By Michael Dabaie

Beyond Air Inc. shares were up 8.7% to $6.29 after getting FDA approval for its LungFit PH product in neonates with hypoxic respiratory failure.

The company focused on developing inhaled nitric oxide for treatment of patients with respiratory conditions, after the bell Tuesday said the U.S. Food and Drug Administration approved LungFit PH to treat term and near-term neonates with hypoxic respiratory failure. Hypoxic respiratory failure is often referred to as persistent pulmonary hypertension of the newborn.

LungFit PH is the initial device from the LungFit therapeutic platform of nitric oxide generators that use Ionizer technology and is the first FDA-approved product for Beyond Air.

Truist analyst Gregory D. Fraser said the LungFit PH has the potential to be disruptive in the $400 million nitric oxide market and raised its price target to $20 from $16 on the approval. "We see significant upside for the stock as XAIR executes on the LungFit PH launch and advances its pipeline, and are reiterating our Buy rating," the analyst said.

Oppenheimer analysts in a research note reiterated shares at Outperform.

Given hospital demonstration and contracting time, the Oppenheimer analysts said they view fiscal fourth-quarter 2023, the March 2023 quarter, as the first benchmark quarter of revenue.

"We believe [inhaled nitric oxide] has compelling benefits over existing cylinder technology (safety, convenience, size) and that XAIR's technology has multiple important applications," the note said.

"Due to the many advantages of the LungFit PH system, we have no plans to compete on price," Beyond Air Chief Commercial Officer Duncan Fatkin said in a conference call. Since removing cylinders leads potential workflow and logistical benefits, "there is a strong healthcare economic argument that even a higher price will still lead to reduction in the overall costs of delivering nitric oxide for hospitals," Mr. Fatkin said.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

June 29, 2022 13:10 ET (17:10 GMT)

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