Curanex Provides Business Update in Connection with 2025 Annual Report as Phyto-N Advances Toward Planned IND Submission

Rhea-AI Summary

Curanex (Nasdaq: CURX) provided a business update alongside its 2025 Form 10-K, reporting operational progress toward a planned IND submission for Phyto-N in Q4 2026. The company completed a pilot-scale GMP batch, finished dose-range finding toxicology in rats and dogs, filed a PCT application in March 2025, and says it has funding for at least twelve months to support near-term IND-enabling activities.

Positive

• Pilot-scale GMP batch of Phyto-N completed (Feb 2026)
• Dose-range finding toxicology found no treatment-related adverse findings of significance
• PCT patent application filed March 2025 covering multi-indication claims
• Plans to submit IND for ulcerative colitis in Q4 2026
• Management reports funding for at least 12 months of operations

Negative

• IND submission and Phase 1 start are subject to completion of studies and regulatory review
• Funding described only for at least 12 months, implying future capital needs beyond that period

Key Figures

Planned IND timing: Q4 2026 Planned Phase 1 start: Q4 2026 Ulcerative colitis market 2023: $8.17 billion +5 more

8 metrics

Planned IND timing Q4 2026 Targeted IND submission for ulcerative colitis

Planned Phase 1 start Q4 2026 Planned Phase 1 clinical development in Australia

Ulcerative colitis market 2023 $8.17 billion Ulcerative-colitis segment of IBD treatment market in 2023

Ulcerative colitis market 2030 $11.39 billion Projected value of ulcerative-colitis segment by 2030

Market year baseline 2023 Base year for ulcerative-colitis market size estimate

Market projection year 2030 Projection year for ulcerative-colitis market size

Funding runway 12 months Management expects funding to cover at least next twelve months

Lead asset indication count 6 indications Disclosed pipeline: UC, atopic dermatitis, COVID-19, diabetes, NAFLD, gout

Market Reality Check

Price: $0.4880 Vol: Volume 101,623 is below t...

low vol

$0.4880 Last Close

Volume Volume 101,623 is below the 20-day average of 377,625, indicating muted pre-news trading interest. low

Technical Shares trade below the 200-day MA of 1.15, reflecting a longer-term downtrend despite recent updates.

Peers on Argus

Peer moves are mixed: HUMA down 17.79%, PRQR down 10.12%, OABI up 1.96%. Momentu...

2 Up 1 Down

Peer moves are mixed: HUMA down 17.79%, PRQR down 10.12%, OABI up 1.96%. Momentum scanner shows HUMA down 2.52%, PRQR up 1.99%, SGMT up 2.46%, suggesting stock-specific rather than broad sector action for CURX.

Historical Context

5 past events · Latest: Mar 18 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 18	Preclinical milestone	Positive	+10.4%	Favorable maximum-dose toxicology results for Phyto-N supporting pivotal GLP toxicology.
Mar 12	Advisory board update	Positive	-11.6%	Addition of two researchers to Scientific Advisory Board to support IND planning.
Mar 11	Advisory board expansion	Positive	+6.2%	Appointment of two veteran industry leaders to advise on portfolio and strategy.
Mar 05	Advisory board formation	Positive	-5.0%	Formation of five-member Scientific Advisory Board supporting R&D and commercialization.
Feb 25	CMC / regulatory update	Positive	+4.3%	Completion of GMP pilot batch and confirmation of Q4 2026 IND target for ulcerative colitis.

Pattern Detected

Recent news often triggers sizable but mixed reactions, with 3 aligned and 2 divergent moves vs. news tone.

Recent Company History

Over the past months, Curanex issued several updates around Phyto-N and corporate build-out. On Feb 25, 2026, a GMP pilot batch and IND-enabling readiness update saw a 4.26% gain. A toxicology milestone on Mar 18, 2026 coincided with a 10.43% rise. Multiple Scientific Advisory Board announcements between Mar 5–12, 2026 produced both positive and negative reactions, underscoring that management and governance news has elicited inconsistent price responses even when operational messages are constructive.

Market Pulse Summary

This announcement details continued IND-enabling progress for Phyto-N, with a targeted IND submissio...

Analysis

This announcement details continued IND-enabling progress for Phyto-N, with a targeted IND submission and Phase 1 start in Q4 2026, as well as pipeline optionality across six indications. The cited ulcerative-colitis market, projected to grow from $8.17 billion in 2023 to $11.39 billion by 2030, underscores the commercial scope. Investors may watch execution on GLP toxicology, regulatory interactions, funding beyond the next 12 months, and any updates to address the prior Nasdaq bid-price notice.

Key Terms

investigational new drug, ulcerative colitis, chemistry, manufacturing and controls, cmc, +2 more

6 terms

investigational new drug regulatory

"toward a planned Investigational New Drug (“IND”) submission for ulcerative colitis"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

ulcerative colitis medical

"IND submission for ulcerative colitis in the fourth quarter of 2026"

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.

chemistry, manufacturing and controls technical

"advanced key chemistry, manufacturing and controls (“CMC”) activities for Phyto-N"

Chemistry, manufacturing and controls (CMC) is the package of technical information that explains how a drug or biologic is made, tested and kept consistent, submitted to regulators to demonstrate the product’s safety, purity and reliable production. Investors care because robust CMC lowers the risk of manufacturing delays, regulatory rejection or costly recalls — think of it as the product’s recipe and kitchen controls that determine whether a medicine can be scaled, sold and generate revenue.

cmc technical

"advanced key chemistry, manufacturing and controls (“CMC”) activities for Phyto-N"

Chemistry, Manufacturing, and Controls (CMC) describes the technical documentation and processes that show how a drug or medical product is made, tested for consistent quality, and kept stable from batch to batch. Investors care because strong CMC means a product can be manufactured reliably at scale and meet regulatory standards—similar to proving a recipe can be cooked the same way in any kitchen before restaurants expand—affecting approval, production costs, and potential revenue.

gmp technical

"scale-up to GMP-compliant pilot material"

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.

pharmacokinetic medical

"intended to support GLP toxicology, pharmacokinetic and related IND-enabling 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.

AI-generated analysis. Not financial advice.

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

FAQ

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

Curanex plans to submit an IND for Phyto-N in Q4 2026. According to the company, this timing is subject to completion of required IND-enabling studies and regulatory review before submission.

What manufacturing progress has Curanex (CURX) reported for Phyto-N as of March 30, 2026?

Curanex completed a pilot-scale GMP batch of Phyto-N in February 2026. According to the company, this batch is intended to support GLP toxicology, PK and IND-enabling studies.

What did the dose-range finding toxicology studies for Phyto-N report for Curanex (CURX)?

Dose-range finding studies in rats and dogs identified maximum feasible dose and reported no treatment-related adverse findings of significance. According to the company, results inform design of the pivotal GLP toxicology program.

Does Curanex (CURX) have patent protection plans for Phyto-N and related assets?

Curanex filed a PCT application in March 2025 covering compositions and methods across multiple disease areas. According to the company, this expands its intellectual property around core therapeutic assets.

How long does Curanex (CURX) say its current funding will support operations?

Management states it has funding to support operations and capital needs for at least the next twelve months. According to the company, this follows completion of its IPO and supports near-term IND activities.