FDA verified that the resubmission represents a full Class II reply to the Aug. 27 2025 CRL.
Saol continues its dedication to collaborating with the FDA on securing approval for this therapy aimed at PDCD, an uncommon and serious mitochondrial condition lacking any authorized treatments.

/PRNewswire/ -- Saol Therapeutics, a privately held clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration has recognized the firm's resubmission of its New Drug Application for SL1009, sodium dichloroacetate, intended to treat pyruvate dehydrogenase complex deficiency, a rare and serious mitochondrial disorder without any FDA-cleared options. The agency deemed the resubmission complete, labeled it Class 2, and assigned a Prescription Drug User Fee Act target action date of Dec. 30 2026.

This recognition places SL1009 into its next FDA evaluation phase after the initial NDA filing on Nov. 27 2024 and the Complete Response Letter issued on Aug. 27 2025. The CRL raised no issues regarding the safety data or production process for SL1009. Saol delivered the updated NDA on June 30 2026 following constructive Type A and Type C meetings held in December 2025 and March 2026. In those sessions the FDA recommended further survival data analyses, which the company supplied.

"A confirmed action date holds real importance for families of children affected by PDCD who have sought a viable treatment for an extended period," said Dave Penake, chief executive officer of Saol Therapeutics. "We stay assured in the complete body of evidence supporting SL1009 and the benefits it may deliver to these patients."

Penake continued, "We appreciate the patients, families, investigators and clinicians who have advanced this effort, along with the FDA for its ongoing collaboration during this review."

SL1009 holds Priority Review, Orphan Drug Designation and Rare Pediatric Disease Designation. Saol expects to obtain a Priority Review Voucher under the Rare Pediatric Disease Statute if approval is granted.

About SL1009, Sodium Dichloroacetate

SL1009 is an investigational therapy that, if cleared, would pair with a proprietary genetic test to address an orphan pediatric mitochondrial disorder known as Pyruvate Dehydrogenase Complex Deficiency. PDCD is an uncommon genetic condition that may produce ongoing energy shortfalls, lactic acidosis, severe developmental delays and early childhood mortality. No FDA-approved treatments exist for PDCD at present.

SL1009 carries Priority Review, Orphan Drug Designation and Rare Pediatric Disease Designation. Saol, working with Medosome Biotec, plans to submit a 510K application for the companion genetic test required for dosing decisions in patients receiving SL1009.

About Saol Therapeutics

Saol Therapeutics is a privately held clinical-stage pharmaceutical company operating from Roswell, Ga., Dublin, Ireland, and Hamilton, Bermuda. The firm concentrates on CNS conditions including spasticity and pain control as well as orphan disorders. Saol is devoted to developing and delivering treatment choices for patients and the clinicians who serve these groups. Additional details are available at www.saolrx.com.

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SOURCE Saol Therapeutics