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Jaguar Health (JAGX) investor relations material
Jaguar Health Emerging Growth Conference 88 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Key product and regulatory updates
FDA renewed conditional approval for Canalevia-CA1, a plant-based drug for chemotherapy-induced diarrhea in dogs.
Conditional approval requires annual review and a confirmatory study within five years for full approval.
Received a $250,000 grant to support the pivotal trial for full approval.
Filed with the EMA in Europe to seek advice on approval for all acute diarrhea in dogs, potentially based on a single pivotal trial.
No conditional approval pathway exists in the EU, so full approval could expand access to 37 countries.
Market opportunity and business development
Acute diarrhea affects about 15% of the 90 million dogs in the US, representing a significant market.
Expansion from chemotherapy-induced to general acute and chronic diarrhea in dogs is a major growth target.
Business development efforts are underway to partner with animal health companies for broader indications.
Stock price increased 20%-25% following recent announcements.
Focus on non-dilutive funding and partnerships to support expansion.
Scientific and clinical insights
Canalevia-CA1 uses crofelemer, the same active ingredient as the human drug for chronic diarrhea in HIV/AIDS patients.
Crofelemer normalizes chloride ion flow in the gut, reducing water loss and dehydration.
Current standard treatments like metronidazole are not approved or tested in dogs, and there is a push to reduce antibiotic use.
The mechanism of action is conserved across mammals, supporting cross-species efficacy.
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