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SAN FRANCISCO - Jaguar Health, Inc. (NASDAQ:JAGX) plans to pursue European regulatory approval for its canine diarrhea treatment Canalevia, according to a company statement released Wednesday. The micro-cap pharmaceutical company, currently valued at $4.04 million, has maintained a strong gross profit margin of 82.34% despite challenging market conditions. According to InvestingPro analysis, the company faces significant cash burn challenges while operating with substantial debt.
The company is seeking approval from the European Medicines Agency’s Committee for Veterinary Medicinal Products for Canalevia to treat general diarrhea in dogs across the European Union, where an estimated 104 million dogs resided as of 2022.
Canalevia contains crofelemer, a plant-based drug that modulates chloride channels in the gastrointestinal tract. The medication is currently conditionally approved by the U.S. Food and Drug Administration under the name Canalevia-CA1 specifically for chemotherapy-induced diarrhea in dogs.
Lisa Conte, Jaguar’s Founder and CEO, said the company aims to obtain EU approval based on data from a completed study involving 200 dogs with general diarrhea. While the study didn’t meet its original primary endpoint, the company reports that when analyzed using a revised endpoint, the data shows "dogs treated with Canalevia had significantly better outcomes" compared to placebo-treated animals.
Jaguar is currently in discussions with multiple potential animal health company partners to collaborate on bringing Canalevia to market globally for general diarrhea treatment. The company estimates U.S. veterinarians see approximately six million annual cases of acute and chronic diarrhea in dogs.
According to the company, diarrhea ranks as one of the most common reasons dogs are brought to veterinarians and is the second most common reason for emergency veterinary visits, yet there is currently no FDA-approved drug specifically for general, non-infectious diarrhea in dogs.
The information in this article is based on a press release statement from Jaguar Health.
In other recent news, Jaguar Health reported a challenging first quarter of 2025, with net revenue decreasing by 6% year-over-year to $2.2 million. Despite this, the company is advancing its pipeline with a focus on rare diseases, including ongoing trials for crofelemer in pediatric microvillus inclusion disease (MVID) and short bowel syndrome. Jaguar Health has extended the maturity date for $2.57 million in convertible promissory notes to January 30, 2026, as part of its financial strategy. The company also announced a $1.5 million direct offering, with H.C. Wainwright & Co. as the exclusive placement agent. Additionally, Jaguar Health is seeking FDA orphan drug designation for crofelemer to treat cancer therapy-related diarrhea in metastatic breast cancer patients. This move follows a productive meeting with the FDA, where significant results from the Phase 3 OnTarget trial were discussed. The company aims to initiate an expanded access program for patients with cancer therapy-related diarrhea who may not qualify for the pivotal treatment trial.
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