Verrica Pharmaceuticals ( VRCA Quick Quote VRCA - Free Report) are down in pre-market trading after it announced that the FDA has issued a Complete Response Letter (CRL) to its new drug application (NDA) for the lead product candidate, VP-102.
VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration.
The NDA is seeking approval of the candidate for the treatment of molluscum contagiosum (molluscum).
The CRL was issued as the FDA has identified deficiencies at a facility of a contract manufacturing organization (CMO) that are not specifically related to the manufacturing of VP-102 but instead raise general quality issues at the facility. Nevertheless, the agency did not identify any clinical, safety or product-specific Chemistry, Manufacturing, and Controls (CMC) deficiencies related to VP-102.
Per the company, the CMO implemented corrective actions to address the agency’s concerns and it expects a satisfactory resolution of the facility's identified deficiencies from the FDA within the next 30 business days.
During this timeframe, Verrica will engage with the FDA to demonstrate that its good manufacturing practices, controls, and processes ensure that any deficiencies at the CMO do not affect the efficacy, safety or quality of VP-102.
Molluscum, a highly contagious viral skin disease, is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching, and bacterial infection.
The company had suffered a setback earlier as well. In May, the FDA extended the Prescription Drug User Fee Act (PDUFA) goal date for the NDA for VP-102 by three months to Sep 23, 2021. The agency then needed additional time to review the information requested and submitted regarding the company’s training program and distribution model.
The agency had also issued a CRL in July 2020.
The delay in approval is disappointing for investors as this is the lead candidate for the company.
Shares of the company have gained 4.5% so far this year against the
industry’s decrease of 12.2%. Image Source: Zacks Investment Research
Verrica has successfully completed a phase II study of VP-102 for the treatment of common warts and a phase II study of VP-102 for the treatment of external genital warts.
Verrica is developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. It has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize LTX-315 for dermatologic oncology conditions.
Zacks Rank & Stocks to Consider
Verrica currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are
Regeneron Corporation ( REGN Quick Quote REGN - Free Report) , Repligen ( RGEN Quick Quote RGEN - Free Report) , and Vertex Pharmaceuticals ( VRTX Quick Quote VRTX - Free Report) . While Regeneron and Repligen sport a Zacks Rank #1 (Strong Buy), Vertex currently carries a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank stocks here
Earnings estimates for Regeneron have moved up $5.71 for 2021 in the past 60 days. The stock is up 32.7% year to date.
Earnings estimates for Repligen have moved up 50 cents for 2021 in the past 60 days. The stock is up 59.8% year to date.
Earnings estimates for Vertex have moved up $1.15 for 2021 in the past 60 days.