Analysts Still Believe Verrica's Ycanth Is Approvable Despite FDA Response Letter

  • Verrica Pharmaceuticals Inc VRCA held a Type A meeting with the FDA regarding the path forward for the resubmission and potential approval of Ycanth (VP-102) for molluscum contagiosum.
  • HC Wainwright says VP-102 was approvable, and at the time of the Complete Response Letter (CRL), Verrica had already engaged a potential alternate solution supplier. 
  • It reiterates the Buy rating, with a price target of $12.
  • FDA told Verrica that rather than a typical three lots and six-month stability, Verrica could submit one single lot of finished goods with accelerated 3-month stability and potentially refile the application 
  • HC Wainwright views this as highly encouraging that the FDA is working collaboratively with Verrica. 
  • Assuming no surprises in the FDA meeting expected in late July, tech transfer and manufacturing are expected to proceed as fast as possible. 
  • The analysts pushed resubmission toward mid-2023 and 6-month review taking approval out to late-2023 with early-2024 launch. 
  • HC Wainwright still sees over $300 million in peak U.S. sales potential.
  • Needham says Verrica should provide a more detailed update when meeting minutes become available. 
  • It says that though Ycanth is an approvable product with a promising commercial future, Needham remains at a Hold rating given the uncertain timelines for VP-102 marketing application resubmission.
  • Price Action: VRCA shares are up 6.44% at $2.18 during the market session on the last check Wednesday.

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