Company remains sharply focused on its ongoing rare disease intestinal failure global development program for microvillus inclusion disease (MVID) and SBS for crofelemer powder for oral solution, targeting an NDA filing for MVID mid-2027

SAN FRANCISCO, CA / ACCESS Newswire / September 22, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that the U.S. Food and Drug Administration (FDA) has granted Napo's request for a waiver of the fee associated with the Prescription Drug User Fee Act (PDUFA) for Mytesi® (crofelemer delayed-release tablets) for the 2027 fiscal year. Mytesi is an FDA-approved prescription drug for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy, and is currently commercialized in the U.S. by Future Pak, LLC.

Jaguar was also granted a waiver of the fee by the Center for Veterinary Medicine of the FDA for the 2027 fiscal year for Canalevia®-CA1, Jaguar's conditionally approved prescription drug for the treatment of chemotherapy-induced diarrhea in dogs, which is also commercialized in the U.S. by Future Pak, LLC.

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