Verrica Pharmaceuticals · VP-102 · 2022 – 2026
What is the securities class action against Verrica about?
Filed in June 2022, after the third letter, it alleges that manufacturing deficiencies at the contract manufacturer's facility were not disclosed. Claims over statements made in May and June 2021 survived; a class was certified in March 2026.
EphemerisX Research · Published · 5 source documents · 2 min read
Short answer
According to Verrica's 10-K, the amended complaint alleges that the defendants did not disclose manufacturing deficiencies at the facility where the contract manufacturer produced VP-102's bulk solution, and that those deficiencies put approval at risk. The class period runs from May 19, 2021 to May 24, 2022, the day Verrica announced the third letter. The court let claims over statements made in May and June 2021 proceed and certified the class on March 4, 2026.
What the evidence shows
The 10-K: On June 6, 2022, plaintiff Kranthi Gorlamari, or Plaintiff, filed a putative class action complaint
10-K · Mar 11, 2026. The amended complaint alleges violations by, among other things, failing to disclose certain manufacturing deficiencies at the facility where our contract manufacturer produced bulk solution for the YCANTH (VP-102) drug device and that such deficiencies posed a risk to the prospects for regulatory approval
10-K · Mar 11, 2026. It covers investors who bought between May 19, 2021 and May 24, 2022
10-K · Mar 11, 2026.
The period ends on the day of Verrica's announcement of the third letter: the Company’s announcement on May 24, 2022 of the receipt by the Company of a complete response letter
8-K · Jun 3, 2022.
The court: The Court held that Plaintiff’s claims relating to statements made in May and June 2021 were sufficiently pled, but dismissed Plaintiff’s claims relating to all other statements made during the Putative Class Period.
10-K · Mar 11, 2026 Then: On March 4, 2026, the Court granted Plaintiff's motion for class certification.
10-K · Mar 11, 2026
What Verrica's filings said about the facility inside the class period. September 2021: The identified deficiencies do not specifically relate to the manufacturing of VP-102, but instead raise general quality issues at the facility.
8-K · Sep 20, 2021 November 2021: the classification will not directly negatively impact FDA’s assessment of the Company’s NDA regarding this CMO
8-K · Nov 12, 2021. May 2022: as a direct result of deficiencies identified at a general reinspection of a facility of Sterling Pharmaceutical Services, LLC
8-K · May 25, 2022.
The 2026 10-K names neither Sterling nor Piramal, and does not mention human factors, a Type A meeting or a CRL. 10-K · searched This record holds no Verrica filing from May or June 2021, the months whose statements the court let proceed.
Follow the thread
- Why did the FDA's second letter turn on a contract manufacturer's facility?“General quality issues at the facility”
- What changed between Verrica's second and third FDA letters?A “general reinspection” of Sterling's facility
- How did VP-102 get from a third FDA letter to approval in July 2023?The 10-K names neither manufacturer
This investigation connects to
- What happens after a second FDA Complete Response Letter?Cross-investigation · Divergent outcome · with Aldeyra Therapeutics, CorMedix, Outlook Therapeutics, Replimune
- What happens when an FDA letter turns on a contract manufacturer, not the drug?Cross-investigation · Shared concern · with CorMedix
- What did “no efficacy or safety issues” cover in these FDA letter announcements?Cross-investigation · Shared concern · with CorMedix, Replimune
The documents, by date
The passages quoted
Verrica Pharmaceuticals Form 8-K, filed September 20, 2021
announced that it received a complete response letter from the U.S. Food and Drug Administration (the “ FDA ”) identifying deficiencies at a facility of a contract manufacturing organization for its New Drug Application (the “ NDA ”) for VP-102 for the treatment of molluscum contagiosum. The identified deficiencies do not specifically relate to the manufacturing of VP-102, but instead raise general quality issues at the facility. The FDA did not identify any clinical, safety or product specific chemistry, manufacturing, and controls deficiencies related to the NDA.Open at the source →
Verrica Pharmaceuticals Form 8-K, filed November 12, 2021
On November 5, 2021, Verrica was notified that the inspection of the CMO has been classified as “voluntary action indicated” (“VAI”), is now closed and that the VAI classification will not directly negatively impact FDA’s assessment of the Company’s NDA regarding this CMO. With the satisfactory resolution of the facility inspection, Verrica has engaged the FDA to determine the next steps toward the potential approval of VP-102 for the treatment of molluscum.Open at the source →
Verrica Pharmaceuticals Form 8-K, filed May 25, 2022
announced that it received a complete response letter (“ CRL ”) from the U.S. Food and Drug Administration (the “ FDA ”) as a direct result of deficiencies identified at a general reinspection of a facility of Sterling Pharmaceutical Services, LLC (“ Sterling ”), a contract manufacturing organization for its New Drug Application (the “ NDA ”) for VP-102 for the treatment of molluscum contagiosum. The CRL did not identify any other deficiencies. Sterling advised the Company that it received notice on May 19, 2022 that it is on Official Action Indicated (“ OAI ”) status. None of the issues identified by FDA during the reinspection were specific to the manufacturing of VP-102. The Company was informed by the FDA that it had completed its review of the NDA and product label, there were no open questions on the NDA review, and the VP-102 label was ready to be communicated.Open at the source →
Verrica Pharmaceuticals Form 8-K, filed June 3, 2022
On May 31, 2022, the board of directors (the “Board”) of Verrica Pharmaceuticals Inc. (the “Company”), in order to streamline operations and reduce costs, approved a plan to reduce its workforce by terminating 20 employees, which the Company expects to be completed by June 3, 2022. The decision followed the Company’s announcement on May 24, 2022 of the receipt by the Company of a complete response letter for its new drug application for VP-102.Open at the source →
Verrica Pharmaceuticals Form 10-K, filed March 11, 2026
The 2026 10-K names neither Sterling nor Piramal, and does not mention human factors, a Type A meeting or a CRL.
Open the document →Verrica Pharmaceuticals Form 10-K, filed March 11, 2026
On March 4, 2026, the Court granted Plaintiff's motion for class certification.Open at the source →
Verrica Pharmaceuticals Form 10-K, filed March 11, 2026
On January 12, 2024, the Court granted in part and denied in part Defendants’ motion to dismiss the amended complaint. The Court held that Plaintiff’s claims relating to statements made in May and June 2021 were sufficiently pled, but dismissed Plaintiff’s claims relating to all other statements made during the Putative Class Period.Open at the source →
Verrica Pharmaceuticals Form 10-K, filed March 11, 2026
On June 6, 2022, plaintiff Kranthi Gorlamari, or Plaintiff, filed a putative class action complaint captioned Gorlamari v. Verrica Pharmaceuticals Inc., et al., in the U.S. District Court for the Eastern District of Pennsylvania against 69 Table of Contents us and certain of our current and former officers and directors, or Defendants. On January 12, 2023, the Plaintiff filed an amended complaint alleging that Defendants violated federal securities laws by, among other things, failing to disclose certain manufacturing deficiencies at the facility where our contract manufacturer produced bulk solution for the YCANTH (VP-102) drug device and that such deficiencies posed a risk to the prospects for regulatory approval of YCANTH (VP-102) for the treatment of molluscum. The amended complaint seeks unspecified compensatory damages and other relief on behalf of Plaintiff and all other persons and entities which purchased or otherwise acquired our securities between May 19, 2021 and May 24, 2022, or the Putative Class Period.Open at the source →