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,

CURX

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

Curanex Advances Drug Development with Key Milestones and Funding

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 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,
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 <h3>AI Summary</h3>
 Curanex Pharmaceuticals announced significant operational progress as they prepare for an IND submission for Phyto-N targeting ulcerative colitis in Q4 2026. The company&#039;s advancements in manufacturing, toxicology, and intellectual property strengthen its market position amidst securing funding for continued development.
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 <h3>Key Points</h3>
 <ul><li>Curanex aims for IND submission by Q4 2026 for Phyto-N.</li><li>Completed GMP pilot batch for IND-enabling toxicology studies.</li><li>Patent filing strengthens IP position for diverse diseases.</li><li>Continues evaluating broader pipeline beyond ulcerative colitis.</li><li>Funding secured to support development through at least Q1 2027.</li></ul>
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 <h3>Companies Mentioned</h3>
 <ul><li>Curanex Pharmaceuticals Inc. (CURX): Focused on advancing therapeutic assets with upcoming IND submissions.</li></ul>
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 <h3>Corporate Developments</h3>
 This falls under &#039;Corporate Developments&#039; as it highlights Curanex&#039;s strategic progress and preparedness for regulatory approval processes, key for attracting future investment.
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 <h3>Market-Moving</h3>
 <ul><li>Successful IND submission could significantly boost CURX&#039;s stock price.</li><li>Advancements in toxicology studies indicate strong drug potential.</li><li>Strong market for ulcerative colitis treatments may drive investor interest.</li><li>Funding clarity supports uninterrupted development, enhancing investor confidence.</li></ul>
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 <h3>Key Facts</h3>
 <ul><li>Curanex&#039;s IND submission for Phyto-N is targeted for Q4 2026.</li><li>Ulcerative colitis market expected to grow from $8.17 billion (2023) to $11.39 billion (2030).</li><li>GMP pilot batch of Phyto-N completed in February 2026.</li><li>Patent filed in March 2025 covers a range of therapeutic applications.</li><li>Funding secured for at least the next twelve months post-IPO.</li></ul>
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 <h3>Trading Thesis</h3>
 Investors should consider a long position in CURX ahead of the IND submission in Q4 2026.
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<link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css"></link>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:<a class="ticker" href="https://www.benzinga.com/quote/CURX">CURX</a>) ("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: <a href="https://www.globenewswire.com/Tracker?data=j5RtC0fwl6CrvLkuv1k1xThzKKwY9zMDAVobFXaQsBUz7AXKQnH94QJ1sG3EK28cDDVb8AZaPP3zGyKN5DwXcVYzivspy-vFdA33boi4tjk=" rel="nofollow" target="_blank">ir@curanexpharma.com</a> <img alt="" class="__GNW8366DE3E__IMG" src="https://www.globenewswire.com/newsroom/ti?nf=OTY4MTE1NiM3NTExNDI4IzUwMDE1MTAwNQ=="></img> <img alt="" src="https://ml.globenewswire.com/media/ZGRlMDhjYTItYjE4Yi00YTU5LTljN2QtYWI4ZTIyZjEzODczLTUwMDE1MTAwNS0yMDI2LTAzLTMwLWVu/tiny/Curanex-Pharmaceuticals-Inc.png" referrerpolicy="no-referrer-when-downgrade"></img><a href="https://www.globenewswire.com/NewsRoom/AttachmentNg/29bc3de5-6a82-4a17-a165-6a79eef16d74"><img src="https://ml.globenewswire.com/media/29bc3de5-6a82-4a17-a165-6a79eef16d74/small/logo-png.png" border="0" width="99" height="79" alt="Primary Logo"></img></a>

Curanex Pharmaceuticals announced significant operational progress as they prepare for an IND submission for Phyto-N targeting ulcerative colitis in Q4 2026. The company's advancements in manufacturing, toxicology, and intellectual property strengthen its market position amidst securing funding for continued development.

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

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