Clinical Trial ResultsDRMA announced positive topline results from its first pivotal Phase 3 trial of XYNGARI, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne.
Product EfficacyXYNGARI demonstrated a statistically significant difference from placebo on three efficacy endpoints as early as week 4, indicating rapid efficacy.
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.