08:32 AM EDT, 09/08/2025 (MT Newswires) -- Beyond Air ( XAIR ) said Monday that the US Food and Drug Administration has granted orphan drug designation for its lead investigational therapy BA-101 to treat glioblastoma, which is an aggressive type of brain cancer.

Shares of the company surged over 30% during the premarket session Monday.

The FDA grants the designation to safe and effective drugs and biologics intended to treat rare diseases or disorders that affect fewer than 200,000 people in the US. The designation also provides incentives, such as tax credits toward clinical trial costs and prescription drug user fee waivers.

Drugs and treatments that receive the designation are given seven years of market exclusivity, which is independent from intellectual property protection, according to the FDA.

Price: 2.88, Change: +0.67, Percent Change: +30.32