|Over a week ago|
Verrica Pharmaceuticals price target lowered to $12 from $20 at H.C. Wainwright » 07:3805/3105/31/22
H.C. Wainwright analyst…
H.C. Wainwright analyst Oren Livnat lowered the firm's price target on Verrica Pharmaceuticals to $12 from $20 and keeps a Buy rating on the shares after the company received a third Complete Response Letter for VP-102, a topical cantharidin drug-device for molluscum contagiosum. The analyst thinks moving to a new supplier is the likely course and still sees ultimate approval, 18 months later than expected.
|Over a month ago|
Verrica Pharmaceuticals downgraded to Hold at Needham after CRL » 11:3605/2505/25/22
Needham analyst Serge…
Needham analyst Serge Belanger downgraded Verrica Pharmaceuticals to Hold from Buy and removed his previous price target on the shares after the company announced that the FDA has issued a Complete Response Letter regarding its New Drug Application for VP-102 for the treatment of molluscum contagiosum. This is the third CRL from the FDA for VP-102 and second CRL where CMO deficiencies at Sterling Pharmaceuticals prevented the agency from approving the product, noted Belanger. While Verrica is engaging a new CMO, there is likely to be a lengthy process to refiling and a delay of at least 12-months for FDA approval, said the analyst. While Belanger believes VP-102 has "a bright commercial future," Verrica's financing overhang is "now more difficult to address," the analyst added.
Verrica Pharmaceuticals downgraded to Hold from Buy at Needham » 11:3005/2505/25/22
Needham analyst Serge…
Needham analyst Serge Belanger downgraded Verrica Pharmaceuticals to Hold from Buy.
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Check out this morning's…
Verrica downgraded to Sector Perform from Outperform at RBC Capital » 05:1305/2505/25/22
RBC Capital analyst…
RBC Capital analyst Gregory Renza downgraded Verrica Pharmaceuticals to Sector Perform from Outperform with a price target of $4, down from $16, after the company received a Complete Response Letter from the FDA regarding its New Drug Application for VP-102 for the treatment of molluscum contagiosum. General contract manufacturing organization challenges continue to plague the filing, again standing in the way of an approval, Renza tells investors in a research note. The analyst downgrades the shares citing new uncertainty post the CRL.
Verrica Pharma gets FDA CRL for VP-102 in molluscum contagiosum treatment » 20:1405/2405/24/22
Verrica Pharmaceuticals "announced that the FDA has issued a Complete Response Letter regarding its New Drug Application for VP-102 for the treatment of molluscum contagiosum. The only deficiency listed in the CRL was related to the deficiencies identified at a general reinspection of Sterling Pharmaceuticals Services, LLC, the contract manufacturing organization that manufactures Verrica's bulk solution drug product. Sterling advised Verrica on May 20, 2022 that it received notice that it is on OAI status. Sterling's OAI classification resulted from a week-long reinspection of the CMO conducted by FDA in February 2022. The reinspection was conducted approximately 90 days after Sterling was originally classified by the Agency as VAI on November 17, 2021. Verrica understood that the VAI classification did not indicate that a reinspection was required. The CRL did not identify any other deficiencies. Moreover, none of the issues identified by FDA during the reinspection were specific to the manufacturing of VP-102. Additionally, Verrica was informed by the Division that it had completed its review of Verrica's NDA and product label, there were no open questions on the NDA review, and the VP-102 label was ready to be communicated. However, Verrica has been informed that internal FDA policy is preventing the Agency from communicating the label and approving the NDA when a CMO has an unresolved classification status or is placed on OAI status."
Verrica Pharmaceuticals reports Q1 EPS (31c), consensus (47c) » 07:3205/0905/09/22
Reports Q1 revenue…
Reports Q1 revenue $431,000, consensus $260,000. "This quarter, we achieved commercial readiness and entered the final stage of pre-launch operations as our PDUFA date approaches for VP-102, potentially the first treatment approved by the FDA to treat molluscum," said Ted White, Verrica's President and Chief Executive Officer. "We look forward to potentially bringing treatment and relief to thousands of patients, primarily children, suffering from molluscum, starting with a sales focus in Dermatology, Pediatric Dermatology and key academic centers and health systems." White continued: "We also dosed the first patient in our Phase 2 trial of LTX-315, a novel immunotherapy, in basal cell carcinoma, the most common type of cancer in the world. We are excited about this innovative, non-surgical approach to non-melanoma skin cancers. We expect to enroll over 60 patients in the trial and look forward to providing further updates."