Niagen Bioscience, Inc. (NASDAQ: NAGE) has appointed Abhijit Kale, Ph.D., as Senior Director of Global External Research, effective July 20, 2026. Dr. Kale will lead the company's Global Niagen Research Program, overseeing its worldwide network of academic and clinical research collaborations and shaping its scientific research strategy. This appointment aims to deepen the company's engagement with leading investigators to advance discoveries in NAD+ biology and age-related health.

Leadership and Strategy

"Science informs our strategy and our messaging, not the other way around," said Rob Fried, CEO of Niagen Bioscience. The company emphasized that Dr. Kale's role will involve working closely with investigators to strengthen Niagen Bioscience's position as a scientific authority in NAD+ research. Dr. Kale brings over a decade of experience in aging biology, translational science, and external scientific partnerships.

Professional Background

Dr. Kale most recently served as a Scientific Review Officer at Hevolution Foundation, where he evaluated more than 600 research proposals and contributed to funding recommendations across a $1 billion global longevity research portfolio. His previous roles include scientific leadership positions at the Buck Institute for Research on Aging, Deciduous Therapeutics, and LevitasBio. He earned his Ph.D. in Molecular Genetics from Albert Einstein College of Medicine and has authored 16 publications, including foundational research on NAD+ biology and aging.

Niagen Research Program

The Global Niagen Research Program is a scientific collaboration initiative in the healthspan field. Independent investigators from institutions such as Mayo Clinic, National Institutes of Health (NIH), Harvard University, MIT, and Cambridge University participate in the program. It provides oral food-grade and pharmaceutical-grade Niagen material, scientific collaboration, and technical support.

Research Focus and Expansion

Research under the program spans healthy aging, metabolism, mitochondrial function, cognitive and cardiovascular health, inflammation, and rare diseases. The program has also expanded into indications such as Peripheral Artery Disease and Ataxia Telangiectasia. Under Dr. Kale's leadership, Niagen Bioscience plans to expand the program to support emerging areas of NAD+ science, including pharmaceutical-grade Niagen injections and infusions, topical applications, and research on other NAD+ precursors.

Niagen Bioscience, Inc. (NASDAQ: NAGE) announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease (RPD) Designation for its proprietary lead small molecule drug candidate NB4168 for the treatment of Ataxia Telangiectasia (A-T). Additionally, the European Medicines Agency (EMA) granted Orphan Medicinal Product Designation (OMPD) to NB4168 for the treatment of A-T. These regulatory designations recognize the significant unmet medical need in A-T and provide development incentives intended to support and accelerate the advancement of promising therapies for rare diseases.

The FDA granted RPD Designation based on its determination that A-T is a serious and life-threatening disease that primarily affects individuals from birth through adolescence and meets the statutory definition of a rare disease. The EMA's Committee for Orphan Medicinal Products similarly concluded that NB4168 met the criteria for orphan designation for the treatment of A-T. Together, these designations provide regulatory recognition in the European Union and further support the company's plans to advance the program globally.

NB4168 is an oral small molecule therapy engineered to deliver substantially greater nicotinamide riboside (NR) exposure than conventional NR while maintaining a differentiated pharmacokinetic and safety profile. It is designed to have significantly higher bioavailability and increase NAD+, a coenzyme essential for DNA repair, mitochondrial function, cellular energy production, and stress responses—biological pathways disrupted in A-T. As A-T is categorized as a rare genetic premature aging disease, NB4168 may translate to other age-related diseases.

Rob Fried, Chief Executive Officer of Niagen Bioscience, stated that receiving RPD Designation from the U.S. FDA and OMPD from the EMA represents meaningful regulatory validation of NB4168 and the company's strategy to develop therapies for patients with serious rare diseases. He noted that these milestones strengthen the path toward clinical development and reinforce the opportunity to extend the company's leadership in NAD+ science into regulated medicines.

About Ataxia Telangiectasia (A-T)

A-T is a rare genetic disease caused by mutations in the ATM gene. The disease typically presents in early childhood and is characterized by progressive loss of motor coordination, impaired immune function, increased susceptibility to infections, pulmonary complications, a substantially elevated risk of cancer, and premature aging. There are currently no FDA-approved therapies for A-T, and treatment is largely limited to supportive care. A-T impacts roughly 1 in 40,000 people in the U.S. and 1 in 150,000 people in Europe.

Regulatory Designations and Development

The FDA's RPD Designation is intended to encourage the development of therapies for serious and life-threatening diseases that primarily affect children. The EMA's OMPD is granted to therapies intended to diagnose, prevent, or treat life-threatening or chronically debilitating rare diseases affecting fewer than five in 10,000 people in the European Union. Niagen Bioscience is currently advancing preclinical development activities and plans to submit an Investigational New Drug (IND) application to the FDA in anticipation of initiating human clinical studies.

Key Details of the NB4168 Program