It may not be dinner-table-talk for most, but chemotherapy-induced diarrhea (CID) in dogs is a problem that Jaguar Health (NASDAQ:JAGX) is looking to provide a solution for.
Shares of the San Francisco-based natural-products pharmaceuticals company are on a tear on Thursday as the best stock listed on the Nasdaq exchange following positive feedback from the U.S. Food and Drug Administration on Canalevia, Jaguar's lead experimental veterinary drug.
Based upon its review of the data from Jaguar's successfully completed pilot study of Canalevia for CID, the FDA's Center for Veterinary Medicine (CVM) has indicated that the Jaguar's Reasonable Expectation of Effectiveness Technical Section is complete towards conditional approval of Canalevia for the indication.
Canalevia is a canine-specific oral formulation of crofelemer, an active pharmaceutical ingredient derived from latex from the bark of the sustainably harvested Croton lechleri tree, a tree native to northwestern South America.
In January 2013, the FDA approved Napo Pharmaceuticals' crofelemer (brand name Mytesi, 125 mg delayed-release tablets) for the treatment of non-infectious diarrhea in HIV/AIDS adult patients on anti-retroviral therapy (ART).
In July 2017, Jaguar merged with Napo. While the company works on developing drugs for humans, it was not going to overlook the opportunity for CID in dogs, according to president and CEO Lisa Conte.
Jaguar previously received Minor Use in a Minor Species (MUMS) designation from the FDA for Canalevia™ for CID in dogs. MUMS is part of the process towards to Canalevia being awarded conditional approval one day, allowing the product to be commercialized while additional data is collected to seek a full approval.
With two of the four technical sections of the application for conditional approval now completed, Jaguar is optimistic it will be able to conduct a commercial launch in mid-2019. The company also has been told by the CVM that Canalevia qualifies for minor use for the treatment of exercise-induced diarrhea (EID) in dogs. If it can obtain conditional approval for EID as well, Jaguar expects launching both products next year about the same time.
Shares of JAGX have been muddling around lows in the area of 12-13 cents with some abbreviated pops to as high as 20 cents since December. Shares catapulted as high as 44 cents Thursday from Wednesday's close at 14 cents on the FDA news, marking the highest point since September 29. The stock has slipped back some to 30.6 cents, still holding a gain of nearly 120% with about 45 minutes left in the trading day.