Jaguar Health said it plans to submit a new drug application for crofelemer powder-for-oral-solution in microvillus inclusion disease, or MVID, in late second quarter 2027, with potential U.S. approval by end-2027 if breakthrough therapy designation is granted. CEO Lisa Conte said the company aims to complete enough patients in its treatment-only blinded trial by the fourth quarter of 2026 to file for breakthrough designation, and the clinical package for the NDA is expected to be ready by end-2026. Conte highlighted ESPGHAN data showing weekly parenteral support requirements normalized to body weight were reduced by up to 48% in one MVID patient and up to 40% in two short bowel syndrome with intestinal failure patients. CFO Carol Lizak reported second quarter 2026 prescription product revenue of approximately $1.2 million, primarily from Mytesi sales at cost plus to Future Pak, and a net loss attributable to common shareholders of $12.7 million. The company also recognized a $2 million holdback payment from Future Pak and license fees of $43,000 in the quarter.
Jaguar Animal Health IncPlans to file NDA for crofelemer in MVID by mid-2027 with potential approval, and positive ESPGHAN data showing reduced parenteral support needs.
