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SAN FRANCISCO - Jaguar Health, Inc. (NASDAQ:JAGX), a pharmaceutical company with an 81.88% gross profit margin and 15.95% year-over-year revenue growth, announced Tuesday that its subsidiary Napo Pharmaceuticals plans to meet with the U.S. Food and Drug Administration to discuss the clinical development program for crofelemer in treating microvillus inclusion disease (MVID), an ultrarare pediatric disorder. According to InvestingPro analysis, the company’s stock appears undervalued despite falling 93.32% over the past year.
According to the company’s press release statement, initial proof-of-concept results from an ongoing investigator-initiated trial in Abu Dhabi showed that crofelemer reduced the required total parenteral nutrition in the first participating MVID patient by up to 27%. While these clinical developments are promising, InvestingPro data reveals the company faces financial challenges, including significant cash burn and a debt-to-equity ratio of 5.55. For deeper insights into biotech company analysis, including 12+ additional ProTips and comprehensive financial metrics, explore InvestingPro’s specialized biotech research tools.
MVID is characterized by severe malabsorption that requires life-sustaining parenteral support to meet nutritional, fluid and electrolyte requirements. Currently, there are no approved drug treatments for the condition.
"A core Napo goal for this meeting is to obtain input from the FDA on the clinical program and potential expedited regulatory pathways for this rare orphan indication," said Pravin Chaturvedi, Napo’s and Jaguar’s Chief Scientific Officer.
The company is supporting an independent proof-of-concept trial in pediatric intestinal failure patients at Sheikh Khalifa Medical City in Abu Dhabi. Simultaneously, Jaguar is conducting a placebo-controlled Phase 2 study of crofelemer in pediatric MVID patients with intestinal failure at sites in the U.S., European Union, and Middle East/North Africa regions.
An abstract describing the initial results has been accepted for presentation at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Annual Meeting taking place November 5-8, 2025 in Chicago.
The company noted that given the ultrarare nature of MVID, even a small number of patients showing benefit with crofelemer may allow exploration of pathways for expedited regulatory approval. With the next earnings report due on August 29, investors can access detailed analysis and Fair Value estimates through InvestingPro’s comprehensive research reports, which provide expert insights on over 1,400 US stocks, including specialized coverage of biotech companies like Jaguar Health.
In other recent news, Jaguar Health reported a significant increase in net revenue for the second quarter of 2025, with a 35% rise from the previous quarter and a 10% increase compared to the same period last year. Despite the revenue boost, the company continues to face operational losses as it works on expanding its product pipeline. In another development, Jaguar Health announced an amendment to its At the Market Offering Agreement, extending Lucid Capital Markets’ role as a manager under the agreement until December 31, 2025. This extension is effective retrospectively from June 30, 2025. If not amended further, Ladenburg Thalmann will become the sole manager after this date. These recent developments highlight Jaguar Health’s ongoing strategic adjustments and financial performance.
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