The Pharmaletter

One To Watch

Saol Therapeutics

A clinical-stage pharma company with operations in Roswell (GA), Dublin (Ireland), and Hamilton (Bermuda), dedicated to developing therapies for central nervous system and rare diseases, including orphan and pediatric conditions.

The company's lead drug, SL1009 (sodium dichloroacetate or DCA), is an oral solution paired with a proprietary genetic test. It targets pyruvate dehydrogenase complex deficiency (PDCD), a life-threatening mitochondrial disorder with no approved treatments. SL1009 has received Orphan Drug, Fast Track, Rare Pediatric Disease, and Priority Review designations from the FDA, and the NDA was accepted for review in early 2025.

In September 2025, Saol announced it had received a Complete Response Letter (CRL) from the FDA for SL1009—meaning the NDA cannot be approved in its current form. The agency outlined specific issues that must be addressed, with the company estimating resolution may take several years and require substantial financial investment.

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