Nuvalent (NUVL) completes FDA NDA submission for zidesamtinib in ROS1+ NSCLC

Rhea-AI Filing Summary

Nuvalent, Inc. filed a current report describing a key regulatory milestone for its lead oncology program. On September 22, 2025, the company completed submission of a New Drug Application to the U.S. Food and Drug Administration for zidesamtinib as a treatment for tyrosine kinase inhibitor pre-treated patients with advanced ROS1-positive non-small cell lung cancer. This step means Nuvalent has finished providing the clinical and other data the agency needs to begin its formal review of the drug candidate for this specific patient group.

Insights

Biopharma regulatory and oncology specialist

Nuvalent reaches an important FDA milestone with its zidesamtinib NDA submission.

Nuvalent has completed a New Drug Application submission to the U.S. Food and Drug Administration for zidesamtinib in tyrosine kinase inhibitor pre-treated patients with advanced ROS1-positive non-small cell lung cancer. An NDA submission indicates the company believes its clinical and supporting data package is sufficiently mature for formal FDA review in this specific setting.

This development shifts zidesamtinib from a purely clinical-stage asset into the regulatory review phase, which is typically a critical transition point for oncology programs. The filing, however, does not describe the proposed labeling, review timelines, or any expedited designations, so the scope and pace of review are not detailed here.

Subsequent public communications or regulatory correspondence will be needed to clarify key elements such as the FDA’s acceptance of the filing, target action date, and any advisory committee plans, which will further define the path toward a potential commercial opportunity in ROS1-positive non-small cell lung cancer.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Understanding 8-K Material Events →

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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): September 22, 2025

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 September 22, 2025, Nuvalent, Inc. announced the completion of its New Drug Application submission to the U.S. Food and Drug Administration for zidesamtinib in tyrosine kinase inhibitor pre-treated patients with advanced ROS1-positive non-small cell lung cancer.

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.

			Nuvalent, Inc.
Date:	September 22, 2025	By:	/s/ Deborah A. Miller, Ph.D.
			Deborah A. Miller, Ph.D. Chief Legal Officer and Secretary

FAQ

What key event did Nuvalent (NUVL) report in this 8-K?

Nuvalent reported that on September 22, 2025, it completed submission of a New Drug Application to the U.S. Food and Drug Administration for its drug candidate zidesamtinib.

What is zidesamtinib being developed to treat according to Nuvalent’s filing?

Zidesamtinib is being developed for tyrosine kinase inhibitor pre-treated patients with advanced ROS1-positive non-small cell lung cancer.

Which regulator is reviewing Nuvalent’s zidesamtinib application?

The New Drug Application for zidesamtinib has been submitted to the U.S. Food and Drug Administration for review.

Does the Nuvalent (NUVL) 8-K announce FDA approval of zidesamtinib?

No. The 8-K states that Nuvalent completed submission of a New Drug Application to the FDA; it does not state that the drug has been approved.

What SEC form did Nuvalent use to disclose the zidesamtinib NDA submission?

Nuvalent used a Form 8-K current report to disclose the completion of its New Drug Application submission for zidesamtinib.

Who signed the Nuvalent 8-K related to the zidesamtinib NDA submission?

The 8-K was signed on behalf of Nuvalent, Inc. by Deborah A. Miller, Ph.D., the company’s Chief Legal Officer and Secretary.