We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Verrica (VRCA) Gets CRL From the FDA for Skin Disease Drug
Read MoreHide Full Article
Shares of Verrica Pharmaceuticals (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 - Free Report) , Repligen (RGEN - Free Report) , and Vertex Pharmaceuticals (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.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Verrica (VRCA) Gets CRL From the FDA for Skin Disease Drug
Shares of Verrica Pharmaceuticals (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 - Free Report) , Repligen (RGEN - Free Report) , and Vertex Pharmaceuticals (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.