SAN FRANCISCO - Jaguar Health, Inc. (NASDAQ:JAGX), a commercial-stage pharmaceutical company with a market capitalization of approximately $11 million, and its subsidiary Napo Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) to crofelemer for the treatment of cholera-related diarrhea. According to InvestingPro data, the company maintains a healthy gross profit margin of 80%, though it faces significant operational challenges. This designation is significant as it provides various development incentives and a seven-year period of marketing exclusivity in the U.S. upon potential approval.
Cholera, an acute diarrheal illness caused by the bacterium Vibrio cholerae, leads to severe dehydration and can be fatal without prompt treatment. While cholera has a low incidence in the United States, globally it remains a serious health threat, with an estimated 1.3 to 4 million cases and 21,000 to 143,000 deaths annually.
Steven King, PhD, Jaguar's Chief Sustainable Supply, Ethnobotanical Research & IP Officer, expressed satisfaction with the FDA's decision, noting the company's plans to pursue a similar designation from the European Medicines Agency (EMA) in the future. Crofelemer's ODD status in the U.S. follows Phase 2 data presented for treating dehydration in cholera patients, which was conducted at the International Centre for Diarrhoeal Disease Research in Bangladesh.
In addition to cholera, crofelemer is involved in other rare disease-related clinical efforts, including three investigator-initiated trials and two Phase 2 studies for short bowel syndrome with intestinal failure (SBS-IF) and microvillus inclusion disease (MVID). The first patient dosing in these studies is expected between December 2024 and the first quarter of 2025, with results potentially available in the second quarter of 2025.
Crofelemer, derived from the Croton lechleri tree, has also received ODD for both MVID and SBS-IF from the FDA and EMA. Jaguar is also exploring the potential of NP-300, a second-generation anti-secretory agent, for the treatment of diarrhea in cholera, which could qualify for a Tropical Disease Priority Review Voucher. While the company's development pipeline shows promise, InvestingPro analysis reveals challenging financial metrics, including significant cash burn and debt concerns. For detailed insights into Jaguar Health's financial health and future prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
Jaguar Health is a commercial stage pharmaceuticals company specializing in developing plant-based prescription medicines for gastrointestinal distress, and Napo Pharmaceuticals focuses on human prescription pharmaceuticals for gastrointestinal symptoms across various disease states. With annual revenue of $10.48 million and a current ratio of 1.84, the company shows potential despite current market challenges. InvestingPro's Fair Value analysis suggests the stock may be undervalued at current levels, presenting a potential opportunity for investors willing to accept the associated risks.
This announcement is based on a press release statement from Jaguar Health, Inc.
In other recent news, Jaguar Health, Inc. has announced its intention to seek a partner for the development and commercialization of its new prescription drug candidate, NP300, aimed at treating non-infectious diarrhea in dogs. This follows the company's recent extension of conditional approval by the FDA for Canalevia®-CA1, their first-generation antisecretory drug for chemotherapy-induced diarrhea in canines. Jaguar Health also plans to attend the Pet Connect conference in Hollywood, California, aiming to discuss potential NP300 partnership opportunities.
On the financial front, Jaguar Health reported a net revenue of approximately $3.1 million for the third quarter of 2024, marking a 14% increase from the previous quarter and an 11% increase from the same period last year. However, the company also reported a net loss of $9.9 million, albeit with reduced operational loss compared to the previous year.
In addition to these developments, Jaguar Health is preparing for the presentation of Phase III OnTarget trial results, the advancement of crofelemer in rare diseases, and the commercial launch of Gelclair for oral mucositis treatment. The company anticipates significant catalysts in the next six months, including the development of crofelemer for cancer therapy-related diarrhea. Despite a mixed financial picture, these recent developments show Jaguar Health's continued commitment to addressing unmet patient needs and striving for financial stability.
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