On December 10, 2025, the U.S. Food and Drug Administration extended the conditional approval of Jaguar Health, Inc.’s Canalevia‑CA1, a crofelemer‑based tablet that treats chemotherapy‑induced diarrhea in dogs. The renewal keeps the product on the market through December 21, 2026, while the company completes a confirmatory effectiveness trial that is expected to finish in February 2026.
Canalevia‑CA1’s renewal marks the fifth and final year under the FDA’s conditional approval pathway, which allows veterinary drugs to reach market quickly while the sponsor gathers full effectiveness data. The upcoming trial completion is a critical milestone; a successful outcome would enable Jaguar to seek full approval and secure a longer‑term revenue stream for its animal‑health segment.
Jaguar Health’s Q3 2025 financials show revenue of $3.1 million, up 4% from the $2.97 million reported in Q2 2025 and equal to the $3.1 million earned in Q3 2024. The company posted a net loss of $9.5 million, a modest improvement from the $9.9 million loss in Q3 2024. The revenue growth was driven by sales of prescription and non‑prescription products, including license revenue, while the loss reflects ongoing investment in product development and regulatory activities.
The renewal was welcomed by investors, who viewed the extension as a positive signal that Jaguar’s flagship product remains compliant with safety and efficacy standards. The announcement reinforced confidence in the company’s ability to maintain market access for Canalevia‑CA1 while it completes the final data requirements.
CEO Lisa Conte emphasized that the renewal underscores Jaguar’s commitment to improving the quality of life for dogs undergoing cancer treatment. Dr. Michael Guy, Vice President of Preclinical and Non‑clinical Studies, noted that the confirmatory trial is on track and that the data set will support a full FDA approval application in the near future.
With the conditional approval extended, Jaguar Health can continue to generate revenue from Canalevia‑CA1 and focus on scaling its animal‑health portfolio. The company’s financial trajectory remains under pressure from ongoing losses, but the renewal provides a critical bridge to a potential full approval that could stabilize the segment’s revenue stream and enhance long‑term growth prospects.
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