Arvinas, Inc 8-K Filings

Arvinas, Inc. held its annual meeting of stockholders on June 24, 2026, where three proposals were put to a vote. Stockholders elected Class II directors Leslie V. Norwalk, Esq. and Randy Teel, Ph.D. to serve until the 2029 annual meeting of stockholders. They also approved, on a non-binding advisory basis, the compensation of the company’s named executive officers. In addition, stockholders ratified the appointment of Deloitte & Touche LLP as Arvinas’ independent registered public accounting firm for the fiscal year ending December 31, 2026.

Arvinas, Inc. announced that chief medical officer Noah Berkowitz, M.D., Ph.D. will leave the company, with his employment ending on July 3, 2026. He is expected to remain in his role until that date while the company searches for a new chief medical officer.

Under a separation agreement signed on June 22, 2026, Dr. Berkowitz receives nine months of base-salary continuation, up to nine months of company-paid health premiums, and accelerated vesting of certain restricted stock units scheduled to vest on or before May 9, 2027, with remaining awards forfeited.

Arvinas, Inc. reports that its license agreement with Rigel Pharmaceuticals and Pfizer for VEPPANU (vepdegestrant) is now effective after early Hart-Scott-Rodino antitrust clearance. Rigel has paid an aggregate $70.0 million upfront to Arvinas and Pfizer.

The partners are eligible for an additional $15.0 million upon completion of certain development and manufacturing transition work, and up to $320.0 million in future development, regulatory and commercial milestone payments, plus tiered mid-teens to mid-20s royalties on worldwide VEPPANU sales. All payments are to be split evenly between Arvinas and Pfizer, replacing unearned future amounts under their 2021 collaboration.

Arvinas, Inc. filed a current report outlining a portfolio re‑prioritization and updated plans for its ARV-806 program, along with an investor presentation for use at the Jefferies Global Healthcare Conference and other meetings.

After a strategic review, the company plans to complete the ongoing Phase 1 monotherapy dose escalation trial of ARV-806 in patients with solid tumors harboring KRAS G12D mutations and share clinical data in 2026. For any further development, such as dose expansion or combination trials, Arvinas intends to seek an out-licensing partner rather than advance ARV-806 alone. The company also reiterates that its cash, cash equivalents and marketable securities as of March 31, 2026 are expected to fund planned operating and capital spending into the second half of 2028.

Arvinas, Inc. reported first quarter 2026 results and highlighted a major strategic milestone: FDA approval of VEPPANU (vepdegestrant), the first-ever approved PROTAC protein degrader, for ESR1-mutated ER+/HER2- advanced or metastatic breast cancer after at least one line of endocrine therapy. VEPPANU was also added as a Category 2A treatment in the NCCN Breast Cancer Guidelines and is being outlicensed globally to Rigel Pharmaceuticals, with closing subject to customary approvals.

For the quarter ended March 31, 2026, revenue was $15.6 million compared with $188.8 million a year earlier, mainly reflecting lower Pfizer collaboration revenue. Arvinas posted a net loss of $57.6 million versus net income of $82.9 million in the prior-year quarter. GAAP R&D expenses fell to $60.3 million and GAAP G&A to $19.1 million, with non-GAAP R&D and G&A at $54.3 million and $13.0 million, respectively. Cash, cash equivalents, and marketable securities totaled $614.9 million as of March 31, 2026, which the company believes will fund operations into the second half of 2028, while it advances a broad PROTAC pipeline including ARV-102, ARV-806, ARV-393, ARV-027, and ARV-6723.

Arvinas, Pfizer and Rigel have signed a major licensing deal for VEPPANU. Rigel will receive exclusive global rights to develop, manufacture and commercialize VEPPANU, the first FDA‑approved PROTAC estrogen receptor degrader for certain advanced or metastatic breast cancers.

Arvinas and Pfizer will receive a $70 million upfront payment and an additional $15 million tied to specified transition activities, shared evenly between them. They may earn up to $320 million in future development, regulatory and commercial milestone payments, plus tiered royalties in the mid‑teens to mid‑20s on worldwide net sales. Rigel will lead U.S. launch and commercialization, hold global rights with sublicensing ability, and contribute up to $40 million toward ongoing development. Closing is subject to customary conditions, including Hart‑Scott‑Rodino antitrust clearance.

Arvinas, Inc. announced that the U.S. Food and Drug Administration has approved VEPPANU (vepdegestrant) to treat adults with ER-positive/HER2-negative, ESR1‑mutated advanced or metastatic breast cancer whose disease has progressed after at least one line of endocrine therapy, based on an FDA‑authorized test. VEPPANU is described as the first-and-only FDA‑approved PROTAC protein degrader, marking Arvinas’ first approved medicine and the first PROTAC therapy to reach the market. FDA approval came ahead of the June 5, 2026 PDUFA date. In the Phase 3 VERITAC‑2 trial, VEPPANU reduced the risk of disease progression or death by 43% versus fulvestrant, with median progression‑free survival of 5.0 months compared to 2.1 months. Under its collaboration with Pfizer, Arvinas will receive a $50.0 million development milestone payment tied to this approval, which will be offset by amounts owed to Yale University under a license agreement. Arvinas and Pfizer plan to select a third‑party partner to commercialize VEPPANU.

Arvinas, Inc. reported positive Phase 1 data for ARV-102, an investigational oral PROTAC degrader of LRRK2 in patients with Parkinson’s disease. Multiple daily doses of 20 mg, 40 mg, and 80 mg for 28 days were well tolerated, with only mild adverse events, no serious adverse events, no discontinuations, and no deaths, and no significant changes in lung function.

ARV-102 showed brain penetration with cerebrospinal fluid exposure increasing in a dose-dependent manner and a mean plasma half-life of 68 hours. It achieved approximately 50% or greater LRRK2 reduction in cerebrospinal fluid at all doses by day 14, maintained through day 28, and reduced endolysosomal and neuroinflammatory biomarkers such as CD68 and GPNMB.

Based on these results, Arvinas plans to continue developing ARV-102 in neurodegenerative diseases linked to LRRK2 and endolysosomal dysfunction and, pending regulatory feedback, intends to start a Phase 1b trial in progressive supranuclear palsy in the second quarter of 2026, with potential initiation of a registrational trial in late 2026.

Arvinas, Inc. reported 2025 results showing a sharply reduced net loss and a stronger balance sheet to support its PROTAC pipeline. Full-year revenue was $262.6 million, roughly flat with 2024, while the net loss narrowed to $80.8 million from $198.9 million as both R&D and G&A expenses declined.

Year-end cash, cash equivalents and marketable securities totaled $685.4 million, and the company expects this to fund operations into the second half of 2028. Arvinas highlighted multiple clinical programs, including ARV-102, ARV-806, ARV-393, ARV-027 and ARV-6723, as well as vepdegestrant, which has an FDA PDUFA action date of June 5, 2026.

The company also appointed Randy Teel, Ph.D., as President and CEO, continued progressing four ongoing clinical trials, initiated a Phase 1 study for ARV-027, and prepared to move its first immuno-oncology candidate ARV-6723 into the clinic, underscoring an active late- and mid-stage pipeline.

Arvinas, Inc. announced a leadership transition, with longtime executive Randy Teel, Ph.D. becoming president, chief executive officer, principal executive officer, and a board member effective February 12, 2026. Former CEO John Houston, Ph.D. resigned from his officer roles but remains a director and will serve as a consultant.

Teel, who joined Arvinas in 2018 and most recently served as chief business officer, will receive a $680,000 annual base salary and a performance-based bonus target equal to 60% of salary. He is also being granted a stock option for 218,691 shares and a restricted stock unit award covering 147,179 shares, both vesting over four years.

The amended employment agreement provides 12 months of salary and health premium support if Teel is terminated without cause or resigns for good reason outside a change in control, and 18 months of salary, health benefit support, a lump sum equal to 150% of target bonus, and full vesting of unvested equity if this occurs within 12 months after a change in control. Houston’s consulting agreement runs through March 1, 2027 and includes a lump-sum COBRA-related payment of $27,914.40, a $457,000 lump sum tied to the 2025 bonus, potential hourly consulting fees, and continued equity vesting.

Arvinas, Inc. reported that it announced its financial results for the quarter ended September 30, 2025 and provided a corporate update. The company released these details in a press release dated November 5, 2025, which is furnished as Exhibit 99.1 to this current report. The information in this earnings-related section is furnished rather than filed, meaning it is not subject to certain securities law liabilities unless specifically incorporated into other documents.

Arvinas (ARVN) reported new preclinical results for ARV-806, a PROTAC degrader targeting the KRAS G12D mutation, presented at the 2025 AACR‑NCI‑EORTC “Triple Meeting.” The program aims at a common KRAS mutation found in pancreatic, colorectal, and non‑small cell lung cancers.

In cell studies, ARV‑806 degraded KRAS G12D with picomolar potency and spared wild‑type and other RAS isoforms. Compared with clinical‑stage KRAS G12D ON and OFF inhibitors and another clinical‑stage G12D degrader, it showed >25‑fold greater anti‑proliferative potency, >40‑fold higher degradation potency (vs the comparable degrader), and required >10‑fold lower concentrations to induce pro‑apoptotic BIM. In a colorectal tumor xenograft model, a single IV dose achieved >90% KRAS G12D degradation for seven days, with parallel c‑MYC suppression and BIM induction for ≥5 days. Tumor models showed ≥30% volume reductions across pancreatic and colorectal CDX and a lung PDX model. The company is evaluating ARV‑806 in a Phase 1 trial in KRAS G12D‑mutated advanced solid tumors.

Arvinas (ARVN) reported new patient-reported outcomes from the Phase 3 VERITAC-2 trial of vepdegestrant, presented at ESMO 2025. The company said vepdegestrant showed a reduced risk of deterioration versus fulvestrant in patients with ESR1‑mutated, ER+/HER2‑ advanced or metastatic breast cancer previously treated with endocrine therapy, with statistically significant advantages in several PRO domains including overall health status, pain severity, and role, cognitive, emotional, and social functioning.

Vepdegestrant is an investigational PROTAC estrogen receptor degrader being developed with Pfizer as a potential monotherapy for ESR1‑mutated ER+/HER2‑ disease. Arvinas also highlighted Phase 2 TACTIVE‑N results in a neoadjuvant setting for ER+/HER2‑ localized breast cancer in postmenopausal women, where vepdegestrant demonstrated biological and clinical activity. The company furnished a press release as Exhibit 99.1 and noted the information is provided under Regulation FD and Other Events.

Arvinas, Inc. presented late-breaking Phase 1 clinical data for ARV-102, a PROTAC LRRK2 degrader, showing brain penetration and strong target reduction in early trials. In healthy volunteers, single doses up to 200 mg and multiple daily doses up to 80 mg were generally well tolerated with no discontinuations for adverse events. Repeated daily doses ≥20 mg produced > 90% reductions in LRRK2 protein in blood cells and > 50% reductions in cerebrospinal fluid (CSF); pathway biomarkers (phospho-Rab10T73 and urine BMP) were reduced.

In a small Parkinson’s cohort (15 treated, 4 placebo), single doses of 50 mg and 200 mg were well tolerated with only mild treatment-related AEs. Median PBMC LRRK2 reductions were 86% at 50 mg and 97% at 200 mg. CSF proteomics after 14 days of 80 mg daily dosing in volunteers showed decreased lysosomal and neuroinflammatory markers. The company plans to present multiple-dose patient data in 2026 and intends to advance ARV-102 development.

Arvinas, Inc. is restructuring its business and capital allocation. Management approved a workforce reduction of approximately 15%, mainly in roles tied to vepdegestrant commercialization, and expects to incur about $4.5 million in severance and related one-time termination costs, recognized primarily in the third and fourth quarters of 2025. The reduction is expected to be largely complete in the first quarter of 2026.

Arvinas and Pfizer have jointly agreed to out-license commercialization rights to vepdegestrant to a third party and plan to limit further spending on the program while seeking a partner. The company aims to optimize costs, including an additional 15% workforce reduction and tighter pipeline spending, and believes its cash, cash equivalents and marketable securities as of June 30, 2025, plus these actions, can fund operations into the second half of 2028.

The Board also authorized a share repurchase program for up to $100 million of Arvinas common stock, to be funded from working capital and executed through various methods with no set time limit.

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.