Curanex Completes Pilot-Scale GMP Batch, Eyes Q4 2026 IND Submission
Curanex advanced key CMC activities for Phyto-N, completing a pilot-scale GMP batch in February 2026 and dose-range toxicology studies with no significant adverse findings. The company plans an IND submission for ulcerative colitis in Q4 2026, is expanding to atopic dermatitis and COVID-19 indications, and secures twelve months' funding.
1. Operational Progress
Curanex advanced key chemistry, manufacturing and controls activities for Phyto-N during 2025 and early 2026, culminating in a pilot-scale GMP batch completed in February 2026 to support GLP toxicology, pharmacokinetic and IND-enabling studies.
2. Nonclinical Milestones
The company completed dose-range finding toxicology studies in rats and dogs, identifying the maximum feasible dose with no treatment-related adverse findings, which informs the design of its pivotal GLP toxicology program.
3. Regulatory Pathway & Market Outlook
Curanex maintains its regulatory pathway targeting an IND submission for ulcerative colitis in Q4 2026 and Phase 1 clinical initiation in Australia, while the ulcerative-colitis segment is projected to grow from $8.17 billion in 2023 to $11.39 billion by 2030.
4. Pipeline Expansion & Funding
The company filed a PCT application covering autoimmune, metabolic and viral indications, continues evaluating atopic dermatitis and COVID-19 opportunities beyond its lead program, and secures funding for at least twelve months following its IPO.