Jaguar Health’s Italian subsidiary, Napo Therapeutics, has submitted a formal request to the European Medicines Agency (EMA) for scientific advice on pursuing approval of Canalevia, a crofelemer‑based delayed‑release tablet, for the treatment of general diarrhea in dogs. The request is directed to the EMA’s Committee for Veterinary Medicinal Products (CVMP) and will be discussed in a scheduled meeting in March 2026.
Canalevia, which is already conditionally approved by the U.S. Food and Drug Administration for chemotherapy‑induced diarrhea in dogs, is based on a 2017 study involving 200 dogs. While the original study did not meet its primary endpoint, a simplified analysis showed significantly better outcomes than placebo, providing the data foundation for the EMA submission.
The EU represents a sizable opportunity for Jaguar Health. With an estimated 69 million dogs in the European Union, a product that addresses a common veterinary condition could generate substantial revenue. Expanding Canalevia beyond the United States would diversify the company’s commercial portfolio and reduce its reliance on the U.S. market, where the drug is only approved for a niche indication.
Financially, Jaguar Health reported Q3 2025 revenue of $3.1 million, a 4% increase from the $3.0 million earned in Q2 2025 and equal to the $3.1 million earned in Q3 2024. The net loss for the quarter was $9.5 million, an improvement over the $9.9 million loss in Q3 2024. Management attributed the revenue growth to a series of business‑development partnerships and a focus on late‑stage health products, while the loss reflects ongoing investments and cash burn in pursuit of new approvals.
CEO Lisa Conte emphasized that securing a partner to fund and execute global development and commercialization of Canalevia is a top priority. She described 2025 as a “year of convergence of key clinical and regulatory catalysts,” underscoring the company’s intent to accelerate its pipeline and broaden its market reach.
The EMA meeting in March 2026 will determine the regulatory pathway for Canalevia’s EU approval. Jaguar Health’s current ratio of 0.81 and continued cash burn highlight the financial pressure accompanying its expansion efforts, making the partnership search critical to sustaining its growth trajectory.
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