Posted by Michael Wonder on 29 Jul 2026
Saol Therapeutics announces the acceptance of resubmission of SL1009 by the FDA with PDUFA Date of 30 December 2026
28 July 2026 - Saol Therapeutics today announced that the US FDA has acknowledged the company's resubmission of its new drug application for SL1009, sodium dichloroacetate, for the treatment of pyruvate dehydrogenase complex deficiency, 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 PDUFA target action date of 30 December 2026.
