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.

Posted In: BriefsAnalyst ColorBiotechNewsPenny StocksHealth CareFDAAnalyst RatingsGeneral

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on Bankrate.com. The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the Bankrate.com rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.