Current Report Filing (8-k)
May 23 2022 - 6:41AM
Edgar (US Regulatory)
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2022-05-20
2022-05-20
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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)
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Massachusetts |
0-17999 |
04-2726691 |
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(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
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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:
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Title of Each Class |
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Trading
Symbol |
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Name of Each Exchange on Which
Registered |
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Common Stock, $.01 par value |
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IMGN |
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Nasdaq Global Select Market |
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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
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.
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ImmunoGen, Inc. |
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Date: May 23, 2022 |
/s/ Renee
Lentini |
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Renee Lentini |
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Vice President and Chief Accounting Officer |
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