SAN FRANCISCO - Jaguar Health, Inc. (NASDAQ:JAGX) has received a renewal from the U.S. Food and Drug Administration (FDA) for the conditional approval of its canine-specific drug, Canalevia-CA1, to treat chemotherapy-induced diarrhea (CID) in dogs. The extension, effective until December 21, 2025, allows the company to continue marketing the product while pursuing full FDA approval.
Canalevia-CA1, a crofelemer delayed-release tablet, was conditionally approved by the FDA in December 2021. Conditional approval permits the sale of the drug with the requirement that the company demonstrates active progress toward "substantial evidence of effectiveness." Dr. Michael Guy, Jaguar's Vice President of Preclinical and Nonclinical Studies, expressed satisfaction with the FDA's decision, citing the importance of Canalevia-CA1 for the veterinary community and dogs suffering from CID.
CID is a common side effect of cancer treatment in dogs, with studies indicating it as one of the three most prevalent adverse reactions. The American Veterinary Medical (TASE:PMCN) Association notes that approximately one in four dogs will develop cancer at some point in their lives. Managing CID is critical for the continuity of cancer treatment in canines.
Jaguar Health has reached an agreement with the FDA on the design and conduct of a clinical field study aimed at securing full approval for Canalevia-CA1. The drug is available in the U.S. through multiple leading veterinary distributors, including Chewy (NYSE:CHWY).
The product is the only FDA conditionally approved oral plant-based prescription treatment for CID in dogs, derived from the Croton lechleri tree. Jaguar Health emphasizes its commitment to supporting the quality of life for animals undergoing cancer treatment.
Safety information for Canalevia-CA1 advises against use in dogs with known hypersensitivity to crofelemer and recommends ruling out infectious causes of diarrhea before use. The most common adverse reactions reported include decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.
This news is based on a press release statement from Jaguar Health, Inc.
In other recent news, Jaguar Health has reported significant advancements in its pharmaceutical developments. The company has observed a 16% increase in net revenue for Q2 2024, reaching $2.72 million, despite a reported net loss of $8.8 million in non-GAAP recurring EBITDA. Jaguar Health has also secured new patents in Jordan and Hong Kong for the use of crofelemer, a plant-based prescription drug, in treating short bowel syndrome and related conditions.
Findings from two independent studies suggest benefits of crofelemer for patients with chronic refractory diarrhea. In the company's Phase 3 OnTarget trial, crofelemer showed significant benefits for adult breast cancer patients experiencing diarrhea due to cancer therapy. Furthermore, Jaguar Health has recently hired Susan Krizancic, a veteran of the biopharmaceutical industry, as National Sales Director for its subsidiary, Napo Pharmaceuticals.
The company has also announced the U.S. commercial launch of Gelclair, an FDA-approved treatment for oral mucositis, a common side effect of cancer therapy. These are among the recent developments at Jaguar Health.
InvestingPro Insights
While Jaguar Health's renewal for Canalevia-CA1's conditional approval is a positive development, investors should consider the company's financial position. According to InvestingPro data, Jaguar Health has a market capitalization of just $9.84 million, reflecting its small-cap status in the pharmaceutical industry.
The company's revenue for the last twelve months as of Q2 2023 stood at $10.19 million, with a concerning revenue growth decline of -7.89% over the same period. This suggests that despite the potential of Canalevia-CA1, Jaguar Health is facing challenges in generating sustainable growth.
InvestingPro Tips highlight some critical aspects of the company's financial health. One tip indicates that Jaguar Health is "quickly burning through cash," which could be a concern for investors considering the capital-intensive nature of drug development and approval processes. Another tip points out that the company "operates with a significant debt burden," which may impact its ability to fund future research and development efforts.
It's worth noting that analysts do not anticipate the company to be profitable this year, as per another InvestingPro Tip. This aligns with the reported operating income margin of -308.15% for the last twelve months as of Q2 2023, indicating significant operational losses.
For investors interested in a more comprehensive analysis, InvestingPro offers 11 additional tips for Jaguar Health, providing a deeper understanding of the company's financial situation and market performance.
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