Drug Development And Market PotentialOxylanthanum carbonate has shown non-inferiority to Fosrenol in prior studies and offers an easier administration with a low pill burden, potentially improving patient compliance and capturing a significant market share.
Financial Stability And FundingThe company's cash runway extends into 2026, ensuring financial stability and support for the completion of crucial trials and potential FDA approval processes.
Regulatory Milestone And Market OpportunityPositive top-line data from the pivotal trial would enable an NDA submission for oxylanthanum carbonate, positioning the company to benefit from the Transitional Drug Add-On Payment Adjustment starting January 1, 2025.