XAIR - Beyond Air says U.S. launch of LungFit system unlikely before year-end

Beyond Air (XAIR -22.9%) shares have approached the lowest level since mid-August after the company cited its ongoing discussions with the FDA to indicate that its U.S. commercial launch of LungFit PH is unlikely to happen before Dec. 31, 2021. However, Beyond Air (NASDAQ:XAIR) reiterated its timeline to receive the CE Mark for LungFit PH in Europe in H1 2022. A generator and delivery system of nitric oxide, LungFit PH, is designed as a potential therapy for pulmonary hypertension of the newborn. “We commend the FDA for their continued commitment to provide us with a comprehensive review of our application. We shall continue to collaboratively work with the FDA to approve LungFit® PH,” CEO Steve Lisi remarked.

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Beyond Air says U.S. launch of LungFit system unlikely before year-end