Saol Therapeutics Resubmits NDA for PDCD Treatment SL1009

The resubmission marks a critical milestone for the drug, known as sodium dichloroacetate, which aims to address a condition currently lacking any FDA-approved therapies. After receiving a Complete Response Letter in August 2025, Saol engaged in Type A and Type C meetings with the agency to refine its data package. These discussions focused on existing clinical evidence, including functional outcomes and long-term safety data from two Phase 3 studies, rather than requiring additional patient enrollment.

Dave Penake, CEO of Saol Therapeutics, credited the progress to the FDA's willingness to apply regulatory flexibility for life-threatening, ultra-rare conditions. The company is simultaneously pursuing a Humanitarian Device Exemption for a proprietary genetic test developed with Medosome Biotec, which serves as a companion diagnostic for the treatment. If approved, SL1009 stands to benefit from Orphan Drug and Rare Pediatric Disease designations, potentially qualifying the company for a Priority Review Voucher.