Beyond Air, Inc. (XAIR) Reports In-Line Q1 EPS, Revenues Beat

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Beyond Air, Inc. (XAIR) Submits Premarket Approval Application to FDA for LungFit PH to Treat Persistent Pulmonary Hypertension of the Newborn

November 11, 2020 7:31 AM EST

Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, today announced the submission of a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its LungFit PH to treat persistent pulmonary hypertension of the newborn (PPHN). FDA guidelines allow for a 180-day review period for a PMA.

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