Saol Therapeutics Resubmits NDA for PDCD Treatment SL1009
Saol Therapeutics has resubmitted its New Drug Application to the FDA for SL1009, a potential treatment for the rare mitochondrial disorder pyruvate dehydrogenase complex deficiency. The move follows months of regulatory dialogue that allowed the company to bypass new clinical trials in favor of supplemental survival analysis.
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.
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