Beyond Air's quarterly sales rise 28% to $2.3m while transport-use label awaits FDA

Beyond Air, the US maker of the LungFit nitric oxide platform, booked $2.3m of revenue in the quarter to 30 September 2026, about 28% more than in the same period of 2025. The company announced the figure on 11 November and described it as its highest quarterly total to date. Net loss for the three months was $7.8m, more than three times the sales line.

The regulatory question is whether the second-generation LungFit PH will be cleared for use in air and ground transport. Beyond Air has filed a premarket approval supplement asking the US Food and Drug Administration to extend the device's labelling to cover those settings, and the file is still under review. The company expects to be ready for an audit in mid-December, after which the agency is due to carry out inspections. No decision date has been disclosed.

Management kept its sales outlook unchanged at $8m for 2026 and $16m to $18m for 2027. The 2027 range is roughly double the current-year target. Whether it holds will be tested against uptake of the existing product and the outcome of the transport-labelling review, though the company has not said how much of the projection depends on that label.

Beyond Air also said its LungFit GO system has received Breakthrough Device Designation for nontuberculous mycobacterial pulmonary disease, and that it has agreed to sell its controlling interest in NeuroNOS. The information available gave no financial terms for the NeuroNOS transaction or a buyer.