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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 24, 2023
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Foghorn Therapeutics Inc.
(Exact name of registrant as specified in its charter)
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| Delaware | | 001-39634 | | 47-5271393 |
| (State or other jurisdiction of incorporation) | | (Commission File Number) | | (IRS Employer Identification No.) |
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| 500 Technology Square, Ste 700 | | | |
| Cambridge, | MA | | 02139 | |
| (Address of principal executive offices) | | (Zip Code) | |
(Registrant’s telephone number, including area code): (617) 586-3100
Not Applicable
(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: | | | | | |
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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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, $0.0001 par value per share | | FHTX | | The Nasdaq Global 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 8.01 Other Events.
On April 24, 2023, Foghorn Therapeutics Inc. (the "Company") issued a press release providing an update on the Company's FHD-609 program in synovial sarcoma and SMARCB1-deleted tumors. The Company announced that enrollment of the dose escalation portion of the study has been completed and a maximum tolerated dose has been identified. The Company also announced that it is pausing enrollment in the study following a grade 4 QTc prolongation event in a synovial sarcoma patient at the second highest dose. After communicating the enrollment pause to U.S. and European regulators, the Food and Drug Administration placed the study on partial clinical hold in the United States, while allowing patients currently enrolled and benefiting from therapy to continue dosing. The Company further announced that it is not at this time planning to pursue a dose expansion study independently.
A copy of the press release is attached to this Current Report as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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.
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| FOGHORN THERAPEUTICS INC. |
| By: | | /s/ Allan Reine |
| | | Allan Reine, M.D. |
| | | Chief Financial Officer |
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Date: April 24, 2023