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VERRICA PHARMACEUTICALS INC.

(VRCA)
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Verrica Pharmaceuticals Shares Drop 17% After FDA Complete Response Letter

09/21/2021 | 11:11am EDT

By Chris Wack

Verrica Pharmaceuticals Inc. shares were down 17% to $9.99 after the company said the U.S. Food and Drug Administration has issued a Complete Response Letter regarding its New Drug Application for VP-102 for the treatment of molluscum contagiosum.

The company had previously disclosed that the FDA extended the Prescription Drug User Fee Act goal date for the NDA by three months to this Thursday, to allow the FDA additional time to review information in response to comments regarding the company's human factors study.

According to the CRL, the FDA has identified deficiencies at a facility of a contract manufacturing organization, which are not specifically related to the manufacturing of VP-102 but instead raise general quality issues at the facility.

Verrica said that at no time prior to the CRL was it notified by the FDA of any deficiencies at the CMO related specifically to the manufacturing of VP-102 or that its general investigation of the facility would have any impact on the company's NDA. Also, the FDA didn't identify any clinical, safety or product specific chemistry, manufacturing and controls deficiencies related to VP-102.

The company said the CMO has implemented corrective actions to address the FDA's concerns, and the CMO has advised Verrica that it is expecting a satisfactory resolution of the facility's identified deficiencies from the FDA within the next 30 business days.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

09-21-21 1110ET

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Analyst Recommendations on VERRICA PHARMACEUTICALS INC.
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Financials (USD)
Sales 2021 9,80 M - -
Net income 2021 -44,9 M - -
Net Debt 2021 - - -
P/E ratio 2021 -8,22x
Yield 2021 -
Capitalization 357 M 357 M -
Capi. / Sales 2021 36,5x
Capi. / Sales 2022 10,4x
Nbr of Employees 29
Free-Float 35,9%
Chart VERRICA PHARMACEUTICALS INC.
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Verrica Pharmaceuticals Inc. Technical Analysis Chart | VRCA | US92511W1080 | MarketScreener
Technical analysis trends VERRICA PHARMACEUTICALS INC.
Short TermMid-TermLong Term
TrendsBullishNeutralNeutral
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus BUY
Number of Analysts 6
Last Close Price 12,99 $
Average target price 19,83 $
Spread / Average Target 52,7%
EPS Revisions
Managers and Directors
Ted White President, Chief Executive Officer & Director
Terry Kohler Chief Financial & Accounting Officer
Paul B. Manning Chairman
Gary Goldenberg Chief Medical Officer
Eugene Scavola Executive Vice President-Technical Operations
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