Business
Liquidia Reports First Quarter 2020 Financial Results and Provides Corporate Update
Received FDA Acceptance of LIQ861 NDA for ReviewReported Final Safety and Tolerability Results for LIQ861 Inspire TrialManagement to Host Webcast and
About this update from Liquidia Corporation
[{"type":"text","content":"Received FDA Acceptance of LIQ861 NDA for ReviewReported Final Safety and Tolerability Results for LIQ861 Inspire TrialManagement to Host Webcast and Conference Call Today at 4:30p.m. ET\n RESEARCH TRIANGLE PARK, N.C., May 11, 2020 (GLOBE NEWSWIRE) -- Liquidia Technologies, Inc. (Nasdaq:LQDA), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products using its proprietary PRINT® technology, today reported financial results for the first quarter ended March 31, 2020 and provided a corporate update. \"FDA acceptance of the LIQ861 NDA for review is a significant milestone and a testament to the progress we have made as a company, including our ability to harness the power of our PRINT technology to advance our product candidates through clinical development,” said Neal Fowler, Chief Executive Officer of Liquidia. “If approved, LIQ861 represents an important step forward for patients in need of additional treatment options and will serve as the gateway for Liquidia to achieve its goal of becoming a fully integrated, commercial organization. I am proud of the progress we have made as a company on all fronts, even in the face of a global crisis, and remain confident in our approach toward our 2020 objectives.” Corporate Update Received FDA acceptance of LIQ861 NDA for regulatory reviewIn January 2020, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for LIQ861, the Company’s lead product candidate, as a potential treatment for patients with pulmonary arterial hypertension (PAH). In April 2020, the FDA accepted the NDA for review and provided a Prescription Drug User Fee Act (PDUFA) goal date of November 24, 2020. Liquidia is developing LIQ861 under the 505(b)(2) regulatory pathway with Tyvaso® as the reference listed drug, which allows Liquidia to rely in part on the FDA’s previous findings of efficacy and safety of Tyvaso and the active ingredient treprostinil, which has been approved in four different products administered through the oral, inhaled and continuous infusion (parenteral) routes.Reported final LIQ861 safety and tolerability results from pivotal INSPIRE trialIn April 2020, the Company reported final safety and tolerability results from the two-month endpoint of the open-label phase 3 trial, INSPIRE, or Investigation ...