Emergent BioSolutions (NYSE: EBS) gains FDA approval for raxibacumab production

Rhea-AI Filing Summary

Emergent BioSolutions Inc. announced that it has received approval from the U.S. Food and Drug Administration for drug product manufacturing of raxibacumab at its Winnipeg manufacturing site. This means the company is now authorized to produce this product at that facility, which supports its medical countermeasures business focused on serious public health threats. The update was shared through a press release furnished as an exhibit, and the information is presented as a Regulation FD disclosure rather than as part of the company’s audited financial statements.

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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): December 12, 2025

EMERGENT BIOSOLUTIONS INC.

(Exact name of registrant as specified in its charter)

Delaware

001-33137

14-1902018

(State or other jurisdiction

(Commission File Number)

(IRS Employer

of incorporation)

Identification No.)

 300 Professional Drive,

Gaithersburg, Maryland 20879

(Address of principal executive offices, including zip code)

(240) 631-3200

(Registrant’s telephone number, including area code)

N/A

(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 communications 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, $0.001 par value per share			EBS			New York Stock Exchange

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

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 December 12, 2025, Emergent BioSolutions Inc. (the “Company”) issued a press release regarding the Company’s receipt of U.S. Food and Drug Administration approval for drug product manufacturing of raxibacumab at the Company’s Winnipeg manufacturing site, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 7.01 and Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in any such filing.

Item 9.01    Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.						Description
99.1						Press release issued by Emergent BioSolutions Inc. on December 12, 2025.
104						Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

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.

			EMERGENT BIOSOLUTIONS INC.
Dated: December 12, 2025			By:			/s/ RICHARD S. LINDAHL
						Name: Richard S. Lindahl Title: Executive Vice President, Chief Financial              Officer and Treasurer

FAQ

What did Emergent BioSolutions (EBS) announce in this 8-K filing?

Emergent BioSolutions announced that it received U.S. Food and Drug Administration approval for drug product manufacturing of raxibacumab at its Winnipeg manufacturing site, as described in a furnished press release.

Which product is covered by the new FDA manufacturing approval for Emergent BioSolutions (EBS)?

The approval covers drug product manufacturing of raxibacumab at Emergent BioSolutions’ Winnipeg manufacturing facility.

How did Emergent BioSolutions (EBS) communicate the FDA approval to investors?

The company issued a press release on December 12, 2025, which is furnished as Exhibit 99.1 to this Form 8-K under Regulation FD Disclosure.

Does the Emergent BioSolutions (EBS) 8-K state that the FDA approval information is filed or furnished?

The information in Item 7.01 and Exhibit 99.1 is explicitly stated as being furnished, not filed, and is not incorporated into other securities law filings unless specifically referenced.

Where is the Emergent BioSolutions (EBS) manufacturing site that received FDA approval for raxibacumab?

The FDA approval relates to drug product manufacturing of raxibacumab at the company’s Winnipeg manufacturing site.

What exhibits are included with this Emergent BioSolutions (EBS) Form 8-K?

The Form 8-K includes Exhibit 99.1, the press release about the FDA approval, and Exhibit 104, the Cover Page Interactive Data File embedded within the Inline XBRL document.