Saol Therapeutics announces FDA acceptance of New Drug Application for SL1009 for treatment of Pyruvate Dehydrogenase Complex Deficiency

ROSWELL, Ga, DUBLIN and HAMILTON, Bermuda, January 28, 2025 – Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for SL1009, Sodium Dichloroacetate Oral Solution (DCA). DCA will be used with a proprietary genetic test to treat an orphan pediatric mitochondrial disease, Pyruvate Dehydrogenase Complex Deficiency (PDCD)1. The FDA granted Priority Review for the NDA and has set a goal date of May 27, 2025, under the Prescription Drug User Fee Act (PDUFA). Priority review is designated to applications for drugs that, if approved, would provide a significant improvement in safety or effectiveness of the treatment, prevention or diagnosis of a serious medical condition. SL1009 has previously been granted Orphan Drug and Fast Track Designations. SL1009 has also been granted a Rare Pediatric Disease Designation by the FDA and thus is eligible for a Priority Review Voucher (PRV).


PDCD is a rare and life-threatening mitochondrial disorder of carbohydrate oxidation that mostly affects the nervous system and skeletal muscle and leads to decreased ATP production and energy failure. DCA is a targeted therapy that inhibits Pyruvate Dehydrogenase Kinase (PDK) to stimulate residual Pyruvate Dehydrogenase Complex (PDC) activity and increase energy (ATP) production by mitochondria.

"This NDA acceptance brings us one step closer to addressing the critical health challenges faced by these children and their families, where no approved treatment is currently available," said Dave Penake, Chief Executive Officer of Saol Therapeutics. “Reaching this regulatory milestone is both a significant scientific achievement and a deeply meaningful moment for everyone who has dedicated themselves to advancing this therapy. Further, designating our application for priority review reaffirms that the FDA views PDCD as a serious condition”


The NDA is supported by results from a Phase 3 double-blind placebo-controlled cross-over study (SL1009-01) and a survival study (SL1009-02). The totality of evidence submitted for review in the NDA includes mechanistic characterization, along with nonclinical and clinical evidence to demonstrate the safety and clinical benefit of DCA in PDCD patients.

DCA is not currently approved for any indication in the United States.

 

About Pyruvate Dehydrogenase Complex Deficiency (PDCD)

PDCD is a mitochondrial disorder of carbohydrate oxidation that mostly affects the nervous system and skeletal muscle and leads to decreased ATP production and energy failure. It is estimated that 300-500 patients are treated in expert centers in the US, and the overall prevalence is thought to be as high as 2,000. PDCD is the most common cause of congenital lactic acidosis, a life-threatening condition that may occur as early as the neonatal period. Patients suffering from PDCD may also exhibit extreme tiredness (lethargy), poor feeding, rapid breathing (tachypnea), and other signs of neurological and neuromuscular dysfunction such as developmental delay, low muscle tone (hypotonia), abnormal eye movements and seizures. Signs and symptoms usually begin soon after birth but may appear later in childhood2.

There are currently no FDA-approved therapies for PDCD.

 

About Saol Therapeutics

Saol Therapeutics (pronounced "Sail") is a privately held, clinical-stage, pharmaceutical company with operations in Roswell, GA, Dublin, Ireland and Hamilton, Bermuda. Saol is focused on development activity in CNS disorders such as spasticity and pain management, and orphan diseases. Saol is committed to providing and advancing therapeutic options for patients and the physicians treating these populations. For more information, visit www.saolrx.com.

 

Saol Therapeutics Contact
Brian Nappi, Senior Vice President, Strategy
bnappi@saolrx.com

Source: Saol Therapeutics announces FDA acceptance of New Drug Application for SL1009 for treatment of Pyruvate Dehydrogenase Complex Deficiency – Saolrx

UGA & Manus Among Awardees in $214M BioMADE Investment

April 30, 2026
BioMADE Announces $21.4 Million Invested in 14 Projects to Develop the U.S. Bioindustrial Manufacturing Industry and Advance National Security Priorities

Nutrivert announces first close on $6 million Series A-2 funding round

April 17, 2026
April 17, 2026 - Nutrivert Inc., a developer of non-antibiotic replacements for antibiotic growth promoters in livestock, today announced it has completed the first close, raising $2.375 million, of its Series A-2 funding round of $6 million. The round was led by global animal health investor Arrow Ventures with participation from other investors. The funding will be used to further develop Nutrivert’s manufacturing, human food safety and target animal safety and efficacy packages for the company’s lead product Nutrivert LDPP. Nutrivert LDPP is a proprietary, novel, orally available, lipidated synthetic enantiomeric desmuramyl analog of muramyl dipeptide, the smallest conserved immunoactive component of bacterial peptidoglycan. LDPP has no antibacterial effect but has consistently promoted growth and improved feed efficiency in pig studies. LDPP binds to the mammalian NOD2 receptor and is the only NOD2 ligand reported to inhibit the inflammatory signal NF-κB. In pilot studies, LDPP rescued 70kg pigs from an otherwise lethal dose of porcine reproductive and respiratory syndrome virus (PRRSV) and abrogated influenza disease symptoms in piglets. The Company intends to develop LDPP for all major livestock species worldwide. Patents have been granted in most major markets. The global antibiotic growth promoter market is worth an estimated $5.8 billion. Approximately 73% of all antibiotics are fed to livestock. The market is believed to be the world’s largest drug market by volume, with ~100,000 tons of active pharmaceutical ingredient administered annually. FDA’s latest data, for 2024, show a 13% rise in U.S. livestock antibiotic use since 2017. The Food and Agriculture Organization reports that livestock antibiotics are mostly given to speed animal growth. Regulators and non-governmental organizations have called for reduction of antibiotic use in livestock, citing concerns that the global, intensive use of antibiotics, often at subtherapeutic doses, selects for antimicrobial resistance: bacteria that are “immune” to antibiotics and that therefore pose a threat to public health. Spillovers of antibiotic-resistant bacteria from livestock to humans have been documented. “Nutrivert LDPP has consistently improved feed efficiency in pigs without antibiotics,” said Bernhard Kaltenboeck, CSO. “We are excited to have the support of Arrow Ventures and our other investors in bringing a new tool that will help producers reduce production costs and reduce selection pressure for antimicrobial resistance.” About Nutrivert LDPP: LDPP is an investigational compound currently undergoing clinical evaluation. It has not been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or any other global regulatory authority for any indication. The safety and efficacy of LDPP have not been established. Any mention of potential use is based on preliminary data and does not guarantee future regulatory clearance or commercial availability.

USDOL Approves National Biomanufacturing Technician Standards

April 16, 2026
[Seattle, WA] April 15, 2026 – Apprenti, the leading national intermediary for Registered Apprenticeship (RA), is proud to announce the formal approval and filing of the National Biomanufacturing Technician Standards with the U.S. Department of Labor (USDOL). Crafted under the strategic guidance of the Apprenti Life Science Advisory Board—which includes leaders from Pfizer, Merck, Thermo Fisher, and Biogen—these standards were developed in close partnership with the Life Sciences Workforce Collaborative (LSWC) and InnovATEBIO as part of a high-impact NIIMBL project. This approval represents a foundational shift for the industry, moving away from a fragmented, state-by-state approach to a scalable, consistent model for developing biomanufacturing professionals at sites across all 50 states. The national standards provide a “plug-and-play” framework that ensures a technician trained in Massachusetts or North Carolina meets the same rigorous, industry-vetted benchmarks as one in Ohio or Missouri. The foundational development of these national standards was informed by existing Life Science RA programs from organizations across the country, including: MassBioEd, Oregon Life Sciences, National Center for Therapeutics Manufacturing (NCTM), BioSTL, Wistar Institute, North Carolina Life Sciences Apprenticeship Consortium (NCLSAC) and others. A National Engine for Talent: The filing of these standards is a cornerstone of NIIMBL’s efforts to strengthen domestic biomanufacturing capabilities and develop the workforce of the future. Beyond the standards themselves, the project is delivering a suite of resources and tools—including a comprehensive Employer Toolkit and specialized screening rubrics—that state-based organizations and employers can leverage to implement RA programming for their most in-demand roles. “These national standards set the stage for a sustainable, skills-first pipeline that mirrors the rigor of the industry’s most complex manufacturing processes,” said Daniel Weagle, Director of Life Science Business Development at Apprenti. “By providing a unified approach, we are empowering national employers to scale their workforce development efforts strategically and accessibly.” The Value Proposition of Registered Apprenticeship For Life Science employers, the Registered Apprenticeship model offers a compelling business case rooted in cost-effectiveness and long-term stability: High Retention: RA programs boast exceptional retention rates—historically as high as 89% to 90%—as apprentices are trained within a company’s specific culture and protocols from day one. Cost Efficiency: Research indicates that for every dollar spent on apprenticeship, employers see an average return of $1.47 in increased productivity and reduced recruitment costs. Inclusive Innovation: The model expands access to untapped talent pools, including non-degreed individuals and career-switchers, ensuring the biomanufacturing workforce reflects the demographics of the communities it serves. As the global biopharmaceutical market is projected to exceed $570 billion by 2032 , this partnership between Apprenti, NIIMBL, and industry leaders ensures that the U.S. workforce is not just prepared for the future of manufacturing, but is actively driving it. This project was developed with an award from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and financial assistance from the U.S. Department of Commerce, National Institute of Standards and Technology (70NANB21H086). About Apprenti: Apprenti is a 501(c)(3) nonprofit organization and a U.S. Department of Labor recognized Intermediary. Apprenti designs and delivers scalable Registered Apprenticeship (RA) programs in high-demand industries. By adapting the proven apprenticeship model, Apprenti helps employers meet workforce needs while training the next generation of skilled professionals. Apprenti’s programs are industry-recognized, federally approved, and supports employers across the country. Since launching in 2015, Apprenti has partnered with employers, government agencies, and education providers to create new apprenticeship pathways. About NIIMBL The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of industry standards, and educate a world-leading workforce. Media Contact: Dan Maiese, Communications Manager, dmaiese@niimbl.org , 302-831-3824 About the Life Sciences Workforce Collaborative (LSWC) The Life Sciences Workforce Collaborative (LSWC) is a national nonprofit coalition of state, regional and national life science associations and institutes who are working together to build a competitive, and future-ready life sciences workforce. Originally founded in 2012 as the Coalition of State Bioscience Institutes (CSBI), LSWC connects industry, academia, and government partners through data-driven insights, best practice sharing, and collaborative programs. Learn more at www.LifeSciencesWorkforce.org About InnovATEBIO InnovATEBIO is a National Center for Biotechnology Education, working to advance the education of highly skilled technicians for the nation’s biotechnology workforce. Toward this goal, InnovATEBIO provides leadership in biotechnology technician education, including support for development and sharing of best practices and emerging technologies in biotechnology workforce development. Read LSWC's full announcement here.
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