Beyond Air (XAIR) Stock Gains Almost 20% on FDA Approval

  • Beyond Air (XAIR) stock jumped nearly 20% in early trading and is trending on many social media websites.
  • The company's LungFit PH device was approved by the Food and Drug Administration (FDA).
  • LungFit PH provides nitric oxide to some newborns who have respiratory failure.
XAIR stock - Beyond Air (XAIR) Stock Gains Almost 20% on FDA Approval

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Beyond Air (NASDAQ:XAIR) stock jumped nearly 20% in early trading and is trending on many social media websites. The company’s LungFit PH device, which treats some of the newborns who have respiratory failure, was approved by the Food and Drug Administration (FDA).

The company also reported a higher-than-expected loss for its fiscal fourth quarter and disclosed that it had $80.2 million of cash and cash equivalents as of March 31.

 Beyond Air’s LungFit PH Device Received FDA Approval

Beyond Air disclosed that, on June 28, the FDA had approved its LungFit PH device for newborns with hypoxic respiratory failure who were born after nine months or nearly nine months of pregnancy. Infants with hypoxic respiratory failure have abnormally low levels of oxygen in their blood, while the amount of carbon dioxide in their blood is “close to normal.”

LungFit PH creates “on-demand nitric oxide from room air,” Beyond Air explained. The only device of its kind, it can provide “unlimited” nitric oxide to patients within a minute of its activation, according to the company. Nitric oxide “relaxes the inner muscles of the blood vessels, causing them to widen and increase circulation.”

“We believe the introduction of this groundbreaking system, LungFit PH, will transform the way nitric oxide is used by hospital staff and provide numerous benefits related to safety and cost,” said Beyond Air CEO Steve Lisi in a statement.

The company added that LungFit PH is “on track” to be approved by the EU’s drug and medical device regulator.

About Beyond Air

The company is also developing LungFit Pro which, according to its marketing material, can provide supplemental oxygen, is programmable, and can treat multiple patients. The LungFit GO is still undergoing testing but is a more portable version of the PRO. It delivers nitrous oxide in patients’ home and the company is in the early stages of developing it as a “ultra-high concentration gaseous NO (UNO) therapy for solid tumors.”

XAIR Stock and Financial Results

The company’s Q4 loss per share came in at $1.68, versus analysts’ average estimate of a $1.21 loss per share. It had no revenue in Q4 or in the previous three quarters. For its entire fiscal year, which ended on March 31, Beyond Air’s net loss came in at $44.4 million.

Heading into today. XAIR stock had tumbled nearly 40% so far this year.

On the publication date, Larry Ramer did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.

Larry Ramer has conducted research and written articles on U.S. stocks for 15 years. He has been employed by The Fly and Israel’s largest business newspaper, Globes. Larry began writing columns for InvestorPlace in 2015. Among his highly successful, contrarian picks have been GE, solar stocks, and Snap. You can reach him on StockTwits at @larryramer.


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