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

  • Beyond Air Inc 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.
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