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Jaguar Health Reports Approval of All Proposals at December 2025 Special Meeting of Stockholders
Accessnewswire· 2025-12-08 21:15
Jaguar CEO Lisa Conte presenting December 10 from 3:25pm - 3:35pm Eastern at the Emerging Growth Conference to provide updates on near-term catalysts; Click here to register Initial results of ongoing investigator-initiated proof-of-concept trial demonstrate crofelemer can potentially extend the lives of infants born with intestinal failure due to microvillus inclusion disease (MVID), reducing the volume of the total parenteral support (PS) necessary for them to survive, though with associated toxicity; Gro ...
In Support of Possible Expedited Approval Pathway for Crofelemer for Treatment of Microvillus Inclusion Disease (MVID), Jaguar Health Submits Amended Protocol to FDA for Ongoing Placebo-Controlled Clinical Trial
Accessnewswire· 2025-11-20 14:00
Core Insights - Crofelemer has the potential to extend the lives of patients with microvillus inclusion disease (MVID), a rare genetic disorder affecting infants and children [1] - The company has submitted an amended protocol to the FDA for a placebo-controlled clinical trial of crofelemer in pediatric MVID patients, aiming for expedited approval [1] - MVID patients face a lethal natural history and require parenteral support, which can be reduced by up to 37% with crofelemer, marking a significant breakthrough [1] Company Developments - Jaguar Health, Inc. and its subsidiary Napo Pharmaceuticals are actively pursuing the development of crofelemer for treating intestinal failure in MVID patients [1] - The ongoing clinical trial is a critical step towards obtaining approval for a treatment that currently has no approved options in any region [1] Industry Context - The lack of approved treatments for MVID highlights a significant unmet medical need in the pediatric population affected by this disorder [1] - The potential reduction of parenteral support by crofelemer could alleviate associated toxicities and comorbidities, improving the quality of life for these patients [1]