SAN FRANCISCO, CA / ACCESS Newswire / June 9, 2025 / Jaguar Health, Inc. $(JAGX)$, through its subsidiary Napo Pharmaceuticals, announced a promising regulatory development following an in-person Type C Meeting with the U.S. Food and Drug Administration (FDA). The meeting focused on the statistically significant results from Napo's Phase 3 OnTarget trial targeting cancer therapy-related diarrhea $(CTD.AU)$ in adult patients with metastatic breast cancer. Jaguar Health has proposed two potential pathways to make their drug, crofelemer, available to this patient population. These include conducting a pivotal treatment trial and pursuing authorization for an expanded access program. The FDA has formally acknowledged these proposals, marking a significant step toward potential approval. Crofelemer has already been granted orphan drug designation in the US and EU for other conditions, offering development incentives and marketing exclusivity upon approval.
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