Proactive Investors - Run By Investors For Investors

Circassia Pharmaceuticals says partner AIT Therapeutics successfully completes FDA pre-submission meeting

The group said AIT anticipates submitting a Premarket Approval application for AirNOvent in the second quarter of 2019 for use in the treatment of hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn
Circassia Pharmaceuticals says partner AIT Therapeutics successfully completes FDA pre-submission meeting
Circassia said it anticipates launching the product in the first half of 2020, once approved

Circassia Pharmaceuticals PLC (LON:CIR) revealed that its partner, AIT Therapeutics Inc. has successfully completed a pre-submission meeting with the US FDA for the ventilator-compatible nitric oxide product AirNOvent.

The AIM-listed specialty pharmaceutical company, which is focused on respiratory disease, said AIT anticipates submitting a Premarket Approval application (PMA) for AirNOvent in the second quarter of 2019 for use in the treatment of hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn (PPHN).

WATCH: Circassia's AirNOvent drug a step closer to market with FDA pre-submission meeting

Circassia said it anticipates launching the product in the first half of 2020, once approved.

The group announced on 24 January 2019 that it had entered a definitive agreement to acquire the exclusive commercialisation rights to AirNOvent in the United States and China from AIT. 

Under the agreement, the successful completion of the FDA meeting triggers a milestone payment of US$3.15mln, which Circassia said it intends to satisfy through the issuance of new ordinary shares in the company to AIT.

Steve Harris, Circassia's CEO, commented: "Successful completion of this pre-submission meeting represents a further key milestone in advancing AirNOvent towards the market. 

“We are excited at the potential benefits offered by AirNOvent, once approved, and look forward to AIT submitting this novel nitric oxide product for regulatory approval in the coming months."

View full CIR profile View Profile

Circassia Pharmaceuticals Timeline

Related Articles

scientist in laboratory
May 24 2019
Here we take a closer look at healthcare investor NetScientific PLC (LON:NSCI)
lung x-ray
May 07 2019
The company has been developing a treatment for chronic lung disease in-house and has partnered with an Australian group to develop a drug for rare liver and lung complaints
dna strand
May 08 2019
The latest update reveals the company significant clinical and commercial milestones in sight
Copyright © Proactiveinvestors.com, 2019. All Rights Reserved - Proactive Investors North America Inc., Proactive Investors LLC

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use