Curanex Provides Operational Update on Key Regulatory Milestones

Rhea-AI Summary

Curanex (Nasdaq: CURX) completed a GMP-compliant pilot-scale batch of its lead botanical candidate Phyto-N, advancing CMC readiness to support GLP toxicology, pharmacokinetic, and other IND-enabling studies. The company continues to target an IND submission for ulcerative colitis in Q4 2026.

Completed CMC activities include QC methods for raw materials, lab-scale process optimization, and GMP pilot production; non-GLP safety and metabolism studies showed no treatment-related toxicity and minimal interspecies variability.

Positive

• Completed GMP pilot-scale batch of Phyto-N
• Targets IND submission in Q4 2026
• Developed QC methods for botanical raw materials
• Non-GLP acute toxicity studies showed no treatment-related toxicity

Negative

• IND submission is still targeted, not submitted
• GLP toxicology and PK studies are pending initiation

Key Figures

IND target: Q4 2026 UC patient population: 5 million patients

2 metrics

IND target Q4 2026 Planned IND submission timing for ulcerative colitis

UC patient population 5 million patients Estimated global ulcerative colitis prevalence cited for market need

Market Reality Check

Price: $0.3026 Vol: Volume 46,367 is at 0.24x...

low vol

$0.3026 Last Close

Volume Volume 46,367 is at 0.24x the 20-day average, indicating muted trading interest into this update. low

Technical Shares at 0.3026 are trading below the 200-day MA of 1.28, reflecting a sustained downtrend since the IPO.

Peers on Argus

While CURX slipped 1.14%, peers were mixed: HUMA down 0.88%, OABI up 0.58%, PRQR...

While CURX slipped 1.14%, peers were mixed: HUMA down 0.88%, OABI up 0.58%, PRQR up 4.86%, and SLN up 5.96%, pointing to a stock-specific reaction rather than a coordinated biotech move.

Historical Context

3 past events · Latest: Oct 22 (Positive)

Pattern 3 events

Date	Event	Sentiment	Move	Catalyst
Oct 22	IR engagement	Positive	+14.4%	Hired IR firm to boost communications and highlight pipeline strategy.
Sep 12	Over-allotment exercised	Positive	+5.0%	Underwriters exercised IPO over-allotment adding $2.25M in gross proceeds.
Aug 27	IPO closing	Positive	+11.4%	Completed Nasdaq IPO raising $15M to fund development programs.

Pattern Detected

Past corporate and financing updates have generally seen positive price reactions, suggesting investors previously rewarded capital raises and visibility efforts.

Recent Company History

Since its Nasdaq IPO in August 2025, Curanex has focused on capital formation and investor communication while advancing its botanical pipeline. The IPO closing and subsequent over-allotment exercise raised a combined $17.25M and were followed by double‑digit percentage gains. An October 2025 investor relations engagement also coincided with a strong positive move. Today’s GMP and IND‑preparation update continues the theme of steady operational progress toward a planned 2026 IND for ulcerative colitis.

Market Pulse Summary

This announcement highlights Curanex’s completion of a GMP-compliant pilot batch for Phyto-N and con...

Analysis

This announcement highlights Curanex’s completion of a GMP-compliant pilot batch for Phyto-N and continued preparation for an ulcerative colitis IND targeted for Q4 2026. It reinforces a stepwise, regulatory-aligned approach, building on earlier IPO and investor relations milestones. Investors may track progress into GLP toxicology, pharmacokinetic studies, and eventual IND filing, alongside the company’s ability to maintain its listing and fund preclinical and future clinical development.

Key Terms

good manufacturing practice (gmp), gmp, investigational new drug (ind), chemistry, manufacturing and controls (cmc), +4 more

8 terms

good manufacturing practice (gmp) regulatory

"announced the completion of a Good Manufacturing Practice (GMP)-compliant pilot-scale batch"

Good Manufacturing Practice (GMP) is a set of government-enforced standards that ensure medicines, medical devices, and related products are produced consistently, safely, and with the quality claimed on the label. Think of it as a strict recipe and hygiene checklist for a factory that prevents contamination, errors, and product variations. Investors care because GMP compliance affects a company’s ability to sell products, avoid costly recalls or regulatory shutdowns, and maintain reliable revenue and reputation.

gmp regulatory

"GMP-compliant pilot-scale batch of its lead botanical drug candidate, Phyto-N"

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.

investigational new drug (ind) regulatory

"preparation for its planned Investigational New Drug (IND) submission for ulcerative colitis"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

chemistry, manufacturing and controls (cmc) regulatory

"focusing on preclinical development and Chemistry, Manufacturing and Controls (CMC) readiness"

Chemistry, manufacturing and controls (CMC) is the set of scientific and operational steps that show how a drug or biologic is made, what goes into it, and how its quality is consistently checked—think of it as the recipe, the factory process, and the quality checklist for a medicine. Investors care because strong CMC reduces risks around regulatory approval, production delays, batch failures and unexpected costs, directly affecting a product’s ability to reach market and generate revenue.

good laboratory practice (glp) regulatory

"support GLP-compliant toxicology, pharmacokinetic, and other IND-enabling nonclinical studies"

Good Laboratory Practice (GLP) is a set of rules and record-keeping standards that ensure nonclinical laboratory studies—such as safety and toxicity tests—are done consistently, documented fully, and traceable. For investors, GLP compliance signals that preclinical data are reliable and less likely to be rejected by regulators, reducing development and regulatory risk much like a detailed recipe and audit trail make a complex dish repeatable and verifiable.

pharmacokinetic medical

"GLP-compliant toxicology, pharmacokinetic, and other IND-enabling nonclinical studies"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

toxicology medical

"Safety: Non-GLP acute toxicity studies in rats and dogs did not identify"

Toxicology is the science that studies how chemicals, drugs or other substances can harm people, animals or the environment and determines what exposure levels are safe. For investors, toxicology results act like a safety checklist: they influence whether a product can get regulatory approval, be sold without restrictions, or face recalls and legal risks—factors that can materially affect a company’s prospects and stock value.

ulcerative colitis medical

"Phyto-N is Curanex’s lead preclinical botanical drug candidate under development for inflammatory diseases, with ulcerative colitis as the initial target"

A long-term inflammatory disease that causes repeated sores and irritation in the large intestine, leading to symptoms such as abdominal pain, urgent diarrhea, and fatigue. For investors, it matters because the condition creates a steady need for effective treatments, influences the size of drug and medical-device markets, and makes clinical trial results, regulatory decisions and treatment approvals material to companies’ revenue prospects—like watching for fixes to a recurring leak in an important building system.

AI-generated analysis. Not financial advice.

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

info@curanexpharma.com.

FAQ

What manufacturing milestone did Curanex (CURX) announce on February 25, 2026?

Curanex completed a GMP-compliant pilot-scale batch of Phyto-N to support IND-enabling studies. According to the company, this material will support GLP toxicology, pharmacokinetic, and other nonclinical studies needed for IND preparation.

When does Curanex (CURX) plan to submit the IND for Phyto-N for ulcerative colitis?

Curanex is targeting an IND submission in Q4 2026 for ulcerative colitis. According to the company, remaining steps include initiation and completion of GLP toxicology and pharmacokinetic studies before filing.

What preclinical safety results did Curanex (CURX) report for Phyto-N in February 2026?

Non-GLP acute toxicity studies in rats and dogs reported no treatment-related toxicological findings. According to the company, these exploratory studies used laboratory-scale material and support continued nonclinical development.

How will the GMP pilot material from Curanex (CURX) be used in IND-enabling studies?

The GMP pilot material will support GLP toxicology and pharmacokinetic studies and other IND-enabling nonclinical work. According to the company, this improves manufacturing reproducibility and strengthens CMC documentation for the IND.

Did Curanex (CURX) complete CMC activities for Phyto-N ahead of the IND filing?

Curanex completed several CMC activities, including QC method development and lab-scale process optimization. According to the company, scale-up and production of GMP-compliant pilot material are now finished to support IND preparation.

What are the next development steps for Phyto-N after Curanex's February 2026 update?

Next steps include initiating formal GLP toxicology and PK studies and preparing IND documentation for FDA submission. According to the company, subsequent clinical development is planned subject to regulatory approvals.