Arvinas (ARVN) has upcoming FDA regulatory milestones for Vepdegestrant. The table below outlines estimated target dates and event types for these pending regulatory actions.
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
Vepdegestrant, ARV-102, ARV-393, ARV-471, ARV-806, and ARV-766. 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.
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:
- May 12, 2026
- Indication:
- For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Announcement
Rigel Pharmaceuticals, Inc announced that it has entered into an exclusive, global license agreement with Arvinas, Inc. (Arvinas) and Pfizer Inc. (Pfizer), subject to regulatory clearance, to develop, manufacture and commercialize VEPPANU™ (vepdegestrant), the first and only U.S. Food and Drug Administration (FDA)-approved oral PROteolysis TArgeting Chimera (PROTAC).
AI Summary
Rigel Pharmaceuticals said it has signed an exclusive global license deal with Arvinas and Pfizer to develop, make, and sell VEPPANU™ (vepdegestrant), an FDA-approved oral PROTAC, subject to regulatory clearance. Under the agreement, Pfizer and Arvinas will keep handling the current development work, while Rigel will pay up to $40 million for certain development activities over the next four years. If sales succeed, Arvinas and Pfizer could earn tiered royalties in the mid-teens to mid-twenties, plus as much as $320 million more tied to regulatory and commercial milestones.
Rigel will lead the U.S. launch and commercialization of VEPPANU and will also hold global rights outside the U.S., with the option to sublicense the drug to other partners. In that case, Arvinas and Pfizer would receive a share of any sublicensing revenue from outside the U.S. The deal is expected to close in mid-June 2026, once standard closing conditions, including antitrust clearance, are met.
Read Announcement- Drug:
- Vepdegestrant
- Announced Date:
- May 1, 2026
- Indication:
- For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Announcement
Arvinas, Inc. today with its partner Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) has granted approval for VEPPANU (vepdegestrant) for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
AI Summary
Arvinas, Inc. and partner Pfizer Inc. announced that the U.S. Food and Drug Administration has approved VEPPANU (vepdegestrant) for adults with estrogen receptor–positive (ER+), HER2‑negative, ESR1‑mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. The mutation must be detected by an FDA‑authorized test.
VEPPANU is the first‑and‑only FDA‑approved PROTAC, a new class of heterobifunctional protein degraders, and provides a novel treatment option in a setting where resistance to standard endocrine therapies is a major clinical challenge. The approval was granted ahead of the FDA‑assigned PDUFA date of June 5, 2026.
Arvinas and Pfizer said they intend to jointly identify and select a third‑party partner to maximize VEPPANU’s commercial potential and remain on track to announce that selection. Patients should discuss testing and treatment suitability with their healthcare provider.
Read Announcement- Drug:
- Vepdegestrant
- Announced Date:
- October 20, 2025
- Indication:
- For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Announcement
Arvinas, Inc. announced new patient-reported outcomes (PRO) data from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant, which are being presented in a mini oral session at the 2025 European Society for Medical Oncology (ESMO) Congress.
AI Summary
Arvinas, Inc. announced new patient-reported outcomes (PRO) data from its Phase 3 VERITAC-2 trial evaluating vepdegestrant, a novel PROTAC estrogen receptor degrader, in patients with ESR1-mutated, ER+/HER2- advanced or metastatic breast cancer. These data, presented in a mini oral session at the 2025 European Society for Medical Oncology (ESMO) Congress, showed vepdegestrant maintained overall quality of life significantly longer than fulvestrant. Patients on vepdegestrant also experienced delayed worsening of overall health, daily functioning, and symptoms such as pain.
These PRO findings complement earlier efficacy and safety results, reinforcing vepdegestrant’s potential as a second-line monotherapy for patients whose cancer progressed after endocrine-based therapy. Across multiple domains—role, cognitive, emotional, and social functioning—vepdegestrant consistently reduced the risk of deterioration compared to fulvestrant.
Overall, the data highlight vepdegestrant’s promise to improve both clinical outcomes and day-to-day well-being for patients facing ESR1-mutated advanced or metastatic breast cancer.
Read Announcement- Drug:
- Vepdegestrant
- Announced Date:
- October 13, 2025
- Indication:
- For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Announcement
Arvinas, Inc. announced that new data for vepdegestrant will be presented at the European Society for Medical Oncology (ESMO) Congress to be held October 17 through 21, 2025, in Berlin, Germany.
AI Summary
Arvinas, Inc. announced that new data for vepdegestrant will be presented at the European Society for Medical Oncology (ESMO) Congress, taking place October 17–21, 2025 in Berlin. This data highlights patient-reported outcomes (PROs) from the Phase 3 VERITAC-2 clinical trial.
Vepdegestrant is an investigational, orally available PROTAC estrogen receptor (ER) degrader. Developed in collaboration with Pfizer, it targets ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations and is also being studied in combination therapies.
The mini oral session on Monday, October 20, 2025 (11:25–11:30 CEST) will feature “Patient-reported outcomes with vepdegestrant vs fulvestrant in ESR1-mutated ER+/HER2- advanced breast cancer,” presented by Dr. Mario Campone (Presentation Number: 489MO).
On Sunday, October 19, 2025 (10:40–10:45 CEST), Dr. Peter A. Fasching will present TACTIVE-N, a Phase 2 study comparing neoadjuvant vepdegestrant to anastrozole in postmenopausal ER+/HER2- localized breast cancer (Presentation Number: 293MO).
Full abstracts are available through the ESMO online program. Ongoing studies continue to explore vepdegestrant as both monotherapy and in combination regimens for ER+/HER2- breast cancer.
Read Announcement- Drug:
- Vepdegestrant
- Announced Date:
- August 8, 2025
- Target Action Date:
- June 5, 2026
- Indication:
- For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Announcement
Arvinas, Inc. announced that The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026.
AI Summary
Arvinas and Pfizer announced the FDA has accepted the New Drug Application for vepdegestrant, an oral PROTAC estrogen receptor degrader for ER+/HER2- ESR1-mutated advanced breast cancer. The submission is based on the Phase 3 VERITAC-2 trial showing a significant improvement in median progression-free survival versus fulvestrant. Vepdegestrant is the first PROTAC to show clinical benefit in breast cancer.
The trial enrolled over 600 patients in 25 countries who had prior endocrine therapy and a CDK4/6 inhibitor. Results were presented at ASCO 2025 and published in The New England Journal of Medicine. Arvinas says if approved, vepdegestrant could be a best-in-class second-line treatment due to its efficacy and good tolerability.
The FDA set a PDUFA action date of June 5, 2026. Arvinas and Pfizer plan to work with the FDA for rapid approval to bring vepdegestrant to patients with limited options.
Read Announcement- Drug:
- Vepdegestrant
- Announced Date:
- August 8, 2025
- Indication:
- For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Announcement
Arvinas, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the 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.
AI Summary
Arvinas and Pfizer announced that the U.S. Food and Drug Administration has accepted their New Drug Application for vepdegestrant. This investigational oral drug targets estrogen receptors in adults with ER+/HER2– advanced or metastatic breast cancer who carry ESR1 mutations and have already received endocrine therapy. The FDA has set a Prescription Drug User Fee Act date of June 5, 2026.
Vepdegestrant is a PROTAC estrogen receptor degrader. Its NDA is based on the Phase 3 VERITAC-2 trial comparing it to fulvestrant. The study demonstrated a statistically significant and clinically meaningful improvement in median progression-free survival for patients with ESR1-mutant tumors. The trial enrolled 624 patients at 213 sites across 25 countries, including 270 with ESR1 mutations.
With its strong efficacy and favorable tolerability, vepdegestrant could become a best-in-class second-line therapy for this hard-to-treat breast cancer group. Arvinas and Pfizer plan to work closely with the FDA to bring this option to patients as quickly as possible.
Read Announcement- 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
- Target Action Date:
- Q1 2025
- Estimated Target Date Range:
- January 1, 2025 - March 31, 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:
- 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:
- 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
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:
- March 18, 2026
- Indication:
- PROTAC® degrader designed to target the LRRK2 protein
Announcement
Arvinas, Inc. today presented data from a Phase 1 clinical trial of ARV-102, an investigational PROteolysis TArgeting Chimera (PROTAC) degrader designed to specifically target and degrade leucine-rich repeat kinase 2 (LRRK2).
AI Summary
Arvinas reported Phase 1 results for ARV-102, an investigational, orally available PROTAC designed to cross the blood-brain barrier and selectively degrade LRRK2, a protein linked to Parkinson’s disease and some tauopathies like progressive supranuclear palsy (PSP). The multiple-dose cohort enrolled patients with Parkinson’s disease who received 20, 40, or 80 mg once daily for 28 days.
ARV-102 reduced endolysosomal and neuroinflammatory biomarkers that are implicated in PD and PSP. The treatment was well tolerated across all dose levels: all adverse events were mild, with no serious adverse events, no discontinuations, and no deaths. No meaningful changes in lung function or respiratory symptoms were observed during treatment and follow-up.
Pharmacokinetic and pharmacodynamic findings supported target engagement and encourage further development of ARV-102 in neurodegenerative diseases characterized by lysosomal dysfunction, including PSP. The data were presented at the AD/PD 2026 conference.
Read Announcement- Drug:
- ARV-102
- Announced Date:
- March 11, 2026
- Indication:
- PROTAC® degrader designed to target the LRRK2 protein
Announcement
Arvinas, Inc. announced that data from a Phase 1 clinical trial of ARV-102 in participants with Parkinson's disease (PD) will be presented at the 2026 International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD™ 2026), March 17-21, 2026, in Copenhagen, Denmark.
AI Summary
Arvinas announced that data from a Phase 1 clinical trial of ARV-102 in people with Parkinson’s disease will be presented at the AD/PD™ 2026 conference in Copenhagen, March 17–21, 2026. ARV-102 is an investigational, orally available PROTAC degrader designed to cross the blood-brain barrier and target LRRK2, a protein linked to Parkinson’s disease and progressive supranuclear palsy. The Phase 1 study evaluated multiple doses and focused on safety, pharmacokinetics (how the drug moves through the body), and pharmacodynamics (the drug’s biological effects).
The presentation, titled “Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ARV-102, a PROTAC LRRK2 Degrader, in Participants with Parkinson’s Disease,” is part of the symposium “Modulating Neuroinflammation, Α‑Synuclein, LRRK2, and Dopaminergic Repair: Early Human Data.” It will be held in Hall 180–181 on March 18, 2026, from 3:30–3:45 PM CET. The full abstract is available through the AD/PD 2026 interactive program.
Read Announcement- Drug:
- ARV-102
- Announced Date:
- October 5, 2025
- Indication:
- PROTAC® degrader designed to target the LRRK2 protein
Announcement
Arvinas, Inc. announced positive pharmacokinetic, pharmacodynamic, and biomarker data from two Phase 1 clinical trials evaluating ARV-102, an oral, brain-penetrant investigational PROTAC degrader of leucine-rich repeat kinase 2 (LRRK2).
AI Summary
Arvinas announced positive pharmacokinetic, pharmacodynamic and biomarker data from two Phase 1 trials of ARV-102, an oral, brain-penetrant PROTAC degrader of LRRK2. The drug was well tolerated in both healthy volunteers and Parkinson’s disease patients, with no serious adverse events and only mild side effects at doses up to 200 mg.
Pharmacokinetic results showed dose-dependent increases in plasma and cerebrospinal fluid (CSF), confirming brain exposure. Pharmacodynamic analysis revealed that daily doses of at least 20 mg produced over 90% reduction of LRRK2 protein in blood cells and more than 50% reduction in CSF. Biomarker measurements also showed lower levels of phospho-Rab10 and bis(monoacylglycerol)phosphate, indicating engagement of the lysosomal pathway.
In healthy volunteers treated with 80 mg once daily for 14 days, unbiased CSF proteomics demonstrated significant decreases in lysosomal and neuroinflammatory microglial markers linked to Parkinson’s disease. These findings support further development of ARV-102 in Parkinson’s and other neurodegenerative disorders.
Read Announcement- Drug:
- ARV-102
- Announced Date:
- October 1, 2025
- Indication:
- PROTAC® degrader designed to target the LRRK2 protein
Announcement
Arvinas, Inc. announced that two presentations, including one e-poster session and one oral platform presentation, featuring clinical data for ARV-102, an investigational oral PROTAC (PROteolysis TArgeting Chimera) degrader of leucine-rich repeat kinase 2 (LRRK2), will be presented at the 2025 International Congress of Parkinson's Disease and Movement Disorders® (MDS 2025) being held October 5–9, 2025, in Honolulu.
AI Summary
Arvinas, Inc. announced that it will present clinical data for ARV-102, its investigational oral PROTAC degrader of LRRK2, at the 2025 International Congress of Parkinson’s Disease and Movement Disorders (MDS 2025) in Honolulu, October 5–9, 2025.
The first presentation, an e-poster session titled “First-in-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ARV-102 in Healthy Participants,” will take place on October 7 from 12:00 to 1:00 p.m. HST (Poster 904).
The second, a late-breaker oral platform presentation called “First Clinical Trials of ARV-102, a PROTAC LRRK2 Degrader: Characterization of Pathway Engagement in Healthy Volunteers and Patients With Parkinson’s Disease,” is scheduled for October 8 from 12:00 to 1:00 p.m. HST (Late Breaker Abstract 22).
ARV-102 is designed to enter the brain and selectively degrade LRRK2, a kinase linked to familial and idiopathic Parkinson’s disease. Additional details and abstracts are available on the MDS 2025 website.
Read Announcement- 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:
- December 6, 2025
- Indication:
- A PROTAC® degrader designed to target the BCL6 protein
Announcement
Arvinas, Inc. announced preclinical data for ARV-393, a PROTAC BCL6 degrader, in combination with glofitamab, a CD20×CD3 bispecific antibody, presented in a poster at the 67th American Society of Hematology (ASH®) Annual Meeting and Exposition, held December 6–9, 2025, in Orlando, Florida.
AI Summary
Arvinas presented preclinical data at the 67th ASH meeting (Dec 6–9, 2025) showing that ARV-393, an oral PROTAC that degrades BCL6, combined with glofitamab, a CD20×CD3 bispecific antibody, produced strong anti-tumor activity. The company said these results support adding a chemotherapy-free combination cohort to its ongoing Phase 1 trial, planned for 2026.
In a humanized high-grade B‑cell lymphoma CDX model, ARV-393 (3 mg/kg) plus glofitamab (0.15 mg/kg) achieved 81% tumor growth inhibition (TGI) with concomitant dosing and 91% with sequential dosing, versus 38% and 36% for each agent alone. At a higher ARV-393 dose (6 mg/kg) the combo produced more tumor regressions (10/10 mice concomitant; 7/8 sequential) compared with single agents.
RNA sequencing and biomarker work showed ARV-393 upregulated CD20 and genes tied to interferon signaling and antigen presentation while lowering proliferation genes, suggesting BCL6 degradation boosts T‑cell engagement and drives the observed synergy. Arvinas plans to test the combo in DLBCL patients in 2026.
Read Announcement- 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.
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ARV-471 FDA Regulatory Events
ARV-471 is a drug developed by Arvinas for the following indication: 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-471
- Announced Date:
- November 24, 2025
- Indication:
- Breast cancer
Announcement
Arvinas, Inc. announced that multiple abstracts on vepdegestrant (ARV-471) have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS), taking place December 9–12, 2025 in San Antonio, Texas.
AI Summary
Arvinas announced that multiple abstracts on vepdegestrant (ARV-471) were accepted for presentation at the San Antonio Breast Cancer Symposium (SABCS), December 9–12, 2025. Accepted presentations include subgroup analyses from the VERITAC-2 Phase 3 trial (poster spotlight PD10-03, Erika P. Hamilton, Dec 12), circulating tumor DNA biomarker analyses from a Phase 1/2 study (PS2-07-24, Seth A. Wander, Dec 10), real-world prevalence of ESR1 mutations after first-line therapy (PS1-11-09, David Chandiwana, Dec 10), the I‑SPY2 Endocrine Optimization Pilot on neoadjuvant vepdegestrant (PD10-02, Jo Chien, Dec 12), and a trial-in-progress poster on a KAT6 inhibitor plus vepdegestrant (PS5-09-30, Fengting Yan, Dec 12).
Vepdegestrant is an investigational, oral PROTAC estrogen receptor degrader being developed with Pfizer for ER+/HER2− advanced or metastatic breast cancer, including tumors with ESR1 mutations. The full abstracts will be available through the SABCS online program. These presentations will share clinical, biomarker, and real-world data on vepdegestrant as monotherapy and in combination regimens.
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ARV-806 FDA Regulatory Timeline and Events
ARV-806 is a drug developed by Arvinas for the following indication: a PROTAC KRAS G12D Degrader.
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-806
- Announced Date:
- November 5, 2025
- Indication:
- a PROTAC KRAS G12D Degrader
Announcement
Arvinas, Inc. provided a corporate update.
AI Summary
In its corporate update, Arvinas highlighted strong progress across its early-stage pipeline as it enters a data-rich period. The company reported positive Phase 1 results for ARV-102, an oral LRRK2 degrader, showing dose-dependent brain penetration, robust reduction of target protein in blood and cerebrospinal fluid, and good tolerability in healthy volunteers and Parkinson’s patients.
Preclinical studies for ARV-806, a KRAS G12D degrader, demonstrated potent, selective tumor regression in pancreatic, colorectal, and lung cancer models with sustained degradation after a single dose. Arvinas also presented data on ARV-027, which showed strong clearance of disease-causing polyQ-AR protein and improved muscle strength in models of spinal bulbar muscular atrophy.
Additionally, Arvinas and Pfizer agreed to jointly select a third party to handle commercialization and further development of vepdegestrant. A conference call is scheduled today at 8:00 a.m. ET to discuss these updates and recent financial results.
Read Announcement- Drug:
- ARV-806
- Announced Date:
- October 24, 2025
- Indication:
- a PROTAC KRAS G12D Degrader
Announcement
Arvinas, Inc. announced preclinical data for ARV-806, a PROTAC KRAS G12D degrader, at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, Massachusetts.
AI Summary
At the 2025 AACR-NCI-EORTC conference in Boston, Arvinas, Inc. revealed preclinical data for ARV-806, a PROTAC degrader targeting the KRAS G12D mutation. ARV-806 showed strong potency, antiproliferative activity, and induction of cancer cell death in lab studies.
In vitro, it degraded KRAS G12D with picomolar potency in pancreatic, colorectal, and lung cancer lines, while sparing wild-type RAS proteins. Compared to other agents, it displayed over 25-fold greater antiproliferative strength and over 40-fold higher degradation potency.
In vivo, a single intravenous dose resulted in over 90% KRAS G12D degradation for seven days, along with lasting c-MYC suppression and BIM induction. Tumor models showed at least 30% volume reduction in pancreatic and colorectal xenografts and a lung cancer PDX.
These findings highlight ARV-806’s durability and support intermittent dosing. Arvinas is now testing ARV-806 in a Phase 1 trial for patients with KRAS G12D-mutated advanced solid tumors.
Read Announcement- Drug:
- ARV-806
- Announced Date:
- October 22, 2025
- Indication:
- a PROTAC KRAS G12D Degrader
Announcement
Arvinas, Inc. announced that preclinical data for ARV-806, a PROTAC KRAS G12D degrader, will be presented at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, Massachusetts.
AI Summary
Arvinas, Inc. announced that preclinical data for ARV-806, a PROTAC KRAS G12D degrader, will be presented at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston. The poster presentation (Number B107) will occur in Poster Session B on October 24, 2025, from 12:30 to 4:00 p.m. ET.
ARV-806 is an investigational PROTAC degrader designed to selectively target and degrade KRAS G12D. KRAS is one of the most frequently mutated oncogenes, and G12D is its most common form. By removing this protein, ARV-806 could address unmet needs in solid tumors such as pancreatic, colorectal, and lung cancer. It is in a Phase 1 trial for patients with advanced tumors carrying KRAS G12D mutations.
Arvinas is a clinical-stage biotechnology company pioneering targeted protein degradation therapies. The full abstract for the ARV-806 presentation is available through the AACR-NCI-EORTC program.
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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.
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