Harmony Biosciences Holdings Inc

Harmony Biosciences Holdings Inc. is a pharmaceutical company whose sole commercial product, WAKIX® (pitolisant), is a treatment for narcolepsy. The drug’s development and ongoing safety monitoring relied on animal testing. Preclinical studies for pitolisant, as standard for central nervous system therapeutics, involved testing in animal models to assess efficacy and toxicity. Furthermore, as a Schedule IV controlled substance, its ongoing pharmacovigilance and any future development of new indications or formulations would likely necessitate further animal studies as part of regulatory compliance.

The company’s foundational research and continued regulatory obligations are intrinsically tied to the use of animals in biomedical research. This places Harmony Biosciences within the broad category of commercial animal exploitation for product development, as defined by the exclusion policy. There is no public commitment from the company to alternative, non-animal testing methodologies for its core research and development activities.