JAGX News & Events

Jaguar Health completed the company's ongoing effectiveness study of crofelemer delayed-release tablets for the treatment of chemotherapy-induced diarrhea in dogs. Crofelemer, under the name Canalevia-CA1, is currently conditionally approved for the sole indication of treating CID in dogs. The approval for Canalevia CA-1 will expire on December 21, 2026. In the second quarter of 2026 Jaguar plans to submit and file the results of the company's effectiveness study and the positive results of a study of crofelemer delayed-release tablets for treatment of CTD in dogs receiving neratinib - a targeted tyrosine kinase inhibitor chemotherapy agent. "We're very pleased that enrollment has concluded for this study, which is being undertaken at veterinary oncology clinics around the US. The FDA granted renewal of the conditional approval for Canalevia-CA1 for a fifth and final year, through December 21, 2026, for the treatment of CID in dogs. In order to receive a full veterinary drug approval for the indication of CID beyond Dec. 21, 2026, Jaguar must complete and file a successful effectiveness study," said Dr. Michael Guy, Jaguar's Vice President of Preclinical and Nonclinical Studies. "The 28-day study in dogs receiving neratinib was designed to evaluate the scientific rationale for the use of crofelemer tablets in reducing the severity and incidence of diarrhea in cancer patients receiving neratinib, a targeted therapy known to cause significant diarrhea. The study demonstrated that crofelemer dosing resulted in a 30% reduction in the incidence and severity of diarrhea in participating dogs, which was statistically significant."

Reports net product revenue $11.5M vs. $11.7M last year. Mytesi prescription volume decreased approximately 3.7% in the year 2025 over 2024, by approximately 5.8% in the fourth quarter of 2025 over the third quarter of 2025, and by approximately 12.2% in the fourth quarter of 2025 over the fourth quarter of 2024. Prescription volume differs from invoiced sales volume, which reflects, among other factors, varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels.

Jaguar Health family company Napo Pharmaceuticals announced that, based on the FDA support for Napo's protocol amendment for its clinical trial to evaluate the safety and efficacy of its novel crofelemer powder-for-oral-solution formulation in pediatric patients with intestinal failure due to MVID, an ultrarare pediatric disorder, Napo plans to initiate a single-blind extension phase for the trial. The extended treatment period has the potential to improve clinical benefit of crofelemer through reduction of parenteral support requirements, which may result in disease progression-modification of MVID. The dose selection for the single-blind extension phase will be determined by the study's independent Data Monitoring Committee, which will ensure that the study clinicians and Napo personnel will remain blinded. Currently, approximately 30% of the participating MVID patients have completed the study's double-blind treatment phase and the clinical investigators are supporting the patients' participation in the single-blind extended phase.