FDA Events for Verve Therapeutics (VERV)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Verve Therapeutics (VERV).
Over the past two years, Verve Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
VERVE-102. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
VERVE-102 - FDA Regulatory Timeline and Events
VERVE-102 is a drug developed by Verve Therapeutics for the following indication: For cardiovascular disease.
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:
- VERVE-102
- Announced Date:
- April 14, 2025
- Estimated Event Date Range:
- July 1, 2025 - December 31, 2025
- Target Action Date:
- H2 2025
- Indication:
- For cardiovascular disease
Announcement
Verve Therapeutics announced that In the second half of 2025, Verve expects to report final Heart-2 dose escalation data, dose the first patient in a Phase 2 clinical trial for VERVE-102, and receive a decision from Eli Lilly and Company for the PCSK9 opt-in
AI Summary
Verve Therapeutics announced key plans for the second half of 2025 related to its VERVE-102 program. The company expects to report the final Heart-2 dose escalation data, which will provide important insights into the dosing and safety of its innovative treatment. At the same time, Verve plans to dose the first patient in a Phase 2 clinical trial for VERVE-102, marking a major step forward in its effort to offer a one-dose treatment for lowering LDL-C levels by permanently turning off the PCSK9 gene in the liver.
Additionally, Verve is awaiting a decision from Eli Lilly and Company regarding the PCSK9 opt-in, a collaboration that could share development expenses and expedite the commercialization process. These upcoming milestones highlight the company’s dedication to transforming cardiovascular disease treatment by moving from chronic therapies to a potentially lifelong, single-dose solution.
Read Announcement- Drug:
- VERVE-102
- Announced Date:
- April 14, 2025
- Indication:
- For cardiovascular disease
Announcement
Verve Therapeutics announced positive initial data from the Heart-2 Phase 1b clinical trial of VERVE-102. The Heart-2 Phase 1b clinical trial is evaluating patients with heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease (CAD), two populations that require deep and durable reductions of low-density lipoprotein cholesterol (LDL-C) levels in the blood.
AI Summary
Verve Therapeutics announced promising initial results from the Heart-2 Phase 1b clinical trial of VERVE-102. The trial is focused on patients with heterozygous familial hypercholesterolemia (HeFH) and premature coronary artery disease (CAD), two groups that need strong, lasting reductions in low-density lipoprotein cholesterol (LDL-C). In the study, a single infusion of VERVE-102 produced significant, dose-dependent drops in blood PCSK9 and LDL-C levels. Notably, participants in the 0.6 mg/kg cohort saw a mean LDL-C reduction of 53% with a maximum drop of 69%. The treatment was well-tolerated across 14 participants, with no treatment-related serious adverse events or concerning changes in laboratory values. These early results suggest that VERVE-102 could offer a breakthrough approach, potentially transforming cardiovascular disease treatment with a single dose providing lasting benefits.
Read Announcement- Drug:
- VERVE-102
- Announced Date:
- April 11, 2025
- Indication:
- For cardiovascular disease
Announcement
Verve Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VERVE-102 for the treatment of patient groups with hyperlipidemia and high lifetime cardiovascular risk to reduce low-density lipoprotein cholesterol (LDL-C).
AI Summary
Verve Therapeutics has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its investigational product VERVE-102. This designation is intended to speed up the development and review process for drugs that treat serious conditions and meet an unmet medical need. VERVE-102 targets patients with hyperlipidemia and high lifetime cardiovascular risk by reducing low-density lipoprotein cholesterol (LDL-C).
The therapy is a novel, in vivo base editing medicine designed as a single-course treatment that permanently deactivates the PCSK9 gene in the liver. By doing so, it aims to provide sustained lowering of LDL-C, which is crucial for reducing the risk of atherosclerotic cardiovascular disease. The Fast Track designation highlights the urgent need for more effective treatments for patients who struggle with managing LDL-C levels despite current therapy options.
Read Announcement- Drug:
- VERVE-102
- Announced Date:
- March 24, 2025
- Indication:
- For cardiovascular disease
Announcement
Verve Therapeutics announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for VERVE-102 for the treatment of patients living with heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease (CAD).
AI Summary
Verve Therapeutics announced that the FDA has cleared its Investigational New Drug (IND) application for VERVE-102, a new in vivo base editing medicine aimed at treating patients with heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease (CAD). VERVE-102 is designed as a single-course treatment that inactivates the PCSK9 gene in the liver to lower LDL cholesterol levels permanently. This clearance is a major step forward as the drug could offer lifelong cholesterol reduction, addressing the problem of low treatment adherence seen with current therapies. The company’s approach is intended to provide lasting benefits that could translate to reduced heart attack risks over time. As part of its ongoing clinical development, Verve plans to activate additional U.S. trial sites, further advancing its research into a treatment that may significantly improve outcomes for patients with cardiovascular disease.
Read Announcement- Drug:
- VERVE-102
- Announced Date:
- February 27, 2025
- Indication:
- For cardiovascular disease
Announcement
Verve Therapeutics, reported pipeline and corporate updates
AI Summary
Verve Therapeutics announced important pipeline updates and corporate changes in February 2025. The company’s Heart-2 Phase 1b trial of VERVE-102, which targets the PCSK9 gene to lower harmful cholesterol, has shown the treatment is well-tolerated with no serious safety issues. Initial data is expected in the second quarter of 2025, with final dose escalation results planned for the second half of the year. Additionally, Verve is progressing its ANGPTL3 program through the Pulse-1 Phase 1b trial of VERVE-201, while aiming to secure an opt-in decision from Eli Lilly later in 2025.
On the corporate side, the company announced the retirement of its long-time Chief Medical Officer, Dr. Frederick Fiedorek, with Scott Vafai, M.D. stepping in as Senior Vice President of Clinical Development. Supported by strong financial resources and a solid cash runway into mid-2027, Verve looks forward to advancing its innovative genetic medicines for cardiovascular disease.
Read Announcement- Drug:
- VERVE-102
- Announced Date:
- January 13, 2025
- Indication:
- For cardiovascular disease
Announcement
Verve Therapeutics highlighted its recent pipeline progress and anticipated 2025 milestones.
AI Summary
Verve Therapeutics announced impressive progress in its pipeline and set several key milestones for 2025. The company revealed that initial data from the Heart-2 Phase 1b clinical trial of VERVE-102, a base editing medicine targeting the PCSK9 gene to lower cholesterol, is expected in the second quarter of 2025. The trial has progressed safely through lower dose levels and is now dosing participants at 0.6 mg/kg.
In addition, Verve nominated VERVE-301 as its development candidate to target the LPA gene. This program aims to permanently lower lipoprotein(a) levels—a significant risk factor for cardiovascular disease. With the support of its proprietary GalNAc-LNP liver delivery technology and collaboration with Eli Lilly, Verve is gearing up to achieve these important milestones while ensuring its cash runway extends into mid-2027.
Read Announcement
Verve Therapeutics FDA Events - Frequently Asked Questions
As of now, Verve Therapeutics (VERV) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Verve Therapeutics (VERV) has reported FDA regulatory activity for VERVE-102.
The most recent FDA-related event for Verve Therapeutics occurred on April 14, 2025, involving VERVE-102. The update was categorized as "Dose escalation," with the company reporting: "Verve Therapeutics announced that In the second half of 2025, Verve expects to report final Heart-2 dose escalation data, dose the first patient in a Phase 2 clinical trial for VERVE-102, and receive a decision from Eli Lilly and Company for the PCSK9 opt-in"
Currently, Verve Therapeutics has one therapy (VERVE-102) targeting the following condition: For cardiovascular disease.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:VERV) was last updated on 7/12/2025 by MarketBeat.com Staff
