FDA confirmed the resubmission is a complete, Class II response to the Aug. 27, 2025 CRL.
Saol remains committed to working with FDA toward approval of this treatment for PDCD, a rare, life-threatening mitochondrial disease with no approved therapies.
ROSWELL, Ga. and DUBLIN and HAMILTON, Bermuda, July 28, 2026 /PRNewswire/ -- Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, today announced that the U.S. 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 Dec. 30, 2026.
The acknowledgement moves SL1009 into its second FDA review cycle following the original NDA submission on Nov. 27, 2024, and the issuance of a Complete Response Letter (CRL) on Aug. 27, 2025. The CRL did not identify any concerns related to the safety profile or manufacturing of SL1009. Saol resubmitted the NDA on June 30, 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.
"Having a confirmed action date matters greatly to the families of children living with PDCD, who have waited a long time for a potential treatment option," said Dave Penake, chief executive officer of Saol Therapeutics. "We remain confident in the totality of evidence behind SL1009 and what it can mean for these patients."
Penake added, "We're grateful to the patients, families, investigators and clinicians who have carried this program forward, and to the FDA for its continued partnership throughout this process."
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.
About SL1009, Sodium Dichloroacetate (DCA)
SL1009 is an investigational product that, if approved, will be used with a proprietary dose-determining genetic test to treat an orphan pediatric-onset mitochondrial disease, Pyruvate Dehydrogenase Complex Deficiency (PDCD). PDCD is a rare and life-threatening genetic disorder that can cause chronic energy deficit leading to lactic acidosis, profound developmental problems, and early childhood death. There are currently no FDA-approved therapies for PDCD.
SL1009 has received Priority Review, Orphan Drug Designation and Rare Pediatric Disease Designation. Saol, in collaboration with Medosome Biotec, will be filing a 510K for the dose-determining genetic test that will serve as a required companion diagnostic for patients treated with SL1009.
About Saol Therapeutics
Saol Therapeutics (pronounced "Sail") is a privately held, clinical-stage, pharmaceutical company with operations in Roswell, Ga., Dublin, Ireland, and Hamilton, Bermuda. Saol is focused on development activity in CNS disorders such as spasticity and pain management, and orphan diseases. Saol is committed to providing and advancing therapeutic options for patients and the physicians treating these populations. For more information, visit www.saolrx.com.
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