SAN FRANCISCO - Jaguar Health, Inc. (NASDAQ:JAGX) has announced the establishment of a new Investigational New Animal Drug (INAD) file with the U.S. Food and Drug Administration's Center for Veterinary Medicine for crofelemer, a plant-based drug intended to treat non-infectious diarrhea in dogs.
Crofelemer, marketed under the name Canalevia®-CA1, previously received conditional FDA approval in December 2021 for chemotherapy-induced diarrhea in dogs. The company is now looking to expand the drug's indication to include all forms of non-infectious diarrhea, addressing a significant unmet need in veterinary medicine.
Diarrhea is a leading cause of veterinary visits, with an estimated six million cases annually in the U.S. alone. The lack of FDA-approved anti-secretory agents for canine diarrhea highlights the potential impact of crofelemer's approval for a broader application.
Dr. Michael Guy, Jaguar's Vice President of Preclinical and Nonclinical Studies, expressed optimism about the drug's market reception for its current use and the prospect of addressing the broader issue of canine diarrhea. Jaguar plans to request a pre-submission conference with the CVM to discuss the clinical field study protocol for this new indication.
A previous study demonstrated crofelemer's efficacy over a placebo in alleviating clinical signs of secretory diarrhea in dogs. As a conditionally approved drug, Canalevia-CA1 is currently indicated for chemotherapy-induced diarrhea in dogs, with common adverse reactions including decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.
Jaguar Health is a commercial stage pharmaceuticals company focused on developing sustainably derived plant-based prescription medicines for gastrointestinal distress in both humans and animals. The company's broader portfolio includes initiatives in human pharmaceuticals and mental health treatments through its family of companies.
The information in this article is based on a press release statement from Jaguar Health, Inc.
InvestingPro Insights
As Jaguar Health, Inc. (NASDAQ:JAGX) forges ahead with its plans to expand the indications for its plant-based drug crofelemer, it's worth noting the company's financial and market performance to date. Jaguar Health's market capitalization stands at a modest $87.84 million, reflecting the size and growth stage of the company within the pharmaceutical industry. The stock's recent performance has been notably vigorous, with a significant return over the last week, as indicated by a 52.88% one-week price total return. This short-term surge is part of a broader trend, with the stock achieving a remarkable 278.57% return over the last month.
However, the financial health of the company shows some challenges. The price to book ratio is currently high at 17.71, which may suggest the stock is trading at a premium compared to its book value. This could be a point of concern for value-focused investors. Moreover, analysts have expressed skepticism about the company's profitability in the near term, as Jaguar Health has not been profitable over the last twelve months and does not pay a dividend to shareholders.
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