Verrica Pharmaceuticals Gains Favorable Response from EMA, Paving the Way for YCANTH® Approval in the EU
EMA Approval for YCANTH: The European Medicines Agency (EMA) has concluded that previous Phase 3 studies for YCANTH are sufficient for a Marketing Authorization Application (MAA) in the EU, with no additional studies required.
Verrica's Regulatory Submission Plans: Verrica Pharmaceuticals plans to initiate activities for the MAA filing, which could occur as early as Q4 2026, to address the significant unmet need for molluscum contagiosum treatment in Europe.
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Verrica Initiates Global Phase 3 Trial for YCANTH, Targeting Multibillion-Dollar Market
- Clinical Milestone: Verrica successfully dosed the first patient in December 2025 for its global Phase 3 trial of YCANTH, marking a significant advancement in treating common warts, with the potential to become the first approved therapy in both the U.S. and Japan, addressing the urgent needs of 22 million patients.
- Market Opportunity: With approximately 22 million patients in the U.S. alone, Verrica estimates that the common warts market could represent a multibillion-dollar opportunity, particularly as nearly 50% of these patients are children, indicating strong market potential and future growth prospects.
- Financial Backing: Verrica's recent completion of a $50 million financing and repayment of its debt to OrbiMed provides essential funding for the continued development of YCANTH, enhancing the company's competitive position in the market.
- Cost-Sharing Partnership: Verrica will share the costs of the global Phase 3 trial with Torii, which will fund the first $40 million of trial expenses, approximately 90% of the current budget, alleviating Verrica's financial burden and accelerating the clinical timeline.
Heartbeam Shares Surge Approximately 43%; Check Out 20 Stocks Making Moves in Premarket Trading
Heartbeam Inc's Stock Surge: Heartbeam Inc's shares rose 43.3% in pre-market trading after announcing its regulatory strategy following the FDA's Not Substantially Equivalent decision on its Electrocardiogram Synthesis Software, with plans for an appeal or 510(k) resubmission.
Other Notable Gainers: Several stocks saw significant gains in pre-market trading, including SMX PLC (+73.1%), Zenta Group (+26.7%), and Waton Financial (+21.1%), reflecting a positive trend in the market.
Major Losers: FBS Global Ltd experienced a sharp decline of 24.3%, while Tilray Brands fell 15% after announcing a reverse stock split, indicating volatility among certain stocks.
Market Overview: The pre-market trading session showed mixed results, with notable gains for some companies and significant losses for others, highlighting the fluctuating nature of the stock market.
Biotech and Healthcare Stocks Top After-Hours Gainers: ICU, CGTX, MESO, VRCA, AHCO
Biotech Gains in After-Hours Trading: Several small- and mid-cap biotech and healthcare companies saw significant gains in after-hours trading, driven by corporate updates and financing developments.
SeaStar Medical's Leadership Change: SeaStar Medical's stock rose nearly 10% after the appointment of Michael Messinger as Chief Financial Officer, boosting investor confidence despite no new news.
Cognition Therapeutics' Speculative Buying: Cognition Therapeutics rebounded almost 11% in after-hours trading, likely due to speculative buying interest, following a decline during regular trading hours.
Mesoblast's Revenue Projection: Mesoblast's shares increased after management projected over $30 million in gross revenue for the December quarter, indicating strong demand for its cell therapy product, Ryoncil.
Verrica Pharmaceuticals Gains Favorable Response from EMA, Paving the Way for YCANTH® Approval in the EU
EMA Approval for YCANTH: The European Medicines Agency (EMA) has concluded that previous Phase 3 studies for YCANTH are sufficient for a Marketing Authorization Application (MAA) in the EU, with no additional studies required.
Verrica's Regulatory Submission Plans: Verrica Pharmaceuticals plans to initiate activities for the MAA filing, which could occur as early as Q4 2026, to address the significant unmet need for molluscum contagiosum treatment in Europe.
Verrica Pharmaceuticals Reports Approval of YCANTH® (TO-208) in Japan for Molluscum Contagiosum Treatment by Development Partner Torii Pharmaceutical
Approval and Financial Impact: Verrica Pharmaceuticals announced that its partner, Torii Pharmaceutical, received approval for YCANTH in Japan for treating molluscum contagiosum, triggering a $10 million milestone payment to Verrica.
Product Overview: YCANTH is the first FDA-approved treatment for molluscum contagiosum, a contagious skin disease affecting millions, and is expected to establish a new standard of care while also being developed for common warts.
Verrica Pharmaceuticals Inc. (VRCA) Q2 2025 Earnings Call Transcript
Earnings Conference Call Overview: Verrica Pharmaceuticals held its Q2 2025 earnings conference call on August 12, 2025, featuring key executives including CEO Jayson Rieger and Interim CFO John Kirby, discussing the company's performance and future expectations.
Forward-Looking Statements Caution: The management emphasized that forward-looking statements made during the call are subject to risks and uncertainties, advising listeners to refer to SEC filings for important risk factors and not to overly rely on these projections.
Verrica Initiates Global Phase 3 Trial for YCANTH, Targeting Multibillion-Dollar Market
- Clinical Milestone: Verrica successfully dosed the first patient in December 2025 for its global Phase 3 trial of YCANTH, marking a significant advancement in treating common warts, with the potential to become the first approved therapy in both the U.S. and Japan, addressing the urgent needs of 22 million patients.
- Market Opportunity: With approximately 22 million patients in the U.S. alone, Verrica estimates that the common warts market could represent a multibillion-dollar opportunity, particularly as nearly 50% of these patients are children, indicating strong market potential and future growth prospects.
- Financial Backing: Verrica's recent completion of a $50 million financing and repayment of its debt to OrbiMed provides essential funding for the continued development of YCANTH, enhancing the company's competitive position in the market.
- Cost-Sharing Partnership: Verrica will share the costs of the global Phase 3 trial with Torii, which will fund the first $40 million of trial expenses, approximately 90% of the current budget, alleviating Verrica's financial burden and accelerating the clinical timeline.
Heartbeam Shares Surge Approximately 43%; Check Out 20 Stocks Making Moves in Premarket Trading
Heartbeam Inc's Stock Surge: Heartbeam Inc's shares rose 43.3% in pre-market trading after announcing its regulatory strategy following the FDA's Not Substantially Equivalent decision on its Electrocardiogram Synthesis Software, with plans for an appeal or 510(k) resubmission.
Other Notable Gainers: Several stocks saw significant gains in pre-market trading, including SMX PLC (+73.1%), Zenta Group (+26.7%), and Waton Financial (+21.1%), reflecting a positive trend in the market.
Major Losers: FBS Global Ltd experienced a sharp decline of 24.3%, while Tilray Brands fell 15% after announcing a reverse stock split, indicating volatility among certain stocks.
Market Overview: The pre-market trading session showed mixed results, with notable gains for some companies and significant losses for others, highlighting the fluctuating nature of the stock market.
Biotech and Healthcare Stocks Top After-Hours Gainers: ICU, CGTX, MESO, VRCA, AHCO
Biotech Gains in After-Hours Trading: Several small- and mid-cap biotech and healthcare companies saw significant gains in after-hours trading, driven by corporate updates and financing developments.
SeaStar Medical's Leadership Change: SeaStar Medical's stock rose nearly 10% after the appointment of Michael Messinger as Chief Financial Officer, boosting investor confidence despite no new news.
Cognition Therapeutics' Speculative Buying: Cognition Therapeutics rebounded almost 11% in after-hours trading, likely due to speculative buying interest, following a decline during regular trading hours.
Mesoblast's Revenue Projection: Mesoblast's shares increased after management projected over $30 million in gross revenue for the December quarter, indicating strong demand for its cell therapy product, Ryoncil.
Verrica Pharmaceuticals Gains Favorable Response from EMA, Paving the Way for YCANTH® Approval in the EU
EMA Approval for YCANTH: The European Medicines Agency (EMA) has concluded that previous Phase 3 studies for YCANTH are sufficient for a Marketing Authorization Application (MAA) in the EU, with no additional studies required.
Verrica's Regulatory Submission Plans: Verrica Pharmaceuticals plans to initiate activities for the MAA filing, which could occur as early as Q4 2026, to address the significant unmet need for molluscum contagiosum treatment in Europe.
Verrica Pharmaceuticals Reports Approval of YCANTH® (TO-208) in Japan for Molluscum Contagiosum Treatment by Development Partner Torii Pharmaceutical
Approval and Financial Impact: Verrica Pharmaceuticals announced that its partner, Torii Pharmaceutical, received approval for YCANTH in Japan for treating molluscum contagiosum, triggering a $10 million milestone payment to Verrica.
Product Overview: YCANTH is the first FDA-approved treatment for molluscum contagiosum, a contagious skin disease affecting millions, and is expected to establish a new standard of care while also being developed for common warts.
Verrica Pharmaceuticals Inc. (VRCA) Q2 2025 Earnings Call Transcript
Earnings Conference Call Overview: Verrica Pharmaceuticals held its Q2 2025 earnings conference call on August 12, 2025, featuring key executives including CEO Jayson Rieger and Interim CFO John Kirby, discussing the company's performance and future expectations.
Forward-Looking Statements Caution: The management emphasized that forward-looking statements made during the call are subject to risks and uncertainties, advising listeners to refer to SEC filings for important risk factors and not to overly rely on these projections.
