Jaguar Health Receives Fee Waivers from FDA

SAN FRANCISCO, CA / ACCESS Newswire / September 22, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (link) (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.