Clinical Data Supporting Dosing And TolerabilityPhase 2b PROGRESS results that identified a once-daily dose with meaningful pain reduction, placebo-like completion rates, and a generally well-tolerated safety profile increase confidence in success for upcoming pivotal trials.
Commercial Expansion And Broader IndicationsCommercial launch of INPEFA in new markets combined with planned regulatory filings in additional countries and a diversified late-stage pipeline offer multiple avenues for new revenue beyond core regions.
Regulatory Progress For PilavapadinFavorable End-of-Phase-2 feedback and absence of unexpected study requirements from the FDA enable advancement of pilavapadin into pivotal diabetic peripheral neuropathic pain studies, supporting a clearer path toward potential registration.