Verrica Pharmaceuticals Announces Completion of Enrollment in First Pivotal Phase 3 Trial (COVE-2) Evaluating YCANTH® for the Treatment of Common Warts, with Topline Data Expected Q1 2027

Verrica Pharmaceuticals (Nasdaq: VRCA) reported completion of enrollment in COVE-2, the first pivotal Phase 3 trial of YCANTH (VP-102) for treating common warts, following an interim per-protocol power analysis that recommended no additional subjects.

Rhea-AI Summary

Verrica Pharmaceuticals (Nasdaq: VRCA) reported completion of enrollment in COVE-2, the first pivotal Phase 3 trial of YCANTH (VP-102) for treating common warts, following an interim per-protocol power analysis that recommended no additional subjects. COVE-3, the second pivotal Phase 3 trial, has surpassed 50% of its current target enrollment.

According to Verrica, topline data from COVE-2 are expected in Q1 2027, with remaining Phase 3 readouts, including COVE-3, anticipated by mid-2027. The global program includes COVE-2 and COVE-3, a long-term follow‑up study (COVE-4), and a pharmacokinetics study (COVE-5). Torii Pharmaceutical, Verrica’s Japanese development partner, will fund the first $40 million of Phase 3 costs, representing about 90% of the current trial budget, within a 50/50 cost-sharing structure. Verrica highlights common warts as a major unmet need, affecting an estimated 22 million U.S. patients and lacking any FDA-approved prescription drug therapies.

Positive

• COVE-2 Phase 3 enrollment completed, with interim power analysis confirming no need for additional subjects
• COVE-3 enrollment already above 50% of target, with topline data expected by mid-2027
• Torii to fund first $40 million of global Phase 3 costs, about 90% of current budget
• Cost-sharing structure set at 50/50 between Verrica and Torii for the Phase 3 program
• Large target population: approximately 22 million U.S. patients with common warts and no FDA-approved prescription therapies
• YCANTH already FDA-approved for molluscum contagiosum, providing an existing commercial platform to leverage if label expansion succeeds

Negative

• Topline Phase 3 data timing: COVE-2 results not expected until Q1 2027, with full program readouts anticipated by mid-2027
• Regulatory success not yet established: YCANTH for common warts remains in development pending Phase 3 outcomes and marketing approvals in the U.S. and Japan

News Explained

Enrollment completion does not disclose efficacy results: the company says COVE-2 remains fully blinded, and it intends to seek U.S. approval only based on Phase 3 results.

Argus Aug 27 session 10 alerts

+3.87% close to close 14.4x rel. volume Open Argus

Details

Market move: VRCA +3.87% in the Aug 27 session. Phase 3 enrollment completion

+9.0% Peak Tracked

-3.3% Trough Tracked

$96.80M Market Cap

On Aug 27, the day this news came out, VRCA closed 3.87% above the previous close. Argus tracked a peak move of +9.0% during that session. Argus tracked a trough of -3.3% from its starting point during tracking. Our momentum scanner recorded 10 alerts for this stock that day. Relative volume reached 14.4x the daily average during tracking.

Data tracked by StockTitan Argus for the Aug 27 session.

Key Figures

COVE-3 enrollment: >50% COVE-2 topline timing: Q1 2027 Remaining topline timing: Mid-2027 +5 more

COVE-3 enrollment

>50%

Current targeted enrollment

COVE-2 topline timing

Q1 2027

Expected topline data

Remaining topline timing

Mid-2027

Expected for the broader program

Cost sharing

50/50

Verrica and Torii global Phase 3 program costs

Torii trial funding

$40 million

First portion of trial costs funded by Torii

U.S. common-warts prevalence

22 million patients

Estimated prevalence in the United States

Patient age

2+ years

Patients included in the Phase 3 program

Dosing interval

Every 21 days

VP-102/TO-208 application schedule

Previous Clinical trial Reports

5 past events · Latest: Jun 22

Same Type 5 events

1. Jun 22

   COVE-3 patient dosing

   24h Move

   +0.2%

   First U.S. patient dosed in second pivotal common-warts Phase 3 trial

2. Jan 07

   Phase 3 trial start

   24h Move

   +0.9%

   First patient dosed in global Phase 3 common-warts program after Phase 2 results

3. Nov 10

   VP-315 clinical data

   24h Move

   +11.8%

   Phase 2 VP-315 data presented, including objective response and clearance findings

4. Jul 01

   Torii trial agreement

   24h Move

   +13.4%

   Torii agreement amendment launched global Phase 3 with milestone payments

5. Jan 21

   VP-315 clinical data

   24h Move

   +5.1%

   Phase 2 VP-315 conference data reported with response and clearance results

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

per-protocol interim analysis, double-blind, vehicle-controlled, pharmacokinetics, +1 more

5 terms

per-protocol interim analysis technical

"after conducting a per-protocol interim analysis evaluating powering assumptions"

A per-protocol interim analysis is a planned mid-trial look at results that includes only participants who followed the study procedures exactly as laid out, excluding those who missed doses, deviated from treatment, or violated rules. It matters to investors because it can reveal early signs of a drug’s effectiveness or safety in an ideal-use group and influence regulatory discussions, trial timelines, and market expectations, while potentially giving a more optimistic picture than analyses that include all enrolled patients.

double-blind medical

"two double-blind, randomized, vehicle-controlled studies"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

vehicle-controlled medical

"double-blind, randomized, vehicle-controlled studies"

A vehicle-controlled study compares a drug or therapy against the same formulation without the active ingredient — the “vehicle” is the inactive carrier or delivery medium. Think of testing a recipe by serving two dishes that look and taste the same except one lacks the key ingredient; any difference shows the ingredient’s real effect. Investors watch vehicle-controlled results because they provide a cleaner measure of a treatment’s benefit and safety, shaping regulatory decisions, clinical value, and company valuation.

pharmacokinetics medical

"a pharmacokinetics study (COVE-5)"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

drug-device combination product regulatory

"YCANTH® is a proprietary drug-device combination product"

A drug-device combination product is a single marketed or investigational healthcare product that combines a pharmaceutical drug and a physical medical device so both parts contribute to the product’s intended medical effect. Think of it like a smartphone that depends on both its hardware and its software to work. It matters to investors because regulatory review, development timelines, manufacturing complexity and reimbursement rules can differ from pure drugs or pure devices, affecting cost, approval risk and market size.

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– Per-protocol interim statistical power analysis confirms no additional patients are recommended for full enrollment –

– Second pivotal Phase 3 trial (COVE-3) has already exceeded 50% of current target enrollment, with topline data currently expected in mid-2027 –

WEST CHESTER, Pa., Aug. 27, 2026 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or the “Company”) (Nasdaq: VRCA), a therapeutics company developing and commercializing medications for the treatment of dermatological diseases, including skin cancers, today announced completion of enrollment of the first pivotal clinical trial (COVE-2) of its global Phase 3 program evaluating YCANTH^® (VP-102) for the treatment of common warts.

“I am very pleased to announce substantial progress in our global Phase 3 program seeking to expand the label for YCANTH to include common warts,” said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. “We have now completed enrollment in the first pivotal trial, COVE-2, after conducting a per-protocol interim analysis evaluating powering assumptions. The interim analysis confirms that no additional subjects are recommended. We have also achieved greater than 50% of the current targeted enrollment in the second pivotal trial, COVE-3, ahead of schedule. I would like to recognize the significant effort by all involved and especially our development partner for the program, Torii Pharmaceutical,” Dr. Rieger continued.  

“We anticipate topline data from COVE-2 in the first quarter of 2027 and currently expect the remaining topline data for the program will be available by mid-2027. The potential label expansion into common warts is a cornerstone of our long-term commercial strategy and could allow us to leverage our existing sales and marketing team, call points and relationships with KOLs and payors to provide a high degree of synergy with the promotion of YCANTH for the treatment of molluscum. This clinical progress is a major step towards achieving that strategy,” said Dr. Rieger.

Noah L. Rosenberg M.D., Chief Medical Officer of Verrica, added, “Patients often try minimally effective over-the-counter therapies, with limited success and frequent recurrence of warts. If the Phase 3 program is successful, YCANTH has the potential to become the first FDA-approved prescription drug treatment for common warts, one of the largest unmet needs in dermatology. I would like to thank our clinical team, the patients, clinical sites and our external partners, including Torii, for their work to advance the program to this milestone.”

Global Phase 3 Program

Verrica has previously completed a Phase 2 study (COVE-1) which demonstrated clinically meaningful results, including a reduction in number of common warts, patients with complete clearance of common warts and durability of clearance in many patients.

The global Phase 3 program has been designed to include two double-blind, randomized, vehicle-controlled studies (COVE-2 and COVE-3) evaluating the efficacy and safety of VP-102/TO-208 when applied once every 21 days for a total of up to four applications in patients aged 2+ years with common warts. The interim analysis was done by an independent statistician, and the study remains fully blinded to the company and study team. The COVE-2 study enrolled patients in the U.S. only and the COVE-3 study is enrolling patients in the U.S. and Japan. Based on the results of the Phase 3 program, Verrica and its Japanese development partner, Torii Pharmaceutical Co. Ltd. (“Torii”), a wholly-owned subsidiary of Shionogi & Co., Ltd., intend to seek marketing approval in the U.S. and Japan, respectively. The program also includes a supportive long-term follow-up study (COVE-4) and a pharmacokinetics study (COVE-5).

Verrica and Torii will split the costs of the global Phase 3 program with Verrica on a 50/50 basis, and Torii will fund the first $40 million of trial costs, representing approximately 90% of the current trial budget. Verrica’s portion of the costs is expected to be paid out of future transfer price payments, milestones and royalties arising from sales of YCANTH in Japan.

Market Opportunity in Common Warts

With a prevalence of approximately 22 million patients in the U.S. alone and no FDA-approved prescription drug therapies, common warts represent one of the largest unmet needs in all of dermatology, which Verrica believes could represent a multibillion-dollar commercial opportunity. In the United States, approximately 50% of the patients who seek treatment for common warts are children.

About YCANTH^® (VP-102)

YCANTH^® is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical dosing and targeted administration for the treatment of molluscum. YCANTH is the first and only healthcare professional-administered product approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. Please visit YCANTHPro.com for additional information.

YCANTH is now approved for the treatment of molluscum contagiosum in Japan based upon an additional Phase 3 trial of approximately 300 patients. YCANTH is being studied in a global Phase 3 program in the US and Japan for use in the treatment of common warts.

About Verrica Pharmaceuticals Inc.

Verrica is a therapeutics company developing and commercializing medications for the treatment of dermatological diseases, including skin cancers. Verrica’s product YCANTH^® (VP-102) (cantharidin), is the first and only healthcare professional-administered treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH^® (VP-102) is also in development to treat common warts, the largest remaining unmet need in medical dermatology. Verrica has also entered a worldwide license agreement with Lytix Biopharma ASA to develop and commercialize VP-315 (ruxotemitide, formerly known as LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma.  For more information, visit www.verrica.com.

Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include statements about the clinical development and potential benefits of Verrica’s product candidates, including YCANTH (VP-102), the timing of clinical data availability, including the timing of topline results from COVE-2, the recruitment and enrollment of patients in clinical trials, including the timing of complete enrollment in COVE-3, and the potential approval of YCANTH in common warts. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include risks and uncertainties related to market conditions and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2025, Verrica’s Quarterly Reports on Form 10-Q and other filings Verrica makes with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

FOR MORE INFORMATION, PLEASE CONTACT:

Investors:

John Kirby
Interim Chief Financial Officer
jkirby@verrica.com

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Verrica Pharmaceuticals (VRCA) announce about its COVE-2 Phase 3 trial for YCANTH on August 27, 2026?

Verrica announced completion of enrollment in COVE-2, its first pivotal Phase 3 trial evaluating YCANTH for common warts. According to Verrica, a pre-specified interim power analysis recommended no additional patients, and topline COVE-2 data are expected in the first quarter of 2027.

When are Phase 3 topline results for YCANTH in common warts expected for Verrica Pharmaceuticals (VRCA)?

Topline data from COVE-2 are expected in the first quarter of 2027, with remaining Phase 3 readouts, including COVE-3, anticipated by mid-2027. According to Verrica, these results will support potential marketing applications in the U.S. and Japan.

How is Torii Pharmaceutical funding Verrica Pharmaceuticals’ (VRCA) global Phase 3 program for YCANTH?

Torii Pharmaceutical will fund the first $40 million of the global Phase 3 program, representing about 90% of the current trial budget. According to Verrica, overall Phase 3 costs are shared 50/50, with Verrica’s portion expected to be covered by future Japanese YCANTH economics.

What is the design of Verrica Pharmaceuticals’ (VRCA) Phase 3 COVE-2 and COVE-3 trials for YCANTH in common warts?

COVE-2 and COVE-3 are double-blind, randomized, vehicle-controlled studies evaluating VP-102/TO-208 applied once every 21 days, for up to four applications, in patients aged two years and older. According to Verrica, COVE-2 enrolls only U.S. patients, while COVE-3 includes U.S. and Japan.

What market opportunity does Verrica Pharmaceuticals (VRCA) see for YCANTH in treating common warts?

Verrica estimates approximately 22 million U.S. patients have common warts, with no FDA-approved prescription drug therapies available. According to Verrica, this represents one of dermatology’s largest unmet needs and could represent a multibillion-dollar commercial opportunity if YCANTH is successfully approved.

How does YCANTH currently generate revenue for Verrica Pharmaceuticals (VRCA) and how could a common warts label expansion help?

YCANTH is approved for treating molluscum contagiosum in the U.S. and Japan, providing an existing commercial base. According to Verrica, a successful common warts label expansion could leverage current sales, marketing capabilities, and physician relationships to enhance commercial efficiency and scale.

What other studies are included in Verrica Pharmaceuticals’ (VRCA) YCANTH development program beyond COVE-2 and COVE-3?

The YCANTH program includes COVE-2 and COVE-3 pivotal trials, a long-term follow-up study (COVE-4), and a pharmacokinetics study (COVE-5). According to Verrica, these additional studies support safety, durability of response, and systemic exposure data for regulatory submissions.