Relief Therapeutics Announces Positive Results from Pivotal Bioequivalence Study of RLF-OD032

Core Viewpoint - Relief Therapeutics announced positive results from a pivotal bioequivalence clinical study for RLF-OD032, demonstrating it is bioequivalent to KUVAN® Powder, supporting a planned NDA submission in early 2026 [1] Company Summary - Relief Therapeutics is a biopharmaceutical company focused on innovative treatment options for specialty, unmet, and rare diseases [1] - The study evaluated RLF-OD032, a highly concentrated liquid formulation of sapropterin dihydrochloride, aimed at treating phenylketonuria (PKU) [1] Study Results - The pivotal study achieved its primary pharmacokinetic endpoints, confirming the bioequivalence of RLF-OD032 to KUVAN® Powder as defined by the U.S. Food and Drug Administration [1]