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- 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.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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