Clinical Trial SuccessXYNGARI met all three primary endpoints by achieving a statistically significant difference when compared with placebo after 12 weeks of once-weekly treatment.
Clinical UtilityThe additional positive P3 data reinforces belief in the efficacy of XYNGARI and gives additional confidence in the product's clinical utility ahead of the upcoming STAR-2 trial.
Regulatory StrategyThe strategic shift toward the FDA OTC monograph pathway is seen as a prudent move that should reduce time to market, regulatory hurdles, and capital requirements for commercializing Spongilla technology.