UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01 Other Events.
On September 16, 2021, Biomea Fusion, Inc. (the “Company”) announced that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug application to begin a Phase 1 trial of BMF-219, a selective irreversible menin inhibitor, in adult patients with relapsed or refractory acute leukemia, including those with an MLL/KM2TA gene rearrangement or NPM1 mutation.
A copy of the press release with the foregoing announcement is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit |
Description | |
| 99.1 | Press Release dated September 16, 2021 | |
| 104 | Cover Page Interactive Data File (embedded within the inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| BIOMEA FUSION, INC. | ||||||
| Date: September 17, 2021 | By: | /s/ Thomas Butler | ||||
| Thomas Butler Chief Executive Officer | ||||||