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Verrica (VRCA) Down 64% as Molluscum Drug Gets CRL From FDA
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Verrica Pharmaceuticals (VRCA - Free Report) announced that the FDA has issued a complete response letter (CRL) to its new drug application (NDA), which seeks approval for its lead product candidate, VP-102, to treat molluscum contagiosum (molluscum), a highly contagious skin disease.
Per the CRL, the FDA identified deficiencies at a general reinspection of Sterling Pharmaceuticals Services, LLC. Sterling is VRCA’s contract manufacturing organization (CMO), which manufactures the latter’s bulk solution of VP-102.
Last week, Verrica was notified that Sterling is currently being classified under an OAI (Official Action Indicated) status, based on an FDA-conducted inspection earlier this February. The FDA’s internal policies prevent it from approving an NDA and communicating the drug’s label if the CMO is placed under an OAI status.
Per Verrica, the CRL did not identify any other deficiency apart from the one mentioned above. In fact, none of the deficiencies pertain to manufacturing operations for VP-102. There were also no open questions on VP-102’s regulatory filing mentioned in the CRL.
Per management, Sterling was placed under the OAI status on the possible grounds of manufacturing higher-risk sterile ophthalmic products for the United States government.
Based on the response received in the CRL, Verrica plans to file for a Type A meeting request with the FDA officials by the end of this week. VRCA will also coordinate with Sterling and the FDA to quickly resolve the deficiencies highlighted in the CRL. VRCA is also planning to engage an additional CMO to manufacture VP-102’s bulk solution.
Shares of Verrica plunged 63.9% on May 25 following the above announcement. The stock has slumped 78.1% so far this year compared with the industry’s 25.5% decline.
Image Source: Zacks Investment Research
If approved, VP-102 will be the first FDA-approved drug for treating molluscum. Currently, there are no approved medications to treat the said indication. Management plans to market the drug under the trade name Ycanth.
The NDA filing with the FDA was based on positive data from two pivotal phase III studies, namely CAMP-1 and CAMP-2, which evaluated the safety and efficacy of VP-102 over placebo in participants aged two years and above and diagnosed with molluscum. Both studies achieved their primary endpoint of complete clearance of all treatable molluscum lesions at the end of the regime.
This is the second CRL received by Verrica for the VP-102 NDA. The first CRL was received last September regarding a deficiency identified by the FDA following a general inspection of Sterling. Like the current CRL, the previous one also did not identify any flaws pertaining to the manufacturing of VP-102. Following the receipt of the first CRL, the FDA classified Sterling as the Voluntary Action Indicated (VAI).
Per the FDA, a CMO classified as VAI means that objectionable conditions or practices were found but the agency is not yet prepared to take or recommend any administrative or regulatory action.
Apart from mollusum, Verrica is developing VP-102 to treat common warts and external genital warts. VRCA also successfully completed two separate mid-stage studies evaluating the candidate for these indications.
Abeona Therapeutics’ loss per share estimates for 2022 have narrowed from 33 cents to 31 cents in the past 30 days. The same for 2023 has narrowed from 15 cents to 13 cents in the past 30 days. Shares of ABEO have declined 54.5% in the year-to-date period.
Earnings of Abeona Therapeutics missed estimates in two of the trailing four quarters and met the same on the remaining two occasions, the average negative surprise being 8.2%. In the last reported quarter, Abeona Therapeutics missed on earnings by 25%.
Alkermes’ loss per share estimates for 2022 have narrowed from 10 cents to 3 cents in the past 30 days. Shares of ALKS have risen 24% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%. In the last reported quarter, Alkermes delivered an earnings surprise of 1,100%.
Angion Biomedica’s loss per share estimates for 2023 have narrowed from $2.19 to $2.07 in the past 30 days. Shares of ANGN have plunged 56.6% in the year-to-date period.
Earnings of Angion Biomedica beat estimates in three of the last four quarters and missed the mark once, the average surprise being 58.1%. In the last reported quarter, Angion Biomedica missed on earnings by 9.1%.
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Verrica (VRCA) Down 64% as Molluscum Drug Gets CRL From FDA
Verrica Pharmaceuticals (VRCA - Free Report) announced that the FDA has issued a complete response letter (CRL) to its new drug application (NDA), which seeks approval for its lead product candidate, VP-102, to treat molluscum contagiosum (molluscum), a highly contagious skin disease.
Per the CRL, the FDA identified deficiencies at a general reinspection of Sterling Pharmaceuticals Services, LLC. Sterling is VRCA’s contract manufacturing organization (CMO), which manufactures the latter’s bulk solution of VP-102.
Last week, Verrica was notified that Sterling is currently being classified under an OAI (Official Action Indicated) status, based on an FDA-conducted inspection earlier this February. The FDA’s internal policies prevent it from approving an NDA and communicating the drug’s label if the CMO is placed under an OAI status.
Per Verrica, the CRL did not identify any other deficiency apart from the one mentioned above. In fact, none of the deficiencies pertain to manufacturing operations for VP-102. There were also no open questions on VP-102’s regulatory filing mentioned in the CRL.
Per management, Sterling was placed under the OAI status on the possible grounds of manufacturing higher-risk sterile ophthalmic products for the United States government.
Based on the response received in the CRL, Verrica plans to file for a Type A meeting request with the FDA officials by the end of this week. VRCA will also coordinate with Sterling and the FDA to quickly resolve the deficiencies highlighted in the CRL. VRCA is also planning to engage an additional CMO to manufacture VP-102’s bulk solution.
Shares of Verrica plunged 63.9% on May 25 following the above announcement. The stock has slumped 78.1% so far this year compared with the industry’s 25.5% decline.
Image Source: Zacks Investment Research
If approved, VP-102 will be the first FDA-approved drug for treating molluscum. Currently, there are no approved medications to treat the said indication. Management plans to market the drug under the trade name Ycanth.
The NDA filing with the FDA was based on positive data from two pivotal phase III studies, namely CAMP-1 and CAMP-2, which evaluated the safety and efficacy of VP-102 over placebo in participants aged two years and above and diagnosed with molluscum. Both studies achieved their primary endpoint of complete clearance of all treatable molluscum lesions at the end of the regime.
This is the second CRL received by Verrica for the VP-102 NDA. The first CRL was received last September regarding a deficiency identified by the FDA following a general inspection of Sterling. Like the current CRL, the previous one also did not identify any flaws pertaining to the manufacturing of VP-102. Following the receipt of the first CRL, the FDA classified Sterling as the Voluntary Action Indicated (VAI).
Per the FDA, a CMO classified as VAI means that objectionable conditions or practices were found but the agency is not yet prepared to take or recommend any administrative or regulatory action.
Apart from mollusum, Verrica is developing VP-102 to treat common warts and external genital warts. VRCA also successfully completed two separate mid-stage studies evaluating the candidate for these indications.
Verrica Pharmaceuticals Inc. Price
Verrica Pharmaceuticals Inc. price | Verrica Pharmaceuticals Inc. Quote
Zacks Rank & Other Stocks to Consider
Verrica currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the overall healthcare sector are Abeona Therapeutics , Alkermes (ALKS - Free Report) and Angion Biomedica , each of which has a Zacks Rank of 2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Abeona Therapeutics’ loss per share estimates for 2022 have narrowed from 33 cents to 31 cents in the past 30 days. The same for 2023 has narrowed from 15 cents to 13 cents in the past 30 days. Shares of ABEO have declined 54.5% in the year-to-date period.
Earnings of Abeona Therapeutics missed estimates in two of the trailing four quarters and met the same on the remaining two occasions, the average negative surprise being 8.2%. In the last reported quarter, Abeona Therapeutics missed on earnings by 25%.
Alkermes’ loss per share estimates for 2022 have narrowed from 10 cents to 3 cents in the past 30 days. Shares of ALKS have risen 24% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%. In the last reported quarter, Alkermes delivered an earnings surprise of 1,100%.
Angion Biomedica’s loss per share estimates for 2023 have narrowed from $2.19 to $2.07 in the past 30 days. Shares of ANGN have plunged 56.6% in the year-to-date period.
Earnings of Angion Biomedica beat estimates in three of the last four quarters and missed the mark once, the average surprise being 58.1%. In the last reported quarter, Angion Biomedica missed on earnings by 9.1%.