Beyond Air's LungFit PH Gets FDA Approval, Stock Jumps 25%

(RTTNews) - Shares of Beyond Air, Inc. (XAIR) are gaining over 25% in extended trading session on Tuesday after the company said its LungFit PH has received FDA approval to treat term and near-term neonates with hypoxic respiratory failure.

XAIR closed Tuesday's trading at $5.78, down $0.49 or 7.81%, on the Nasdaq. The stock, however, gained $1.47 or 25.43%, in the after-hours trading.

Beyond Air is 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.

The company announced FDA that the U.S. Food and Drug Administration has approved LungFit PH to treat term and near-term neonates with hypoxic respiratory failure, often referred to as persistent pulmonary hypertension of the newborn or PPHN. LungFit PH is the initial device from the LungFit therapeutic platform of nitric oxide generators that use our patented Ionizer technology and is the first FDA-approved product for Beyond Air.

Steve Lisi, Chairman and CEO of Beyond Air, commented, "The FDA approval of LungFit PH enables a new era of nitric oxide therapy and marks a pivotal event for Beyond Air as we officially enter the U.S. market. As the first and only approved nitric oxide generator and delivery system, LungFit PH empowers healthcare providers to maximize the efficiency of a hospital when treating PPHN by moving beyond their reliance on traditional, inefficient delivery systems and the associated burdensome logistics and safety requirements."