Please wait while we load the requested 10-Q report or click the link below:
Liquidia Technologies, Inc.
419 Davis Drive, Suite 100
Morrisville, NC 27560
Liquidia Reports Second Quarter 2020 Financial Results and Provides Corporate Update
FDA Acceptance of LIQ861 NDA for Review
Reported Final Safety and Tolerability Results for LIQ861 INSPIRE Trial
Appointed Tushar Shah, M.D. as Chief Medical Officer
Announced Definitive Agreement to Acquire RareGen, LLC
Completed Public Offering of Common Stock
Company to Host Webcast and Conference Call Today at 4:30p.m. ET
RESEARCH TRIANGLE PARK, N.C., August 10, 2020 - 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 second quarter ended June 30, 2020 and provided a corporate update.
“The second quarter of 2020 was marked by progress as we continued to execute effectively against key milestones that strengthen our position for the launch of LIQ861 and the future value of our company,” said Neal Fowler, Chief Executive Officer of Liquidia. “The proposed acquisition of RareGen would be significant as it would provide Liquidia with a relevant sales force and, importantly, would bolster Liquidia’s ability to advance much needed treatment options for the PAH community. Combined with the closing of a $75 million public offering and the appointment of Tushar Shah, M.D. as Chief Medical Officer, I am confident that we have the resources and talent required to advance our mission as a company.”
|·||Received FDA acceptance of LIQ861 NDA for regulatory review|
In April 2020, the U.S. Food and Drug Administration (FDA) accepted Liquidia’s New Drug Application (NDA) for LIQ861, the Company’s lead product candidate as a potential treatment for patients with pulmonary arterial hypertension (PAH), for review and provided a Prescription Drug User Fee Act (PDUFA) goal date of November 24, 2020. LIQ861 is an investigational, inhaled dry powder formulation of treprostinil designed and engineered using Liquidia’s novel PRINT technology with the goal of enhancing deep-lung delivery of treprostinil in PAH patients by means of a convenient, palm-sized dry powder inhaler.
|·||Reported final LIQ861 safety and tolerability results from pivotal INSPIRE trial|
In 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 of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, for LIQ861. Of the 121 PAH patients, 113, or 93 percent, completed their two-month visit. The most common reported treatment-emergent adverse events (TEAEs) (reported in ≥ four percent) were cough (42 percent), headache (26 percent), throat irritation (16 percent), dizziness (11 percent), diarrhea (9 percent), chest discomfort (8 percent), nausea (7 percent), dyspnea (5 percent), flushing (5 percent) and oropharyngeal pain (4 percent). These final primary endpoint findings are consistent with the safety and tolerability results previously reported.
The following information was filed by Liquidia Technologies Inc (LQDA) on Monday, August 10, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
View differences made from one quarter to another to evaluate Liquidia Technologies Inc's financial trajectory
Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were
removed , and by Liquidia Technologies Inc.