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Proof-of-Concept Data for Rare Disease Indications MVID and SBS-IF for Jaguar Health's Crofelemer to be Presented at April 2025 ELITE PED-GI Congress

1. Jaguar Health's crofelemer granted Orphan Drug Designation for rare diseases. 2. Preliminary trial results of crofelemer will be presented at an upcoming congress.

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Why Bullish?

The Orphan Drug Designation for crofelemer enhances its market potential, similar to past FDA designations that have benefitted firms with limited competition in niche markets, such as Vertex Pharmaceuticals with cystic fibrosis treatments.

How important is it?

The progress in crofelemer's trials and relevant designations indicates potential revenue growth and enhances investor perception, driving interest in JAGX.

Why Long Term?

The presentation of preliminary trial results could lead to future FDA approvals, impacting growth opportunities over years, akin to how early results for Vertex led to sustained stock growth.

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Crofelemer, a novel plant-based anti-secretory prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines Agency (EMA) for both short bowel syndrome (SBS) and microvillus inclusion disease (MVID) and is being evaluated to serve as a potential therapeutic option to manage intestinal failure in these patients There are currently no approved drug treatments for MVID, an ultrarare pediatric disease characterized by severe diarrhea and malabsorption that requires intensive parenteral support for nutritional and fluid management Proof-of-concept data in MVID from this study would provide support for crofelemer's potential inclusion in the EMA's PRIME program for novel medicines targeting unmet medical needs and the FDA's Breakthrough Therapies program SAN FRANCISCO, CA / ACCESS Newswire / April 17, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics today announced that preliminary results from the ongoing pediatric investigator-initiated trial (IIT) of a novel liquid formulation of crofelemer, Jaguar's novel plant-based anti-secretory prescription drug, for various congenital diarrheal disorders (CDD), including MVID and SBS with intestinal failure (SBS-IF), will be presented by Dr. Mohamad Miqdady at the April 24-26, 2025 Annual ELITE PED-GI Congress in Abu Dhabi in the United Arab Emirates. MVID and SBS-IF, rare orphan diseases requiring intensive parenteral nutrition and support, have severe morbidity and mortality implications and impact the quality of life of both patients and their caregivers.

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