Curanex Shares Jump 56% After GMP Batch Completion for Phyto-N
Curanex Pharmaceuticals’ shares surged 56.32% after-hours to $0.49 following completion of a GMP-compliant pilot-scale batch of its lead botanical candidate, Phyto-N. The GMP batch will enable GLP toxicology and pharmacokinetic studies ahead of an IND submission for ulcerative colitis planned in Q4 2026.
1. Pilot-Scale GMP Batch Completion
Curanex completed a GMP-compliant pilot-scale batch of its lead botanical drug candidate, Phyto-N, representing a pivotal manufacturing milestone. This batch is designed to meet regulatory standards and will underpin upcoming safety and pharmacokinetic evaluations.
2. Advancement of IND Preparation
The GMP batch output will support GLP-compliant toxicology and pharmacokinetic studies, following non-GLP toxicity tests in rats and dogs that showed no treatment-related adverse effects. These studies set the stage for an Investigational New Drug submission targeting ulcerative colitis in Q4 2026.
3. After-Hours Stock Surge
Shares of Curanex rose 56.32% in after-hours trading to $0.49, recovering from a 52-week low of $0.27 and reflecting renewed investor interest. The company’s market capitalization stands at $8.73 million, with the stock poised near the bottom of its annual range.