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Verrica Pharmaceuticals (VRCA - Free Report) announced that the FDA has extended the review period for the new drug application (“NDA”) for its lead pipeline candidate, VP-102, by three months. The regulatory authority was previously expected to give a decision related to the NDA by Jun 23, which is now expected by Sep 23, 2021.
Please note that the NDA is seeking approval of its proprietary drug-device combination candidate, VP-102, as a potential treatment of molluscum contagiosum (molluscum), a highly contagious and primarily pediatric viral skin disease. There is no FDA-approved therapy or an established standard of care for this indication, suggesting significant market opportunity for the candidate following a potential approval.
Shares of Verrica fell 4.4% following the delay in the PDUFA date. In fact, the company’s shares have declined 2.1% so far this year compared with the industry’s decrease of 10.9%.
Image Source: Zacks Investment Research
We remind investors that the company had originally filed the NDA for VP-102 in September 2019. However, the FDA issued a complete response letter for the NDA in July 2020, noting deficiencies that preclude discussion of labeling and post-marketing requirements/commitments. The regulatory agency requested additional data on chemistry, manufacturing and controls as well as Human Factors validation. The company re-submitted the NDA with the requested data in December last year. The FDA accepted the re-submission in February and set a PDUFA goal date of Jun 23, 2021.
The company in its recent press release stated that the FDA has extended the review period for the VP-102 NDA as the regulatory body needs additional time to review the requested data submitted in February.
Apart from molluscum, Verrica is also developing the candidate as a potential treatment for common warts and external genital warts in mid-stage clinical studies. The company is planning a phase II study on its another pipeline candidate, VP-103, as a potential treatment for plantar warts. It plans to submit an investigational new drug application for its pre-clinical candidate, LTX-315, in the second half of 2021 to evaluate it in malignant and pre-malignant dermatological indications.
Xencor’s loss per share estimates have narrowed 34% for 2021 over the past 30 days.
Organogenesis’ earnings per share estimates have increased 200% for 2021 over the past 30 days. The stock has jumped 136.8% so far this year.
Zoetis’ earnings per share estimates have moved 1.6% north for 2021 over the past 30 days.
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In 2021, this world-changing technology is projected to generate $327.5 billion in revenue. Now Shark Tank star and billionaire investor Mark Cuban says AI will create "the world's first trillionaires." Zacks' urgent special report reveals 3 AI picks investors need to know about today.
Image: Bigstock
Verrica's (VRCA) Skin Disease Candidate Approval Gets Delayed
Verrica Pharmaceuticals (VRCA - Free Report) announced that the FDA has extended the review period for the new drug application (“NDA”) for its lead pipeline candidate, VP-102, by three months. The regulatory authority was previously expected to give a decision related to the NDA by Jun 23, which is now expected by Sep 23, 2021.
Please note that the NDA is seeking approval of its proprietary drug-device combination candidate, VP-102, as a potential treatment of molluscum contagiosum (molluscum), a highly contagious and primarily pediatric viral skin disease. There is no FDA-approved therapy or an established standard of care for this indication, suggesting significant market opportunity for the candidate following a potential approval.
Shares of Verrica fell 4.4% following the delay in the PDUFA date. In fact, the company’s shares have declined 2.1% so far this year compared with the industry’s decrease of 10.9%.
We remind investors that the company had originally filed the NDA for VP-102 in September 2019. However, the FDA issued a complete response letter for the NDA in July 2020, noting deficiencies that preclude discussion of labeling and post-marketing requirements/commitments. The regulatory agency requested additional data on chemistry, manufacturing and controls as well as Human Factors validation. The company re-submitted the NDA with the requested data in December last year. The FDA accepted the re-submission in February and set a PDUFA goal date of Jun 23, 2021.
The company in its recent press release stated that the FDA has extended the review period for the VP-102 NDA as the regulatory body needs additional time to review the requested data submitted in February.
Apart from molluscum, Verrica is also developing the candidate as a potential treatment for common warts and external genital warts in mid-stage clinical studies. The company is planning a phase II study on its another pipeline candidate, VP-103, as a potential treatment for plantar warts. It plans to submit an investigational new drug application for its pre-clinical candidate, LTX-315, in the second half of 2021 to evaluate it in malignant and pre-malignant dermatological indications.
Verrica Pharmaceuticals Inc. Price
Verrica Pharmaceuticals Inc. price | Verrica Pharmaceuticals Inc. Quote
Zacks Rank & Stocks to Consider
Verrica currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Xencor, Inc. (XNCR - Free Report) , Organogenesis Holdings Inc. (ORGO - Free Report) and Zoetis Inc. (ZTS - Free Report) , all carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Xencor’s loss per share estimates have narrowed 34% for 2021 over the past 30 days.
Organogenesis’ earnings per share estimates have increased 200% for 2021 over the past 30 days. The stock has jumped 136.8% so far this year.
Zoetis’ earnings per share estimates have moved 1.6% north for 2021 over the past 30 days.
Zacks' Top Picks to Cash in on Artificial Intelligence
In 2021, this world-changing technology is projected to generate $327.5 billion in revenue. Now Shark Tank star and billionaire investor Mark Cuban says AI will create "the world's first trillionaires." Zacks' urgent special report reveals 3 AI picks investors need to know about today.
See 3 Artificial Intelligence Stocks With Extreme Upside Potential>>