SAN FRANCISCO - Jaguar Health, Inc. (NASDAQ:JAGX) and its subsidiary Napo Pharmaceuticals have applied for Orphan Drug Designation (ODD) with the U.S. Food and Drug Administration (FDA) for their drug crofelemer, aimed at treating moderate-to-severe diarrhea caused by bacterial, viral, and parasitic infections, including cholera.
Cholera, a rare disease in the United States, is a focus of Jaguar's development efforts. The company anticipates results from five proof-of-concept studies for crofelemer across three continents, including the Cleveland Clinic, by 2025. These studies are targeting rare conditions such as microvillus inclusion disease (MVID) and short bowel syndrome (SBS). Data from these studies could potentially enable early patient access to crofelemer in Europe in 2025, while the company seeks approval from the European Medicines Agency (EMA) and FDA.
Crofelemer, derived from the sap of the Croton lechleri tree in the Amazon (NASDAQ:AMZN) Rainforest, has already received ODD from the FDA and EMA for MVID and SBS. The Orphan Drug Act in the U.S. and certain regulations in the EU provide incentives for the development of treatments for rare diseases, including tax credits and market exclusivity upon approval.
Steven King, PhD, of Jaguar highlighted the significance of the ODD application for cholera-related diarrhea, citing Phase 2 data from a study on the treatment's impact on dehydration in cholera patients. The company also plans to seek ODD from the EMA for this indication in the future.
Globally, cholera affects 1.3 to 4 million people annually, with 21,000 to 143,000 deaths, according to the U.S. Centers for Disease Control and Prevention. The World Health Organization reported an increase in cholera cases in 2023 compared to the previous year, classifying the global cholera resurgence as a grade 3 emergency.
Jaguar Health is a pharmaceutical company focused on developing plant-based prescription medicines for gastrointestinal distress. The company supports sustainable harvesting practices for crofelemer and works on expanding drug access through its subsidiaries, including Napo Therapeutics in Europe.
This report is based on a press release statement from Jaguar Health, Inc.
InvestingPro Insights
As Jaguar Health, Inc. (NASDAQ:JAGX) seeks to make strides with its drug crofelemer for various gastrointestinal conditions, the financial health and market performance of the company remain critical factors for investors. According to real-time data from InvestingPro, Jaguar Health currently has a market capitalization of 4.57 million USD, reflecting the size of the company in the competitive pharmaceutical landscape.
Despite the potential of crofelemer, Jaguar Health's financial metrics indicate challenges. With a negative Price to Earnings (P/E) ratio of -0.1 over the last twelve months as of Q3 2023, the company has not been profitable in this period. This is further underscored by a significant operating income margin of -307.99%, suggesting that the company's expenses far exceed its gross profit of 8.88 million USD.
Investors should also note the company's stock performance, which has seen a substantial price total return of -97.92% over the last year, according to InvestingPro data. This aligns with one of the InvestingPro Tips, indicating that the stock has fared poorly over the last month, with a 1 Month Price Total Return of -18.82%.
For those considering an investment in Jaguar Health, it is important to be aware of these financial and market performance indicators. For additional insights, there are 13 more InvestingPro Tips available for JAGX, which can be accessed at https://www.investing.com/pro/JAGX. Interested readers can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.