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 16, 2024
NUVALENT, INC.
(Exact name of registrant as specified in its charter)
| | | | |
Delaware |
| 001-40671 |
| 81-5112298 |
(State or other jurisdiction
of incorporation) |
| (Commission
File Number) |
| (I.R.S. Employer
Identification No.) |
Nuvalent, Inc.
One Broadway, 14th Floor, Cambridge, Massachusetts 02142
(Address of principal executive offices, including zip code)
(857) 357-7000
(Registrant’s telephone number, including area code)
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) |
☐ | 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 |
| Trade
Symbol(s) |
| Name of each exchange
on which registered |
Class A Common Stock, $0.0001 par value per share |
| NUVL |
| The 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 8.01. Other Events.
On May 16, 2024, Nuvalent, Inc. announced that the U.S. Food and Drug Administration granted breakthrough therapy designation to NVL-655 for the treatment of patients with locally advanced or metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer who have been previously treated with two or more ALK tyrosine kinase inhibitors.
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.
| | | | |
|
| Nuvalent, Inc. |
| | |
Date: May 16, 2024 |
| By: |
| /s/ Deborah A. Miller |
|
| |
| Deborah A. Miller, Ph.D. |
|
| |
| Chief Legal Officer and Secretary |
