Jaguar Health’s Napo granted FDA Type C Meeting to discuss OnTarget study

Jaguar Health (JAGX) announced that the U.S. Food and Drug Administration has granted Napo a Type C Meeting in the second quarter of 2025 to discuss the responder analysis in the prespecified subgroup of patients with breast cancer for crofelemer in Napo’s Phase 3 OnTarget trial. Patients with breast cancer accounted for 183 of the 287 participants in this unprecedented prophylactic clinical trial recently conducted by Napo for diarrhea in adults with solid tumors receiving targeted therapy with or without standard chemotherapy. The American Cancer Society expects 316,950 new cases of breast cancer diagnosed in women in the US in 2025, and it’s estimated that there were 4 million US women with a history of invasive breast cancer in 2022. Napo recently submitted a late-breaker abstract to MASCC on additional significant results in adult breast cancer patients from the OnTarget study for consideration for presentation at MASCC’s June 26-28, 2025 Annual Meeting in Seattle, Washington. The authors include Pravin Chaturvedi, PhD, who is Jaguar’s CSO and Chair of Napo’s Scientific Advisory Board, as well as leading oncologists and cancer patient advocates. Members of Napo’s SAB are expected to join Jaguar representatives at the FDA meeting in the second quarter of 2025. As previously announced, the initial top line results from the OnTarget study showed that the multicenter, double-blind, placebo-controlled pivotal clinical trial did not meet its primary endpoint for the prespecified analysis of all tumor types. The subgroup analysis in adult breast cancer patients indicates that crofelemer achieved significant results in this subgroup.