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 found no treatment-related adverse toxicological findings of significance, providing key information to support the design of the Company's pivotal GLP toxicology program. Management believes that this study represents an important milestone in preparing for the planned IND submission.
Maintains planned regulatory pathway for ulcerative colitis
Curanex continues to target submission of its first IND application for ulcerative colitis in the fourth quarter of 2026, subject to completion of required studies and regulatory review. The Company also plans to initiate Phase 1 clinical development in Australia in the fourth quarter of 2026, subject to regulatory clearance and completion of preclinical requirements. Grand View Research estimates that the ulcerative-colitis segment of the inflammatory bowel disease treatment market, valued at $8.17 billion in 2023, could be valued $11.39 billion by 2030.
Expanded intellectual property position around core therapeutic assets
In March 2025, the Company filed a Patent Cooperation Treaty ("PCT") application covering compositions, methods of use and related claims across autoimmune diseases, metabolic diseases and viral infections. Management believes this filing strengthens the long-term strategic value of the Company's development platform and core therapeutic assets.
Continued pipeline development beyond lead indication
While ulcerative colitis remains the Company's lead indication and near-term regulatory focus, Curanex continues to evaluate additional therapeutic opportunities across a broader multi-indication pipeline. The Company's disclosed pipeline includes ulcerative colitis, atopic dermatitis, COVID-19, diabetes, NAFLD and gout. Management also continues work aimed at identifying active compounds that may support future therapeutic asset development beyond the lead program.
Maintains funding position to support near-term development objectives
Following the completion of the Company's IPO, management believes it has the funding required to support operating expenses and capital requirements for at least the next twelve months, enabling the Company to continue its advancement of IND-enabling activities, regulatory preparation and additional operational milestones intended to strengthen the Company's broader therapeutic development platform.
Chief Executive Officer, Jun Liu, added, "Over the last year, we have worked to build the manufacturing readiness, nonclinical package, regulatory path and strategic flexibility required to advance Phyto-N through a disciplined development process. Our goal is to continue positioning Curanex as an emerging pharmaceutical company pursuing regulatory approvals for differentiated therapeutic assets with the potential to address major unmet medical needs."
The Company expects to provide additional updates as it advances IND-enabling activities for Phyto-N, refines its clinical development plans and evaluates broader therapeutic opportunities across its pipeline.
About Curanex Pharmaceuticals Inc.
Curanex Pharmaceuticals Inc. is a pharmaceutical development company headquartered in Jericho, New York. The Company is focused on advancing therapeutic assets for serious diseases with significant unmet medical need. Its lead asset, Phyto-N, is currently being developed for ulcerative colitis and is being advanced through preclinical and IND-enabling activities in support of a planned IND submission in the fourth quarter of 2026. The Company is also evaluating broader pipeline opportunities intended to expand its long-term therapeutic platform.
Forward-Looking Statements
All statements other than statements of historical fact in this announcement are forward-looking statements. These forward-looking statements are made as of the date hereof and involve known and unknown risks and uncertainties and are based on current expectations and projections about future events and financial trends that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Investors can identify these forward-looking statements by words or phrases such as "may," "will," "expect," "anticipate," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company's registration statement and in its other filings with the SEC.
Contact:
Curanex Pharmaceuticals Inc
Tel: (212) 671-1020 / (718) 673-6078
Email: ir@curanexpharma.com
