- Verrica Pharmaceuticals Inc (NASDAQ: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.
