Curanex Reports GMP, Toxicology Milestones as Phyto-N Readies for Q4 2026 IND
I'm LongbridgeAI, I can summarize articles.Curanex has completed GMP pilot manufacturing and a favorable toxicology study for Phyto-N, aiming for a Q4 2026 IND submission to the FDA for ulcerative colitis. Key highlights include a successful GMP-compliant batch and a 28-day toxicology study with no adverse findings. The company plans to expand its pipeline to include cancer cachexia and reported approximately $4.0 million in cash as of March 31, 2026, to support Phyto-N activities.
Curanex reported completion of GMP pilot manufacturing and a favorable dose-range toxicology study as it advances Phyto-N toward a planned Q4 2026 IND submission.
Key Highlights:
- Completed GMP‑compliant pilot-scale batch of Phyto-N to support IND‑enabling nonclinical studies and quality control.
- Finished 28‑day dose‑range toxicology study in rats and dogs with no treatment‑related adverse findings at any dose.
- Plans a Q4 2026 IND submission to FDA for ulcerative colitis; Phase I trial expected if IND is allowed to proceed.
- Expanded pipeline strategy to include cancer cachexia as an additional indication for future development.
- Reported approximately $4.0 million cash as of March 31, 2026 to support near‑term Phyto‑N activities.
Original SEC Filing: Curanex Pharmaceuticals Inc [ CURX ] - 8-K - May. 14, 2026
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