Beyond Air Shares Fall As US Launch Of LungFit PH Not Expected In 2021

Beyond Air Inc (NASDAQ:XAIR) expects a delay in FDA approval for LungFit PH for persistent pulmonary hypertension of the newborn.
Based on ongoing communications with the FDA, the company no longer believes that the U.S. commercial launch of LungFit PH will take place before December 31, 2021.
Beyond Air remains on track to receive CE Mark for LungFit PH in Europe in 1H 2022.
"We commend the FDA for their continued commitment to provide us with a comprehensive review of our application. We shall continue to work with the FDA to approve LungFit PH collaboratively," commented Steve Lisi, Chairman, and CEO of Beyond Air.
Related Link: Beyond Air Reports Interim Data Of Self-Administered Inhaled NO For Lung Disease.
Price Action: XAIR shares traded lower by 23.2% at $8.15 during the market session on the last check Thursday.