Emergent Biosolutions Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
$EBS
Biotechnology: Pharmaceutical Preparations
Health Care
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): August 29, 2024
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Item 7.01. Regulation FD Disclosure.
On August 29, 2024, Emergent BioSolutions Inc. (“Emergent”) issued a press release containing the announcement described below. A copy of this press release is attached as Exhibit 99.1 to this Current Report and incorporated herein by reference.
The information contained in this Item 7.01 shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing, under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 8.01. Other Events.
On August 29, 2024, Emergent announced U.S. Food and Drug Administration approval of Emergent’s supplemental Biologics License Application for the expansion of the indication for ACAM2000® (Smallpox and Mpox (Vaccinia) Vaccine, Live), to include immunization for the prevention of mpox disease in individuals determined to be at high risk for mpox infection. This approval follows Emergent’s announcement that it filed an Expression of Interest with the World Health Organization (“WHO”) for the WHO’s assessment of ACAM2000® vaccine to be added as an Emergency Use Listing in connection with the mpox outbreak.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 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.
| EMERGENT BIOSOLUTIONS INC. | ||||||||
| Dated: August 29, 2024 | By: | /s/ RICHARD S. LINDAHL | ||||||
| Name: Richard S. Lindahl Title: Executive Vice President, Chief Financial Officer and Treasurer | ||||||||