UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01. | Other Events. |
Cogent Biosciences, Inc. (the “Company”) announced today that it had a positive meeting with the U.S. Food and Drug Administration (the “FDA”), and that the Company reached alignment with the FDA on the Company’s novel patient reported outcome measure, Mastocytosis Symptom Severity Daily Diary (“MS2D2”), for use in Part 2 of the Company’s registration-directed SUMMIT clinical trial evaluating bezuclastinib in patients with Nonadvanced Systemic Mastocytosis.
The full text of the press release issued in connection with the announcement is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press release dated June 27, 2024. | |
| 104 | The cover page from the Company’s Current Report on Form 8-K formatted in Inline XBRL. | |
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.
| Date: June 27, 2024 | COGENT BIOSCIENCES, INC. | |||||
| By: | /s/ Evan Kearns | |||||
| Evan Kearns | ||||||
| Chief Legal Officer and Corporate Secretary | ||||||