UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Item 7.01 Regulation FD Disclosure.
On May 23, 2022, ImmunoGen, Inc. (the “Company”) issued a press release announcing the US Food and Drug Administration’s (the “FDA”) acceptance of the Company’s Biologics License Application (“BLA”) for mirvetuximab soravtansine, as further described below in Item 8.01 of this Current Report on Form 8-K.
The information contained in this item, including Item 99.1 attached here, 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 of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
On May 20, 2022, the FDA accepted and filed the Company’s BLA for mirvetuximab soravtansine monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments. The application has been granted Priority Review designation and the FDA has set a Prescription Drug User Fee Act action date of November 28, 2022.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
Description | |
99.1 | Press release of ImmunoGen, Inc. dated May 23, 2022 | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL (eXtensible Business Reporting Language) 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.
ImmunoGen, Inc. | |
Date: May 23, 2022 | /s/ Renee Lentini |
Renee Lentini | |
Vice President and Chief Accounting Officer | |