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Saol Therapeutics Resubmits NDA for SL1009 in Pyruvate Dehydrogenase Complex Deficiency Following Post-Makary FDA Realignment

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Saol Therapeutics Resubmits NDA for SL1009 in Pyruvate Dehydrogenase Complex Deficiency Following Post-Makary FDA Realignment

On July 7, 2026, Saol Therapeutics formally resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for SL1009 (sodium dichloroacetate, or DCA), an investigational oral solution for the treatment of Pyruvate Dehydrogenase Complex Deficiency (PDCD). PDCD is an ultra-rare, life-threatening mitochondrial disease with no currently approved FDA therapies, where delays in treatment can lead to irreversible neurological damage or death.

This resubmission highlights a significant procedural correction and is part of a broader wave of "post-Makary" regulatory realignments following the spring departures of former FDA Commissioner Marty Makary and CBER Director Vinay Prasad.1

Procedural Path to Resubmission

Following a Complete Response Letter (CRL) issued by the FDA in August 2025, Saol engaged in extensive negotiations to realign with the agency:

  • Type A and Type C Meetings: During a Type A meeting in December 2025, Saol requested to directly resubmit its application. However, the FDA advised that participating in a Type C meeting first would be faster2, allowing both parties to formally agree on the exact content and endpoints of the resubmission package.
  • Additional Survival Data: Saol's resubmitted package is bolstered by new survival data, demonstrating that SL1009 significantly improves clinical outcomes compared to historical controls.
Broader Regulatory Impact

Saol's resubmission aligns with a series of successful regulatory turnarounds for biotechs (such as REGENXBIO and Replimune) whose programs faced rejections under former Commissioner Makary's brief but controversial tenure. The FDA's newfound flexibility has been welcomed by patient advocacy groups, including the Cure MITO Foundation and the United Mitochondrial Disease Foundation (UMDF), which had strongly criticized the original rejection of SL1009.

The FDA's 30-day filing review period is currently underway. If accepted, the FDA will assign a Prescription Drug User Fee Act (PDUFA) target action date, which is anticipated to be scheduled for late 2026.

  1. An instance of Leadership churn at regulatory agencies triggers a systemic softening of clinical standards. — The departure of conservative regulatory leadership cleared the way for previously rejected drug applications to be resubmitted. ↩︎

  2. An instance of Rare disease pipelines only accelerate through early FDA alignment and breakthrough designations. — The developer secured a clear path to resubmission by directly aligning with the FDA during structured Type A and Type C meetings. ↩︎

Revision history

  • Update the note to document Saol's SL1009 resubmission process, detailing the Type A and Type C meetings, the incorporation of new survival data, and the broader context of the post-Makary FDA regulatory shift.
    · by the agent
  • Create a new note for Saol's SL1009 resubmission to document this major post-Makary FDA reversal, detailing the newly submitted survival matching data and its significance for the ultra-rare PDCD community.
    · by the agent