CURX

Completed GMP manufacturing and toxicology milestones supporting planned Q4 2026 IND submission for ulcerative colitis Expanded pipeline strategy to include cancer cachexia, a serious cancer-associated wasting condition with no FDA-approved therapies specifically indicated for the condition Jericho, New York, May 14, 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 first quarter 2026 business update highlighting continued progress with Phyto-N, the Company’s lead drug candidate. Curanex is advancing Phyto-N toward a planned Investigational New Drug (“IND”) submission to the U.S. Food and Drug Administration (“FDA”) for ulcerative colitis in the fourth quarter of 2026. During the first quarter, the Company completed two important development milestones: production of a Good Manufacturing Practice (“GMP”)-compliant pilot-scale batch of Phyto-N and completion of a dose-range finding toxicology study in rats and dogs. “Curanex made meaningful progress during the first quarter as we continued advancing Phyto-N toward a planned FDA submission,” said Jun Liu, Chief Executive Officer of Curanex. “We completed key manufacturing and toxicology milestones, continued building the development package for our lead ulcerative colitis program, and expanded our pipeline strategy to include cancer cachexia, a serious condition with significant unmet medical need. Looking ahead, we are focused on completing the IND-enabling work required to support our planned submission and moving Phyto-N toward clinical development.” First Quarter and Recent Highlights Advanced Phyto-N toward planned Q4 2026 IND submission Curanex continues to advance Phyto-N as its lead development candidate, with ulcerative colitis as the Company’s initial target indication. The Company is preparing Phyto-N for a planned IND submission in the fourth quarter of 2026. If the IND is allowed to proceed by the FDA, Curanex expects to initiate a Phase I clinical trial following the applicable FDA review period. Completed GMP pilot-scale manufacturing In February 2026, Curanex completed a pilot-scale batch of Phyto-N manufactured under GMP standards. The GMP-compliant pilot material is intended to support Good Lab...