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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): May 20, 2022

 

ImmunoGen, Inc.

(Exact name of registrant as specified in its charter)

 

 

         
  Massachusetts  0-17999 04-2726691  
  (State or other jurisdiction of
incorporation)
(Commission File Number) (IRS Employer
Identification No.)
 

830 Winter Street, Waltham, MA 02451

(Address of principal executive offices)   (Zip Code)

 

Registrant's telephone number, including area code: (781) 895-0600

 

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
  Name of Each Exchange on Which
Registered
 
  Common Stock, $.01 par value   IMGN   Nasdaq Global Select Market  

 

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 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
   

 

 

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