Hyloris Pharmaceuticals SA is a specialty biopharmaceutical company dedicated to addressing unmet medical needs by innovating, reformulating, and repurposing existing medications. The company leverages established regulatory pathways, such as the FDA’s 505(b)(2) in the U.S. and equivalents elsewhere, to optimize development timelines, reduce costs, and minimize risks for pharmaceuticals with proven safety and efficacy profiles. Hyloris has developed a broad proprietary portfolio of 19 value-added medicines as of late 2024, spanning reformulated and repurposed products alongside high-barrier generics. Key commercial-stage assets include Sotalol IV, an intravenous treatment for atrial fibrillation partnered in the U.S., and Maxigesic® IV, a non-opioid analgesic for post-operative pain available in over 20 countries. Recent additions like HY-083 for idiopathic rhinitis and HY-088 for hypophosphatemia target underserved conditions such as nasal symptoms and mineral deficiencies. Headquartered in Liège, Belgium, and founded in 2012, Hyloris employs around 37 multinational professionals and aims to lead in 505(b)(2)-eligible products, delivering improvements for patients, healthcare providers, and payers through technological expertise and strategic partnerships.