(RTTNews) - Verrica Pharmaceuticals Inc. (VRCA) a dermatology therapeutics company, announced on Friday that its partner, Torii Pharmaceutical Co. Ltd., has submitted a New Drug Application seeking approval of TO-208 for the treatment of Molluscum Contagiosum in Japan.
Molluscum contagiosum is a common, highly contagious skin disease that primarily affects children.
TO-208 is marketed under the brand name YCANTH in the U.S., following regulatory approval last July, and is the first FDA-approved treatment for molluscum.
TO-208 is a topical treatment containing cantharidin as the active ingredient. It is delivered via a single-use applicator for precise dosing and works by causing the infected skin cells to blister and eventually fall off.
The drug has demonstrated efficacy and safety in clinical trials, making it a potential first-line treatment for this highly contagious skin condition.
The NDA submission follows successful Phase 3 clinical trials in Japan, where TO-208 demonstrated superior efficacy compared to the vehicle, with a safety profile consistent with earlier studies in the U.S.
Verrica signed an exclusive license agreement with Torii in March 2021 for the development and commercialization of TO-208 to treat molluscum and common warts in Japan.
Verrica's CEO, Kelly Martin, noted that the NDA submission represents a major step forward in expanding YCANTH's reach to international markets.
VRCA closed Thursday's (Dec. 05, 2024) trading at $1.06, down 10.92%. In premarket trading today, the stock is up 5.61% at $1.11.
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