Jaguar Health received approval for all proposals at the Special Meeting of Stockholders held on December 8, 2025.
The meeting highlighted the potential impact of crofelemer in extending the lives of infants with microvillus inclusion disease (MVID).
The company aims to advance its ongoing placebo-controlled trial of crofelemer for potential expedited FDA approval.
Groundbreaking PS Reduction
Crofelemer demonstrated a groundbreaking reduction of up to 37% in total parenteral support for infants with MVID.
Ongoing Clinical Trials
The company is actively engaged in ongoing investigator-initiated proof-of-concept trials to further evaluate the efficacy of crofelemer in treating MVID.
FDA Meeting Update
Jaguar Health completed a meeting with the FDA on October 2, 2025, seeking guidance on the regulatory pathway for crofelemer in treating MVID.
- The initial trial results suggest a significant breakthrough in the treatment of infants with MVID by reducing the reliance on total parenteral support.
- The potential expedited approval pathway discussed with the FDA indicates a promising future for crofelemer as a treatment option for a currently unmet medical need.
The approval of all proposals at the Special Meeting underscores the confidence of stockholders in Jaguar Health's innovative initiatives and potential to address critical medical conditions.