Curanex Pharmaceuticals announced that it has finished a Good Manufacturing Practice (GMP)–compliant pilot‑scale batch of its lead botanical drug candidate, Phyto‑N, the company’s primary asset for ulcerative colitis. The completion of the GMP pilot provides the high‑quality material needed to support the company’s upcoming GLP toxicology, pharmacokinetic, and other IND‑enabling studies.
The GMP material will be used to generate the preclinical data required for an Investigational New Drug (IND) submission scheduled for the fourth quarter of 2026. CEO Jun Liu said, "Completion of a GMP‑compliant pilot‑scale batch marks a key milestone in the advancement of our Phyto‑N program. High‑quality and reproducible preclinical data, supported by robust manufacturing standards, are an essential factor for successful regulatory submissions. This has been a successful, critical next step as we prepare our first IND submission for FDA review."
Dr. Liqin Xie, COO, added, "With the data from the GMP material now available, we are positioned to advance our GLP toxicology and pharmacokinetic studies as we work toward our targeted IND submission in the fourth quarter of 2026. Subject to regulatory approvals, we intend to pursue subsequent clinical development, including in Australia."
The milestone moves Curanex from preclinical development toward the first human trials, a key inflection point that could unlock future partnership or funding opportunities. It also strengthens the company’s regulatory foundation and may improve investor confidence in its ability to execute its botanical platform. The company’s Nasdaq delisting warning, with a deadline of May 4, 2026, adds urgency to the need for positive development milestones and potential capital raises.
Curanex completed its initial public offering in August 2025, raising $15 million plus an over‑allotment option of $2.25 million for a total of $17.25 million. The company is pre‑revenue and has a market capitalization of approximately $8.5–$8.8 million as of late February 2026. It holds more cash than debt and a strong current ratio, but the Nasdaq delisting risk underscores the importance of maintaining investor confidence and securing additional funding to support the IND filing and subsequent clinical development.
Ulcerative colitis affects roughly 5 million patients worldwide, underscoring the potential market for Phyto‑N. The company’s botanical approach, rooted in traditional Chinese medicine, positions it within a growing global botanical drugs market estimated at $41 billion in 2024 and projected to expand further.
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