FDA grants orphan drug status to Beyond Air (XAIR) BA-101 for glioblastoma

Rhea-AI Filing Summary

Beyond Air, Inc. filed a report describing that its subsidiary NeuroNOS Limited has been granted U.S. Food and Drug Administration Orphan Drug Designation for BA-101, its lead investigational therapy for treating glioblastoma. This status applies to serious rare diseases and can provide development incentives. The company released a press release with more details, furnished as an exhibit, and notes that this information is provided under Regulation FD and is not deemed filed for liability purposes or automatically incorporated into other securities law filings.

Insights

Biopharma and regulatory strategy analyst

FDA orphan drug status for BA-101 is a notable milestone for Beyond Air’s glioblastoma program.

Beyond Air reports that NeuroNOS, its wholly owned subsidiary, received U.S. FDA Orphan Drug Designation for BA-101, an investigational therapy for glioblastoma. Orphan status is reserved for treatments targeting rare, serious conditions and typically reflects a defined development plan in that indication.

This designation often provides benefits such as potential market exclusivity upon approval, fee reductions, and possible development support, which can make advancing a rare-disease therapy more economically feasible. For a company focused on BA-101 as a lead program, this can strengthen the strategic rationale for continued investment in glioblastoma.

The filing confines itself to announcing the designation and attaching a press release under Regulation FD, stressing that the information is “furnished” rather than “filed.” Future company disclosures around clinical trial progress, additional regulatory interactions, or changes in development plans for BA-101 will be important to understand how this designation translates into clinical and commercial outcomes.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of report (Date of earliest event reported): September 8, 2025

Beyond Air, Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware		001-38892		47-3812456
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

900 Stewart Avenue, Suite 301

Garden City, NY 11530

(Address of Principal Executive Offices and Zip Code)

(516) 665-8200

Registrant’s Telephone Number, Including Area Code

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐	Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $.0001 per share		XAIR		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01. Regulation FD Disclosure.

On September 8, 2025, Beyond Air, Inc. (the “Company”) issued a press release announcing that NeuroNOS Limited (“NeuroNos”), a wholly owned subsidiary of Beyond Air Ireland Limited, a wholly owned subsidiary of the Company, has been granted the Orphan Drug Designation (ODD) to its lead investigational therapy, BA-101, for the treatment of Glioblastoma (GBM), by the U.S. Food and Drug Administration (FDA).

A copy of the press release is attached herewith as Exhibit 99.1.

By filing this Current Report on Form 8-K and furnishing the information contained herein, the Company makes no admission as to the materiality of any information in this report that is required to be disclosed solely by reason of Regulation FD. The Company uses, and will continue to use, its website, press releases, and various social media channels, as additional means of disclosing public information to investors, the media and others interested in the Company. It is possible that certain information that the Company posts on its website, disseminated in press releases and on social media could be deemed to be material information, and the Company encourages investors, the media and others interested in the Company to review the business and financial information that the Company posts on its website, disseminates in press releases and on the social media channels identified above, as such information could be deemed to be material information.

The information in this Item 7.01 disclosure, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that Section. In addition, the information in this Item 7.01 disclosure, including Exhibits 99.1, shall not be incorporated by reference into the filings of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press Release of Beyond Air, Inc., dated September 8, 2025.
104		Cover Page Interactive Data File (Embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	BEYOND AIR, Inc.
Date: September 8, 2025	By:	/s/ Steven A. Lisi
	Name:	Steven A. Lisi
	Title	Chief Executive Officer

FAQ

What did Beyond Air, Inc. (XAIR) disclose in this report?

Beyond Air, Inc. disclosed that its subsidiary NeuroNOS Limited received U.S. FDA Orphan Drug Designation for BA-101, its lead investigational therapy for treating glioblastoma.

Which Beyond Air subsidiary received the FDA orphan drug designation?

The designation was granted to NeuroNOS Limited, a wholly owned subsidiary of Beyond Air Ireland Limited, which is itself a wholly owned subsidiary of Beyond Air, Inc.

For which condition did BA-101 receive Orphan Drug Designation?

BA-101 received U.S. Food and Drug Administration Orphan Drug Designation for the treatment of glioblastoma, a form of brain cancer.

Does this disclosure affect Beyond Air’s SEC liability status for the information?

The company states that the Item 7.01 information, including Exhibit 99.1, is being furnished and is not deemed “filed” under Section 18 of the Exchange Act or automatically incorporated into other securities law filings.

How is Beyond Air sharing information about the BA-101 orphan drug designation?

Beyond Air issued a press release attached as Exhibit 99.1 and notes it uses its website, press releases, and social media channels as additional ways to share public information.

What exhibits are included with this Beyond Air report?

The report includes Exhibit 99.1, a press release dated September 8, 2025, and Exhibit 104, the cover page interactive data file embedded within the Inline XBRL document.