FDA acknowledges Saol’s resubmission for SL1009

Privately held, US clinical-stage pharma Saol Therapeutics announced that the US Food and Drug Administration (FDA) has acknowledged the company's resubmission of its New Drug Application (NDA) for SL1009, sodium dichloroacetate (DCA).

The investigational drug is for the treatment of pyruvate dehydrogenase complex deficiency (PDCD), a rare, life-threatening mitochondrial disease with no FDA-approved therapies. The FDA acknowledged the resubmission as complete, classified it as Class 2, and set a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2026.