Jaguar Health provides drug for expanded access to treat rare disease

Published 30/09/2025, 14:14
Jaguar Health provides drug for expanded access to treat rare disease

SAN FRANCISCO - Jaguar Health (NASDAQ:JAGX), a small-cap pharmaceutical company with a market capitalization of $4.59 million and an impressive gross profit margin of 82%, announced Tuesday that its family company Napo Pharmaceuticals is providing crofelemer powder for oral solution to treat two pediatric patients with microvillus inclusion disease (MVID) under expanded access programs authorized by the FDA. According to InvestingPro data, the company has shown revenue growth of 16% over the last twelve months, despite operating with significant debt obligations.

The programs are being conducted under separate Single-Patient Investigational New Drug applications in the United States, according to the company’s press release statement.

The novel formulation is being provided as an investigational drug for these patients with MVID, an ultrarare disease with an estimated worldwide prevalence of about 200 patients.

Preliminary results from an ongoing investigator-initiated trial in Abu Dhabi showed that crofelemer reduced required total parenteral nutrition and supplementary intravenous fluids by up to 27% in an MVID patient and up to 12.5% in a short bowel syndrome with intestinal failure (SBS-IF) patient. While the clinical results appear promising, InvestingPro analysis reveals multiple financial challenges ahead, with analysts forecasting continued losses for the current fiscal year. Get deeper insights into Jaguar Health’s financial health and access 10+ additional ProTips with an InvestingPro subscription.

Jaguar is currently supporting two independent proof-of-concept trials and conducting two placebo-controlled studies of crofelemer in patients with intestinal failure due to MVID and SBS-IF across multiple regions.

Additional proof-of-concept results from investigator-initiated trials are expected later in 2025, with data from the placebo-controlled studies anticipated in 2026.

MVID and SBS-IF patients suffer from severe diarrhea and dehydration, often requiring total parenteral nutrition for up to 20 hours daily, which carries significant risks including infections and organ problems.

Crofelemer is a botanical drug extracted from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program for the drug under fair trade practices. Despite recent stock volatility, analyst consensus remains bullish with price targets significantly above current levels. Discover comprehensive analysis and Fair Value estimates for Jaguar Health and 1,400+ other stocks through InvestingPro’s detailed research reports.

In other recent news, Jaguar Health reported a significant 35% increase in net revenue for Q2 2025 compared to the previous quarter, and a 10% rise year-over-year. Despite these financial gains, the company continues to face operational losses. Additionally, Jaguar Health received a $250,000 grant from the U.S. Food and Drug Administration’s Center for Veterinary Medicine. This grant will support a confirmatory study for its canine diarrhea treatment, Canalevia, which is conditionally approved for chemotherapy-induced diarrhea in dogs.

In a related development, Jaguar Health’s subsidiary, Napo Pharmaceuticals, is set to meet with the FDA to discuss crofelemer’s clinical development for treating microvillus inclusion disease, a rare pediatric disorder. Initial results from a trial in Abu Dhabi show promising reductions in the need for parenteral nutrition. Furthermore, Jaguar Health has extended Lucid Capital Markets’ role in its At the Market Offering Agreement until the end of 2025. If not extended further, Ladenburg Thalmann & Co. Inc. will become the sole manager under this agreement.

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