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 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; and
• Scale-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 our first IND submission for FDA review.”

Curanex’s Chief Operating Officer, Dr. Liqin Xie added, “With the data from the GMP material now available, we are positioned to advance our GLP toxicology and pharmacokinetic studies as we work toward our targeted IND submission in the fourth quarter of 2026. Subject to regulatory approvals, we intend to pursue subsequent clinical development, including in Australia.”

Phyto-N is Curanex’s lead preclinical botanical drug candidate under development for inflammatory diseases, with ulcerative colitis as the initial target indication. Ulcerative colitis is a chronic inflammatory bowel disease affecting approximately 5 million patients globally and represents a significant unmet medical need.

We are currently focused on preclinical pharmacology, safety evaluation, and CMC activities required to support IND submission to the FDA.

Exploratory nonclinical studies the Company conducted using laboratory-scale material include:

• Safety: Non-GLP acute toxicity studies in rats and dogs did not identify treatment-related adverse toxicological findings.
• Metabolism: Hepatic microsomal metabolism studies demonstrated minimal interspecies variability, supporting continued nonclinical development.
  
  

As a part of this development strategy, Curanex will continue to advance its botanical drug development program in a stepwise, data-driven manner consistent with regulatory expectations. The Company expects to provide additional operational updates as material milestones are achieved and in accordance with applicable disclosure requirements.

About Curanex Pharmaceuticals Inc

Curanex Pharmaceuticals Inc is a developmental-stage pharmaceutical company headquartered in Jericho, New York, dedicated to discovering and developing botanical drugs for inflammatory diseases. Its lead candidate, Phyto-N, is a botanical extract from a single plant with proven anti-inflammatory properties that acts via multiple targets and mechanisms. Phyto-N has a long history of human use, having treated thousands of patients with inflammatory diseases over 30 years in China, demonstrating favorable tolerability.

The Company has validated Phyto-N's effects in animal models of six inflammatory diseases: ulcerative colitis, atopic dermatitis, COVID-19, diabetes, nonalcoholic fatty liver disease, and gout. The primary indication is moderate to severe ulcerative colitis. The Company will advance its lead botanical drug candidate, Phyto-N, through FDA-required studies, IND submission, and into Phase I clinical trials.

For more information, visit the Company’s website at www.curanexpharma.com.

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.

For more information, please contact:

Curanex Pharmaceuticals Inc

Attn: Liqin Xie, Chief Operating Officer

[email protected].