Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, announced on Tuesday 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), 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 30 December 2026.

This moves SL1009 into its second FDA review cycle following the original NDA submission in November 2024 and the issuance of a Complete Response Letter (CRL) in August 2025. The CRL did not identify any concerns related to the safety profile or manufacturing of SL1009. Saol resubmitted the NDA on 30 June 2026, after a productive Type A meeting in December 2025 and a Type C meeting in March 2026. During these meetings, the FDA advised Saol to conduct additional survival analyses to support the application, which Saol provided.

SL1009 has received Priority Review, Orphan Drug Designation and Rare Pediatric Disease Designation, and Saol anticipates receiving a Priority Review Voucher (PRV) under the Rare Pediatric Disease Statute upon approval.

If approved, SL1009 will be used with a proprietary dose-determining genetic test to treat PDCD, an orphan paediatric-onset mitochondrial disease.

In collaboration with Medosome Biotec, Saol will be filing a 510K for the dose-determining genetic test that will serve as a required companion diagnostic for patients treated with SL1009.