Saol Therapeutics Announces the Acceptance of Resubmission of SL1009 (DCA) by the FDA with PDUFA Date of Dec. 30, 2026
Saol Therapeutics Announces the Acceptance of Resubmission of SL1009 (DCA) by the FDA with PDUFA Date of Dec. 30, 2026.
Saol Therapeutics
Private
Roswell, GA-based rare disease biotech developing therapies for pain, osteoarthritis, spasticity, and mitochondrial disorders, with a strategic focus on underserved CNS indications.
Company Info
Upcoming Milestones & Key Dates
2026-07-07
regulatory
SL1009 NDA resubmission acknowledged by FDA
2027-H1
regulatory
Expected FDA action on SL1009 NDA
Clinical Development Pipeline
SL1009 (dichloroacetate)
Target: Pyruvate dehydrogenase kinase inhibitorUndisclosed
Target: CNS pathwayUndisclosed
Target: Mitochondrial functionRecent News
Saol boards FDA’s resubmission boat, armed with new survival data
Saol boards FDA’s resubmission boat, armed with new survival data (BioSpace.)
Saol Therapeutics Resubmits the New Drug Application for SL1009 (DCA) for the Treatment of Pyruvate Dehydrogenase Complex Deficiency (PDCD), an Ultra-Rare Disease
Saol Therapeutics Resubmits the New Drug Application for SL1009 (DCA) for the Treatment of Pyruvate Dehydrogenase Complex Deficiency (PDCD), an Ultra-Rare Disease (reported by PR Newswire)
Leadership Team
David R. McClung
Chief Executive Officer