Liquidia Files for FDA Approval for Hypertension Therapy

Morrisville-based Liquidia Technologies has filed a New Drug Application with the U.S. Food and Drug Administration for LIQ861, an inhaled dry powder to treat patients with pulmonary arterial hypertension (PAH).

It is designed to administer higher dose levels than current inhaled therapies by using a convenient, palm-sized, disposable dry powder inhaler. 

The FDA submission comes after three clinical studies established the treatment’s safety, tolerability and pharmacokinetic profile.

“The submission of the NDA for LIQ861 in the U.S. is a significant milestone for our company and our goal to address an important unmet need in the delivery of inhaled therapy for PAH patients,” said Neal Fowler, Liquidia’s CEO, in a statement.

“We would like to sincerely thank the patients, their families and the clinical investigators for their participation in the LIQ861 clinical program, and we look forward to working closely with the FDA during the review process.”

Liquidia landed $22.4 million in December through a common stock purchase agreement with certain institutional accredited investors for the private placement of 7,164,534 shares of common stock at $3.13 per share.

In addition to LIQ861, Liquidia is also developing LIQ865 to treat post-operative pain. Both therapies are based on the company's proprietary PRINT particle engineering technology.