Crofelemer

September 22, 2026: Jaguar Health (NASDAQ: JAGX) said the FDA granted Napo Pharmaceuticals a Prescription Drug User Fee Act fee waiver for fiscal 2027 for Mytesi (crofelemer delayed-release tablets), an already approved drug for symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar also said the FDA Center for Veterinary Medicine granted a fiscal 2027 fee waiver for Canalevia-CA1, its conditionally approved treatment for chemotherapy-induced diarrhea in dogs.

The release also reiterated Jaguar’s rare-disease intestinal failure development focus for crofelemer powder for oral solution, with a targeted NDA filing for microvillus inclusion disease (MVID) in mid-2027. The company said the program is also being developed for short bowel syndrome (SBS).

No new clinical efficacy data were reported; the main catalyst updates were the 2027 FDA fee waivers for marketed/conditionally approved products and the stated mid-2027 NDA filing target for crofelemer in MVID.