← Catalyst calendarJAGX biotech catalysts & pipeline
JAGUAR HEALTH INC · Data as of 2026-09-08
Upcoming catalysts
crofelemer — NDA/BLA submission
H2 2026
In the second half of 2026, based on discussions with the FDA in May 2025, the company plans to submit to the FDA the final clinical study report (CSR) for the OnTarget trial together with additional details of the responder analysis in the cohort of breast cancer patients, along with a patient survey evaluating clinically meaningful reductions in the frequency of weekly loose/watery stools for patients metastatic cancer patients receiving targeted therapies with or without standard chemotherapy.
Source filingcrofelemer — Topline data
late 2026
We expect that enrollment will continue in 2025 for the MVID Phase 2 trial and the Phase 2 trial for SBS-IF, with data expected in late 2026 for both trials.
Source filingcrofelemer — NDA/BLA submission
Q2 2027
Company remains sharply focused on its ongoing global development program for crofelemer for rare intestinal failure (IF) diseases; as announced , presentation at ESPGHAN 2026 described additional groundbreaking results of evaluation of crofelemer as adjunctive oral therapy for the treatment of pediatric IF, which demonstrate reduction of parenteral support normalized to body weight of up to 48% in patient with the ultrarare microvillus inclusion disease (MVID); company expects clinical package for NDA for MVID to be ready by end of 2026, allowing submission of NDA in Q2 2027
Source filingExplore the free biotech catalyst calendar