Clinical Trials
5
3 active
Approvals
4
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
Active, not recruiting
3
60.0%
Available
1
20.0%
Recruiting
1
20.0%
- Saol Therapeutics will receive up to $115 million in milestone-based capital from funds managed by Oaktree, with an initial tranche funding near-term launch readiness for SL1009. - SL1009 (sodium dichloroacetate) is under FDA review for pyruvate dehydrogenase complex deficiency, with an NDA resubmission filed June 30, 2026 and a target action date of December 30, 2026. - Additional capital tied to regulatory, clinical and commercial milestones would support SL1009 development in congenital lactic acidosis and expansion of SL1002 into more pain indications and spasticity. - Saol also received a USPTO Notice of Allowance for a method of administering SL1009 after a ketogenic diet, with the patent anticipated to expire in 2045.
- An arbitration panel ruled in favor of Prime Medicine, determining the company does not owe Beam Therapeutics monetary damages in a dispute over rival AATD gene editing therapies. - Both companies originated from David Liu's labs and entered a 2019 collaboration that Beam claimed Prime breached by advancing its own AATD treatment. - Prime's prime editing therapy for AATD is in preclinical testing and could produce initial human data next year, while Beam's base editing treatment is in advanced clinical development. - Beam stated it "respectfully disagrees" with aspects of the ruling but acknowledged the decision does not affect its broader exclusive rights to certain prime editing tools.
- Saol Therapeutics has resubmitted its NDA for SL1009 (sodium dichloroacetate) to the FDA for treating pyruvate dehydrogenase complex deficiency, a rare mitochondrial disease with no approved therapies. - The resubmission follows a Complete Response Letter in August 2025 and incorporates additional survival analyses requested by the FDA, without requiring a new clinical trial. - SL1009 has received Priority Review, Orphan Drug Designation, and Rare Pediatric Disease Designation, with Saol anticipating a Priority Review Voucher upon approval. - If approved, SL1009 would become the first FDA-approved pharmacological treatment for PDCD, which is currently managed only with ketogenic diets and supportive care.
- Saol Therapeutics has been granted a Type A meeting with the FDA on December 18th to discuss new data for SL1009, a sodium dichloroacetate oral solution for treating Pyruvate Dehydrogenase Complex Deficiency (PDCD). - The company aims to secure approval without conducting an additional clinical trial, presenting expanded analyses including functional benefit, survival benefit, mechanistic support, and safety data from over 100 patient-years of exposure. - PDCD is a rare and life-threatening genetic disorder causing chronic energy deficit, lactic acidosis, and developmental problems, with no currently approved FDA therapies available. - SL1009 has received Priority Review, Orphan Drug Designation, and Rare Pediatric Disease Designation from the FDA, highlighting its potential significance for this ultra-rare condition.
- The FDA issued a Complete Response Letter for Saol Therapeutics' SL1009 (sodium dichloroacetate) New Drug Application, requiring additional deficiencies to be addressed before approval for treating Pyruvate Dehydrogenase Complex Deficiency. - PDCD affects fewer than 1,000 individuals in the U.S. with an estimated incidence of 1 in 40,000 live births, and currently has no FDA-approved treatments available. - Saol maintains that four years of clinical data from two phase III studies support SL1009's potential as an important treatment option, and the company seeks regulatory flexibility to avoid additional lengthy trials. - Patient access to SL1009 continues through ongoing clinical trials and expanded access programs while the company works with the FDA on a path forward.
- The FDA has accepted Saol Therapeutics' NDA for SL1009 (sodium dichloroacetate) with Priority Review for treating Pyruvate Dehydrogenase Complex Deficiency (PDCD). - SL1009, an oral solution, targets PDK to enhance ATP production in PDCD patients and has Orphan Drug, Fast Track, and Rare Pediatric Disease Designations. - The NDA is supported by Phase 3 (SL1009-01) and survival (SL1009-02) studies, showing mechanistic characterization and clinical benefits of DCA in PDCD patients. - If approved, SL1009 would be the first FDA-approved therapy for PDCD, addressing a critical unmet need for children with this life-threatening condition.
