Jaguar Health reports positive results in MVID treatment trial

SAN FRANCISCO - Jaguar Health, Inc. (NASDAQ:JAGX), a small-cap pharmaceutical company with a market capitalization of $4.76 million and impressive gross margins of 82%, announced Monday that its novel crofelemer powder formulation for treating microvillus inclusion disease (MVID) has shown a 37% reduction in total parenteral support in an ongoing investigator-initiated trial in the United Arab Emirates.

The company recently held a Type C Meeting with the FDA on October 2 to discuss advancement of its clinical trial for the treatment of MVID, an ultrarare pediatric disorder affecting an estimated 100-200 patients worldwide. MVID is characterized by severe malabsorption requiring life-sustaining parenteral support, with no currently approved treatments.

According to Pravin Chaturvedi, Jaguar’s Chief Scientific Officer, the company sees "potential opportunities to advance the development program" following what it described as a collaborative discussion with the FDA. The company plans to make selected amendments to its clinical study and continue interactions with the regulatory agency.

The UAE trial showed a 37% reduction in parenteral support and a 30% reduction in total parenteral nutrition, improvements from the previously reported 27% reduction at 12 weeks. While the clinical results appear promising, InvestingPro data shows the company faces financial challenges with a current ratio of 0.95 and significant debt of $30.53 million.

An abstract describing partial results from this trial has been accepted for presentation at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Annual Meeting in November 2025.

Crofelemer has received orphan drug designations for MVID from both the FDA and European Medicines Agency. The company is currently conducting trials in the U.S., European Union, and Middle East/North Africa region, and providing the treatment through two FDA-authorized expanded access programs in the U.S.

The information in this article is based on a press release statement from Jaguar Health. For deeper insights into JAGX’s financial health and growth potential, InvestingPro offers exclusive access to 12 additional ProTips and a comprehensive analysis report, helping investors make more informed decisions about this undervalued pharmaceutical company. Get real-time updates and expert analysis with an InvestingPro subscription.

In other recent news, Jaguar Health reported a 35% increase in net revenue for Q2 2025 compared to the previous quarter, along with a 10% rise year-over-year. The company is actively expanding its product pipeline, as demonstrated by its subsidiary, Napo Pharmaceuticals, which is providing crofelemer for pediatric patients with microvillus inclusion disease under FDA-approved expanded access programs. Additionally, Jaguar Health has received a $250,000 grant from the FDA’s Center for Veterinary Medicine to support a study for its canine diarrhea treatment, Canalevia. This grant aims to secure full FDA approval for the drug, which is currently conditionally approved.

Furthermore, Jaguar Health is planning to meet with the FDA to discuss the clinical development of crofelemer for treating microvillus inclusion disease, following promising results from an investigator-initiated trial in Abu Dhabi. In terms of corporate developments, the company has extended Lucid Capital Markets’ role in its At the Market Offering Agreement until the end of 2025. This extension allows Lucid to continue as a manager alongside Ladenburg Thalmann & Co. Inc. until December 31, 2025. These recent developments highlight Jaguar Health’s ongoing efforts in product development and regulatory engagement.

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