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Curanex Provides Operational Update on Key Regulatory Milestones
Company Completes GMP Pilot for Phyto-N, Targets Ulcerative Colitis IND Submission Q4 2026 Jericho, New York, Feb. 25, 2026 (GLOBE NEWSWIRE) -- Curanex
About this update from Curanex Pharmaceuticals Inc
[{"type":"text","content":"Company Completes GMP Pilot for Phyto-N, Targets Ulcerative Colitis IND Submission Q4 2026 Jericho, New York, Feb. 25, 2026 (GLOBE NEWSWIRE) -- Curanex Pharmaceuticals Inc. (Nasdaq: CURX) (“Curanex” or the “Company”), a development-stage pharmaceutical company focused on the discovery and development of botanical drugs for the treatment of inflammatory diseases, today announced the completion of a Good Manufacturing Practice (GMP)-compliant pilot-scale batch of its lead botanical drug candidate, Phyto-N. This pilot marks a key manufacturing milestone in preparation for its planned Investigational New Drug (IND) submission for ulcerative colitis. Since completing its initial public offering in August 2025, Curanex has steadily advanced its lead program in strict alignment with U.S. Food and Drug Administration (FDA) regulatory requirements, focusing on preclinical development and Chemistry, Manufacturing and Controls (CMC) readiness. The Company continues to target submission of its first IND application for ulcerative colitis in the fourth quarter of 2026. GMP Pilot-Scale Manufacturing Milestone The Company has successfully completed a pilot-scale batch of Phyto-N manufactured under GMP standards. This GMP-compliant material is intended to support GLP-compliant toxicology, pharmacokinetic, and other IND-enabling nonclinical studies. Completion of the GMP pilot-scale batch represents an important step in strengthening the Company’s manufacturing foundation, as it advances toward IND submission. Key CMC activities completed to date include: Development of quality control methods for botanical raw materials and extracted drug substance;Laboratory-scale process optimization, including extraction, concentration, and drying; andScale-up and production of GMP-compliant pilot material With GMP pilot-scale material now available, the Company is actively working on initiation formal GLP toxicology and pharmacokinetic studies as part of its IND preparation. Curanex’s Chief Executive Officer, Mr. Jun Liu, commented, “Completion of a GMP-compliant pilot-scale batch marks a key milestone in the advancement of our Phyto-N program. High-quality and reproducible preclinical data, supported by robust manufacturing standards, are an essential factor for successful regulatory submissions. This has been a successful, critical next step as we prepare...