This section highlights FDA-related milestones and regulatory updates for drugs developed by Arvinas (ARVN).
Over the past two years, Arvinas has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ARV-102, ARV-393, ARV-766, and Vepdegestrant. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ARV-102 FDA Regulatory Timeline and Events
ARV-102 is a drug developed by Arvinas for the following indication: PROTAC® degrader designed to target the LRRK2 protein.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ARV-102
- Announced Date:
- April 4, 2025
- Indication:
- PROTAC® degrader designed to target the LRRK2 protein
Announcement
Arvinas, Inc. today presented data from the first-in-human clinical trial of ARV-102, the Company's investigational PROteolysis TArgeting Chimera (PROTAC) leucine-rich repeat kinase 2 (LRRK2) degrader.
AI Summary
Arvinas, Inc. presented promising first-in-human data for ARV-102 at the 2025 International Conference on Alzheimer’s and Parkinson’s Diseases. ARV-102 is an investigational PROTAC designed to target and degrade LRRK2, a protein linked to neurodegenerative diseases like Parkinson’s and progressive supranuclear palsy. In this Phase 1 trial with healthy volunteers, ARV-102 was found to be well tolerated, orally bioavailable, and capable of crossing the blood-brain barrier. The data showed that a single oral dose of 60 mg or repeated daily doses of 20 mg led to significant LRRK2 protein degradation—over 50% reduction in the brain’s cerebrospinal fluid and more than 90% in peripheral blood cells. These findings support continued evaluation of ARV-102 in neurodegenerative diseases, and a Phase 1 trial in Parkinson’s disease has already been initiated and is currently enrolling patients.
Read Announcement- Drug:
- ARV-102
- Announced Date:
- March 27, 2025
- Indication:
- PROTAC® degrader designed to target the LRRK2 protein
Announcement
Arvinas, Inc. a clinical-stage biotechnology company working to develop a new class of drugs based on targeted protein degradation, today announced that data from the first-in-human study evaluating single-ascending and multiple-ascending doses in healthy volunteers of ARV-102 will be presented at the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD™), April 1-5, 2025 in Vienna, Austria.
AI Summary
Arvinas, Inc., a clinical-stage biotechnology company focused on targeted protein degradation, announced that data from its first-in-human study of ARV-102 will be presented at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™) in Vienna, Austria, from April 1–5, 2025. The study evaluated both single-ascending and multiple-ascending doses in healthy volunteers. ARV-102 is an investigational PROTAC degrader that targets LRRK2, a protein associated with Parkinson’s disease and other neurodegenerative conditions. The data presentation, scheduled for April 4, 2025, will cover the drug’s safety, pharmacokinetics, and pharmacodynamics, offering new insights into its potential as a therapeutic option. This presentation marks a significant step in Arvinas’ mission to use the body’s natural protein disposal system for developing innovative treatments aimed at combating debilitating neurological disorders.
Read Announcement- Drug:
- ARV-102
- Announced Date:
- January 10, 2025
- Indication:
- PROTAC® degrader designed to target the LRRK2 protein
Announcement
Arvinas, Inc. announced that Data disclosures anticipated from multiple clinical and pre-clinical programs, including ARV-102 and planned IND submission for a PROTAC KRAS G12D degrader in 2025 –
AI Summary
Arvinas, Inc. announced several key milestones planned for 2025 that focus on advancing its PROTAC drug pipeline. Among these highlights, the company anticipates data disclosures from multiple clinical and pre-clinical programs. Notably, early data is expected from its ongoing Phase 1 trial evaluating ARV-102, an oral PROTAC LRRK2 degrader currently being studied for Parkinson’s disease. The results may provide important insights into the tolerability and potential effectiveness of the compound.
In addition, Arvinas is preparing to file an Investigational New Drug (IND) application for its novel PROTAC KRAS G12D degrader later this year. This planned IND submission represents a critical step forward in expanding the company’s development efforts in targeting previously difficult-to-treat proteins. Together, these advancements underline Arvinas’ commitment to delivering innovative therapies and addressing unmet medical needs in both neurodegenerative and oncologic conditions.
Read Announcement
ARV-393 FDA Regulatory Timeline and Events
ARV-393 is a drug developed by Arvinas for the following indication: A PROTAC® degrader designed to target the BCL6 protein.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ARV-393
- Announced Date:
- June 13, 2025
- Indication:
- A PROTAC® degrader designed to target the BCL6 protein
Announcement
Arvinas, Inc. today presented data from preclinical studies of ARV-393, the company's investigational PROteolysis TArgeting Chimera (PROTAC) B-cell lymphoma 6 protein (BCL6) degrader.
AI Summary
Arvinas, Inc. presented promising preclinical data on ARV-393, its investigational PROTAC designed to degrade the B-cell lymphoma 6 protein (BCL6), which is a key driver in certain lymphomas. In studies using patient-derived xenograft models, ARV-393 showed strong single-agent activity against nodal T-follicular helper cell lymphoma, angioimmunoblastic-type (AITL) and transformed follicular lymphoma. The data indicated that treatment with ARV-393 alone led to significant tumor burden reduction, with robust tumor growth inhibition observed in these models.
Furthermore, when ARV-393 was combined with various small molecule inhibitors, researchers recorded enhanced antitumor effects, including tumor regression, particularly in aggressive diffuse large B-cell lymphoma models. These findings suggest that ARV-393 has the potential to be used as a standalone therapy or in combination treatments, offering a promising new approach for patients with non-Hodgkin lymphoma.
Read Announcement- Drug:
- ARV-393
- Announced Date:
- June 5, 2025
- Indication:
- A PROTAC® degrader designed to target the BCL6 protein
Announcement
Arvinas, Inc. announced that new preclinical data for ARV-393 will be presented at the European Hematology Association (EHA) meeting, June 12-15, 2025 in Milan, Italy. ARV-393 is Arvinas' investigational orally bioavailable PROteolysis TArgeting Chimera (PROTAC) degrader targeting the B-cell lymphoma 6 protein (BCL6), a transcriptional repressor and major driver of B-cell lymphomas.
AI Summary
Arvinas, Inc. recently announced that it will showcase new preclinical data for its investigational drug ARV-393 at the European Hematology Association (EHA) meeting in Milan, Italy from June 12 to 15, 2025. ARV-393 is an orally bioavailable PROTAC degrader that targets the B-cell lymphoma 6 protein (BCL6), a key transcriptional repressor and major driver of B-cell lymphomas. By degrading BCL6, the drug aims to overcome challenges associated with traditional treatments for these lymphomas. The preclinical studies will explore ARV-393’s efficacy as a single agent in models of different lymphomas, including diffuse large B-cell lymphoma, nodal T-follicular helper cell lymphoma, and transformed follicular lymphoma. The data to be presented at EHA could provide valuable insights into ARV-393’s potential as a novel treatment option for patients with challenging B-cell lymphomas.
Read Announcement- Drug:
- ARV-393
- Announced Date:
- April 28, 2025
- Indication:
- A PROTAC® degrader designed to target the BCL6 protein
Announcement
Arvinas, Inc. today presented data from preclinical combination studies of ARV-393, the company's investigational PROteolysis TArgeting Chimera (PROTAC) B-cell lymphoma 6 protein (BCL6) degrader.
AI Summary
Arvinas, Inc. recently presented promising preclinical data on ARV‑393 at the 2025 AACR meeting. ARV‑393 is an investigational PROTAC designed to target and degrade B‑cell lymphoma 6 protein (BCL6), which is a key driver in B‑cell lymphomas.
The studies showed that when ARV‑393 is combined with standard-of-care chemotherapy, biologics, or select small molecule inhibitors, it produced strong synergistic antitumor effects. In aggressive models of high grade B‑cell lymphoma and diffuse large B‑cell lymphoma, these combinations led to superior tumor growth inhibition and, in some cases, complete tumor regressions compared to treatments given alone. These encouraging results support further evaluation of ARV‑393 combination strategies as potential new treatment options for patients with non‑Hodgkin lymphoma.
Read Announcement- Drug:
- ARV-393
- Announced Date:
- April 21, 2025
- Indication:
- A PROTAC® degrader designed to target the BCL6 protein
Announcement
Arvinas, Inc. announced that new preclinical combination data for ARV-393 will be presented at the American Association for Cancer Research® (AACR) Annual meeting, April 25-30, 2025 in Chicago, Illinois.
AI Summary
Arvinas, Inc., a clinical-stage biotechnology company, announced that new preclinical combination data for its investigational drug ARV-393 will be presented at the American Association for Cancer Research (AACR) Annual Meeting. This event is scheduled for April 25-30, 2025, in Chicago, Illinois.
The data focuses on ARV-393—a PROTAC degrader that targets the B-cell lymphoma 6 (BCL6) protein—and its potential to work in combination with various lymphoma treatments. The presentation, which is set for April 28, 2025, from 9:00 a.m. to 12:00 p.m. CT, will highlight the promising preclinical results where combining ARV-393 with standard-of-care therapies induced tumor regressions in diffuse large B-cell lymphoma models.
This development underscores ARV-393’s potential role in advancing treatments for B-cell lymphomas by addressing challenges associated with targeting BCL6.
Read Announcement- Drug:
- ARV-393
- Announced Date:
- January 10, 2025
- Indication:
- A PROTAC® degrader designed to target the BCL6 protein
Announcement
Arvinas, Inc. announced that Data disclosures anticipated from multiple clinical and pre-clinical programs, including RV-393 and planned IND submission for a PROTAC KRAS G12D degrader in 2025 –
AI Summary
Arvinas, Inc. announced plans to share important data from several clinical and pre-clinical programs in 2025. The company expects to disclose information from its ongoing trials with ARV-102, a PROTAC LRRK2 degrader evaluated for Parkinson’s disease, and ARV-393, a PROTAC BCL6 degrader being studied in patients with B-cell lymphomas. These updates aim to provide early insights into the safety and potential benefits of these targeted protein degradation therapies.
In addition, Arvinas plans to file an Investigational New Drug (IND) application for a novel PROTAC KRAS G12D degrader later in 2025. This submission underscores the company’s commitment to expanding its portfolio of protein degradation treatments, which could offer new options for patients with a range of serious diseases, including certain cancers and neurodegenerative disorders.
Read Announcement
ARV-766 FDA Regulatory Events
ARV-766 is a drug developed by Arvinas for the following indication: for the treatment of patients with ER positive human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ARV-766
- Announced Date:
- May 23, 2024
- Indication:
- for the treatment of patients with ER positive human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Announcement
Arvinas, Inc. announced that two abstracts, including one for ARV-766 in prostate cancer and one for TACTIVE-K, a Phase 1b/2 clinical trial with vepdegestrant, a novel investigational oral PROteolysis Targeting Chimera (PROTAC®) ER degrader, in combination with Pfizer's atirmociclib (PF-07220060), an investigational CDK4 inhibitor, were accepted for presentation at the 2024 American Society of Clinical Oncology Annual Congress held May 31 to June 4, 2024, in Chicago, IL.
AI Summary
Arvinas, Inc. announced that two abstracts have been accepted for presentation at the 2024 American Society of Clinical Oncology Annual Congress in Chicago, IL, from May 31 to June 4, 2024. One abstract covers initial results from a phase 1/2 study of ARV-766, an investigational, orally bioavailable PROTAC androgen receptor degrader, aiming to treat metastatic castration-resistant prostate cancer. The other abstract focuses on the ongoing TACTIVE-K trial—a Phase 1b/2 study evaluating vepdegestrant, a novel investigational oral PROTAC estrogen receptor degrader. This trial is being conducted in combination with Pfizer’s atirmociclib, an investigational CDK4 inhibitor, targeting advanced ER+/HER2- breast cancer. These presentations will share important insights into new targeted therapies designed to overcome treatment resistance in cancer, illustrating the potential of PROTAC technology in improving treatment outcomes.
Read Announcement
Vepdegestrant FDA Regulatory Timeline and Events
Vepdegestrant is a drug developed by Arvinas for the following indication: For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Vepdegestrant
- Announced Date:
- June 6, 2025
- Indication:
- For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Announcement
Arvinas, Inc. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with its partner Pfizer Inc.
AI Summary
Arvinas, Inc. and its partner Pfizer Inc. have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vepdegestrant, a promising new treatment for patients with advanced or metastatic ER-positive, HER2-negative breast cancer harboring ESR1 mutations. This submission is supported by positive data from the Phase 3 VERITAC-2 clinical trial. In this global study, vepdegestrant was compared to fulvestrant and showed encouraging results, suggesting it may offer a beneficial treatment option for patients who have previously undergone endocrine therapy. Vepdegestrant is an oral PROTAC protein degrader designed to target and eliminate the estrogen receptor, potentially marking the first FDA-approved therapy of its kind. This milestone could ultimately provide renewed hope and improved treatment outcomes for individuals facing a challenging form of breast cancer.
Read Announcement- Drug:
- Vepdegestrant
- Announced Date:
- March 11, 2025
- Indication:
- For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Announcement
Arvinas, Inc. and Pfizer announced positive topline results from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer whose disease progressed following prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine therapy. Inc.
AI Summary
Arvinas, Inc. and Pfizer announced positive topline results from the Phase 3 VERITAC-2 clinical trial, which compared vepdegestrant monotherapy to fulvestrant in adults with ER+/HER2– advanced or metastatic breast cancer. The trial focused on patients whose disease had progressed after treatment with CDK4/6 inhibitors and endocrine therapy. In the subgroup of patients with estrogen receptor 1 mutations, the study met its primary endpoint by showing a statistically significant and clinically meaningful improvement in progression-free survival compared to fulvestrant.
This result marks the first time a PROTAC degrader, vepdegestrant, has demonstrated clinical benefit in a Phase 3 trial. Although the trial did not reach statistical significance in the overall intent-to-treat population and overall survival data is still immature, the findings offer hope for new treatment options in this challenging patient population.
Read Announcement- Drug:
- Vepdegestrant
- Announced Date:
- February 11, 2025
- Indication:
- For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Announcement
Arvinas, Inc. provided a clinical update
AI Summary
Arvinas, Inc. provided a clinical update on its PROTAC platform for cancer therapies. The update highlighted that topline data from the Phase 3 VERITAC-2 trial for vepdegestrant, a monotherapy aimed at treating ER+/HER2- metastatic breast cancer, is expected in the first quarter of 2025. This trial marks the first ever Phase 3 study using a PROTAC technology.
In addition, Arvinas presented promising Phase 1b data from the TACTIVE-U sub-study, in which vepdegestrant was combined with abemaciclib. The results showed a clinical benefit rate of 62.5% and an overall response rate of 26.7% in patients who had previously been treated with a CDK4/6 inhibitor. The company also announced plans to begin first-line and second-line Phase 3 combination trials in 2025.
Read Announcement- Drug:
- Vepdegestrant
- Announced Date:
- January 10, 2025
- Indication:
- For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Announcement
Arvinas, Inc. announced announced updated guidance for the planned first- and second-line combination clinical trials for vepdegestrant in patients with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer, highlighted key upcoming milestones and provided a corporate update.
AI Summary
Arvinas, Inc. announced new guidance for its upcoming combination clinical trials for vepdegestrant, an oral PROTAC protein degrader targeting the estrogen receptor in patients with locally advanced or metastatic ER+/HER2- breast cancer. In 2025, a first-line Phase 3 trial will combine vepdegestrant with Pfizer’s novel investigational CDK4 inhibitor, atirmociclib. Additionally, a second-line Phase 3 trial is planned, pairing vepdegestrant with a CDK4/6 inhibitor. These studies aim to complement topline data expected from the monotherapy Phase 3 VERITAC-2 trial in the first quarter of 2025.
The updated guidance highlights key milestones for 2025 as Arvinas prepares to expand its clinical pipeline. The company is optimistic that these trials will demonstrate significant patient benefits and create meaningful value for its stockholders while solidifying its role in advancing innovative breast cancer therapies.
Read Announcement- Drug:
- Vepdegestrant
- Announced Date:
- January 10, 2025
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 2025
- Indication:
- For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Announcement
Arvinas, Inc. announced that Topline data from the monotherapy Phase 3 VERITAC-2 trial of vepdegestrant anticipated in 1Q25 –
AI Summary
Arvinas, Inc. announced that topline data from its monotherapy Phase 3 VERITAC-2 trial for vepdegestrant is expected in the first quarter of 2025. Vepdegestrant, an oral PROTAC designed to target and degrade the estrogen receptor, is being studied in patients with advanced ER-positive/HER2-negative metastatic breast cancer who have previously received endocrine-based therapy.
This development is part of a broader global collaboration with Pfizer. In addition to the monotherapy trial, Arvinas and Pfizer plan to launch two combination Phase 3 trials by the end of 2025. One trial will combine vepdegestrant with Pfizer’s novel investigational CDK4 inhibitor for first-line treatment, and another will pair it with a CDK4/6 inhibitor for second-line therapy. The anticipated Q1 2025 topline results mark a significant milestone that could benefit patients and add value for the companies involved.
Read Announcement- Drug:
- Vepdegestrant
- Announced Date:
- December 10, 2024
- Indication:
- For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Announcement
Arvinas announced preliminary data from the ongoing Phase 1b portion of the TACTIVE-U sub-study of vepdegestrant in combination with abemaciclib among patients with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer.
AI Summary
Arvinas recently shared promising preliminary findings from the Phase 1b portion of the TACTIVE-U sub-study. The study evaluated the combination of vepdegestrant with abemaciclib in patients with locally advanced or metastatic ER+/HER2- breast cancer who had previously been treated with a CDK4/6 inhibitor. Preliminary results from 16 patients showed a clinical benefit rate of 62.5% and an overall response rate of 26.7%. In addition, the study identified the recommended Phase 2 doses as 200 mg of vepdegestrant taken once daily and 150 mg of abemaciclib taken twice daily. The safety findings were in line with the known profiles of both drugs, with no significant drug-drug interactions observed. These encouraging results support the continued investigation of vepdegestrant in combination therapy for advanced breast cancer.
Read Announcement- Drug:
- Vepdegestrant
- Announced Date:
- May 16, 2024
- Indication:
- For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Announcement
Arvinas, announced updated clinical data from a Phase 1b combination cohort evaluating vepdegestrant, an investigational oral PROteolysis TArgeting Chimera (PROTAC®) estrogen receptor (ER) degrader, in combination with palbociclib (IBRANCE®).
AI Summary
Arvinas recently revealed updated clinical data from a Phase 1b study that evaluated a combination treatment using vepdegestrant and palbociclib (IBRANCE®). Vepdegestrant is an investigational oral PROTAC estrogen receptor degrader designed to target and eliminate estrogen receptors in cancer cells. The study explored the safety and potential effectiveness of this combination in patients with advanced breast cancer, a group that often faces resistance to standard hormonal therapies. Early results offer promising insights into how vepdegestrant, in tandem with palbociclib, could work to better manage hormone receptor-positive tumors. Arvinas plans to build on these encouraging findings to further investigate this novel treatment approach, aiming to provide new hope for patients who have limited options with current treatments.
Read Announcement- Drug:
- Vepdegestrant
- Announced Date:
- May 9, 2024
- Indication:
- For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Announcement
Arvinas, Inc. announced that two posters, including updated clinical trial data, for vepdegestrant will be presented at the 2024 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress held from May 15-17, 2024, in Berlin, Germany.
Read Announcement
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