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 crofelemer orphan designation. Drug status for the treatment of cholera-related diarrhea. According to InvestingPro data, the company has a solid gross margin of 80% but faces significant operational challenges. This designation is important because it offers various development incentives and seven years of market exclusivity in the US upon possible approval.
Cholera, an acute diarrheal illness caused by the bacterium Vibrio cholerae, causes severe dehydration and can be fatal without prompt treatment. While cholera is rare in the United States, it remains a serious health threat worldwide, with an estimated 1.3 to 4 million cases and 21,000 to 143,000 deaths per year.
Dr. Steven King, Chief Sustainable Supply, Ethnobotanical Research & IP Officer at Jaguar, said he was extremely pleased with the FDA's decision and noted the company's plans to seek a similar designation from the European Medicines Agency (EMA) in the future. The U.S. orphan drug designation for crofelemer follows Phase 2 data on the treatment of dehydration in cholera patients conducted at the International Center for Diarrheal Disease Research in Bangladesh.
In addition to cholera, crofelemer is also involved in other rare disease clinical trials, including three investigator-initiated trials and two phase 2 trials 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 orphan drug designation for MVID and SBS-IF from the FDA and EMA. Jaguar is also exploring the potential of NP-300, a second-generation anti-secretory agent, to treat diarrhea in cholera, which could be eligible for a Tropical Disease Priority Review Voucher. While the company's development pipeline appears promising, InvestingPro analysis shows challenging financial metrics, including significant cash burn and debt concerns.
Jaguar Health is a commercial-stage pharmaceutical company specializing in the development of herbal prescription medications for gastrointestinal disorders. Napo Pharmaceuticals focuses on prescription human medicines for gastrointestinal symptoms of various medical conditions. 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, representing a potential opportunity for risk-taking investors.
This announcement is based on a press release from Jaguar Health, Inc.
In other recent news, Jaguar Health, Inc. announced its intention to seek a partner to develop and commercialize its prescription drug candidate NP300 for the treatment of non-infectious diarrhea in dogs. This follows the FDA's recent conditional approval extension for Canalevia®-CA1, its first-generation antisecretory drug for chemotherapy-induced diarrhea in dogs. Jaguar Health also plans to attend the Pet Connect conference in Hollywood, California to discuss potential NP300 partnership opportunities.
On the financial side, Jaguar Health reported net sales of approximately $3.1 million for the third quarter of 2024, up 14% from the previous quarter and 11% from the same period last year. However, the company also posted a net loss of $9.9 million, albeit with reduced operating losses compared to the previous year.
In addition to these developments, Jaguar Health prepared to present results from the Phase III OnTarget trial, is advancing the development of crofelemer in rare diseases, and plans to commercially launch Gelclair for the treatment of oral mucositis. The company expects powerful catalysts in the next six months, including the development of crofelemer for cancer therapy-related diarrhea. Despite a mixed financial picture, these recent developments demonstrate Jaguar Health's continued commitment to meeting unmet patient needs and pursuing financial stability.
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