Heads up, dog lovers. Today, Jaguar Health (NASDAQ:JAGX) announced that it had received conditional approval from the U.S. Food and Drug Administration (FDA) for its Canalevia drug. Canalevia is a canine-specific version of crofelemer that works to treat chemotherapy-induced diarrhea (CID). Crofelemer is a plant-based drug that is “sustainably harvested from the Croton lechleri tree.”
So, what exactly does conditional approval mean in the animal world? The FDA will grant this form of approval only for animal drugs to be used for minor species or for animal drugs with minor uses in a major species. Major animals are defined as horses, dogs, cats, cattle, pigs, turkeys, and chickens. Furthermore, minor species are defined as any animal that is not a major species. Minor use in a major species is defined as the use of a drug for a condition or disease that occurs:
- “Infrequently and in only a small number of animals each year; or
- In a limited geographic area and in only a small number of animals each year.”
A “small number” for dogs means that less than 70,000 dogs a year will be affected by the condition or disease. Therefore, we can assume that less than 70,000 dogs per year are affected by CID since Jaguar received the minor use in a major species (MUMS) designation from the FDA. Canalevia is the first and only CID treatment product to receive FDA approval thus far.
With those definitions out of the way, let’s take a look into what this conditional approval means for JAGX stock.
JAGX Stock: 5 Things to Know About Canalevia Approval
- Studies have shown that CID is one of three most-common side effects in dogs after receiving cancer treatment.
- According to the American Veterinary Medical Association, almost 50% of dogs over age 10 will develop some form of cancer.
- CEO Lisa Monte added that “In a third-party survey of dog and cat owners, the majority of participants (58%) indicated that they believed that the benefits of chemotherapy did not counterbalance the impact of the potentially negative side effects which animals may experience during treatment.”
- The Canalevia drug will be available by prescription only in a delayed-release tablet. Further plans for commercialization will be revealed in January 2022.
- While this is great news, Jaguar Health remains a penny stock that is susceptible to volatile price movements. Shares have declined by more than 45% year t0 date, bringing today’s market capitalization to $65 million.
On Penny Stocks and Low-Volume Stocks: With only the rarest exceptions, InvestorPlace does not publish commentary about companies that have a market cap of less than $100 million or trade less than 100,000 shares each day. That’s because these “penny stocks” are frequently the playground for scam artists and market manipulators. If we ever do publish commentary on a low-volume stock that may be affected by our commentary, we demand that InvestorPlace.com’s writers disclose this fact and warn readers of the risks.
Read More: Penny Stocks — How to Profit Without Getting Scammed
On the date of publication, Eddie Pan did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.