Business
Curanex Provides Business Update in Connection with 2025 Annual Report as Phyto-N Advances Toward Planned IND Submission
Company advances manufacturing, toxicology, patent and regulatory milestones while building a broader pharmaceutical development platform Jericho, New York,
About this update from Curanex Pharmaceuticals Inc
[{"type":"text","content":"Company advances manufacturing, toxicology, patent and regulatory milestones while building a broader pharmaceutical development platform Jericho, New York, March 30, 2026 (GLOBE NEWSWIRE) -- Curanex Pharmaceuticals, Inc. (Nasdaq: CURX) (“Curanex” or the “Company”), a pharmaceutical development company focused on advancing therapeutic assets for serious diseases with significant unmet medical need, today provided a business update in conjunction with the filing of its Annual Report on Form 10-K for the year ended December 31, 2025. The update highlights operational progress across manufacturing, nonclinical development, intellectual property and regulatory planning as the Company advances its lead asset, Phyto-N, toward a planned Investigational New Drug (“IND”) submission for ulcerative colitis in the fourth quarter of 2026. The Company is also evaluating broader therapeutic opportunities across additional indications within its pipeline. “2025 was a pivotal year for Curanex as we strengthened the operational foundation required to support a more defined pharmaceutical development strategy,” said Jun Liu, Chief Executive Officer of Curanex. “We believe we are entering the next phase of our evolution with meaningful progress in manufacturing, IND-enabling studies, intellectual property and regulatory planning, all intended to move Phyto-N toward clinical development and expand the long-term value of our therapeutic platform.” Operational Highlights Advanced manufacturing and CMC execution to support IND-enabling development During 2025 and early 2026, Curanex advanced key chemistry, manufacturing and controls (“CMC”) activities for Phyto-N, including development of quality-control methods, optimization of production processes at lab scale, and scale-up to GMP-compliant pilot material. In February 2026, the Company completed a pilot-scale GMP batch of Phyto-N intended to support GLP toxicology, pharmacokinetic and related IND-enabling studies. Management believes these activities represent an important step in transitioning Phyto-N into a more formal regulatory development path. Completed dose-range finding work supporting pivotal toxicology study design Curanex also advanced its nonclinical program through completion of a dose-range finding toxicology study in rats and dogs. The study identified the maximum feasible dose and fou...