulatory pathway. As previously reported, the safety and tolerability profile of LIQ861, the primary endpoint of the INSPIRE trial, was observed to be favorable. Also, as previously reported, a high rate of sustained treatment benefit across certain exploratory endpoints was observed, including the maintenance or improvement of New York Heart Association (NYHA) functional class in more than 90% of all patients enrolled in the trial who completed two months of treatment. As recently reported at the 14th Annual Pulmonary Vascular Research Institute (PVRI) Conference, results of a pharmacokinetic study in healthy volunteers have also demonstrated that treprostinil exposure from a 79.5 mcg dose of LIQ861 is comparable to that of nine breaths of Tyvaso, the reference listed drug.Continuing clinical studies to evaluate long-term safety, tolerability and hemodynamic effects of LIQ861Most patients from INSPIRE continue to receive LIQ861 in the extension study, including several patien...