[8-K] Arvinas, Inc Reports Material Event

Rhea-AI Filing Summary

Arvinas announced that the U.S. Food and Drug Administration has accepted the company’s new drug application for vepdegestrant, seeking treatment of patients with estrogen receptor positive (ER+)/HER2-negative disease whose tumors carry ESR1 mutations and who previously received endocrine-based therapy. The filing includes a company press release as Exhibit 99.1.

The FDA has assigned a Prescription Drug User Fee Act action date of June 5, 2026, establishing the target date for the agency’s decision on the application.

Insights

Biotech Financial Analyst

TL;DR: FDA acceptance and a set PDUFA date are material regulatory milestones that advance the program toward a potential market decision.

The FDA’s acceptance of the NDA for vepdegestrant signals that the application is sufficiently complete to begin formal review and that the agency has set a target action date of June 5, 2026. For investors, this moves the program from pre-submission and filing uncertainty to a defined regulatory timeline. The filing specifies the target patient population as ER+/HER2- ESR1-mutated advanced or metastatic breast cancer after prior endocrine therapy, which defines the commercial and clinical context for any approval. While acceptance is not approval, the assignment of a PDUFA date creates a clear near-term catalyst for value realization or reassessment.

Regulatory Affairs Specialist

TL;DR: NDA acceptance with a PDUFA date confirms the application will undergo standard FDA review toward a regulatory decision by the assigned date.

Acceptance of the NDA indicates the FDA found the submission sufficiently complete for review and has formally scheduled an action date of June 5, 2026. The company disclosed the acceptance and the press release is included as Exhibit 99.1. From a regulatory perspective, the set action date provides a milestone-driven timeline for review activities, interactions, and potential advisory committee scheduling, although the filing itself does not indicate the outcome of the review.

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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): August 8, 2025

__________________

Arvinas, Inc.

(Exact name of registrant as specified in its charter)

__________________

Delaware			001-38672			47-2566120
(State or other jurisdiction of incorporation)			(Commission File Number)			(IRS Employer Identification No.)

5 Science Park 395 Winchester Ave. New Haven, Connecticut			06511
(Address of principal executive offices)			(Zip Code)

Registrant’s telephone number, including area code: (203) 535-1456

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 (see General Instruction A.2. below):

o			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o			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

Trading Symbol(s)

Name of each exchange on which registered

Common stock, par value $0.001 per share

ARVN

The Nasdaq Stock Market LLC

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 o

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. o

Item 7.01 Regulation FD Disclosure.

On August 8, 2025, the Company issued a press release announcing that the U.S. Food and Drug Administration ("FDA") has accepted a new drug application ("NDA") for vepdegestrant for the treatment of patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2-negative ("HER2-") ESR1-mutated advanced or metastatic breast cancer who have previously received endocrine-based therapy.

The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.

On August 8, 2025, Arvinas, Inc. issued a press release announcing that the FDA has accepted the NDA for vepdegestrant for the treatment of patients with ER+/HER2- ESR1-mutated advanced or metastatic breast cancer who have previously received endocrine-based therapy. The FDA has assigned a Prescription Drug User Fee Act action date of June 5, 2026.

Item 9.01 Financial Statements and Exhibits.

Exhibit Number						Description of Exhibit
99.1						Press Release, dated August 8, 2025.
104						Cover Page Interactive Data File (formatted as 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.

			ARVINAS, INC.
Date: August 8, 2025			By:			/s/ Jared Freedberg
						Jared Freedberg General Counsel

FAQ

What did Arvinas (ARVN) announce in this 8-K?

Arvinas announced FDA acceptance of the NDA for vepdegestrant and disclosed a PDUFA action date of June 5, 2026.

What is the treatment indication for vepdegestrant in the filing?

Vepdegestrant is filed for ER+/HER2- ESR1-mutated advanced or metastatic breast cancer in patients who previously received endocrine-based therapy.

When will the FDA take action on the NDA for vepdegestrant?

The FDA assigned a Prescription Drug User Fee Act action date of June 5, 2026.

Does the filing include the company press release?

Yes; the press release is included as Exhibit 99.1, and the cover page interactive data file is listed as Exhibit 104.

What exchange and ticker are associated with Arvinas?

ARVN is listed on The Nasdaq Stock Market LLC.