Source: Kythera Biopharmaceuticals,
Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What's happening: Shares of Kythera Biopharmaceuticals (NASDAQ: KYTH) soared higher by as much as 20% ahead of a key FDA advisory panel committee meeting next week.
Why it's happening: The FDA's advisory panel is scheduled to discuss the company's drug ATX-101 for the treatment of double chin on March 9th. If the advisory panel votes in favor of approving ATX-101 at this meeting, it could clear the way for an official FDA green-light later this year.
ATX-101 is an injectible therapy that can be used to eliminate the appearance of a second chin. If the drug is approved, it will compete in an increasingly lucrative market for self-image enhancing therapies that includes Allergan's top selling Botox, a multibillion dollar a year drug that is not approved to treat the indication for which ATX-101 is pursuing.
After reporting positive results in clinical trials, Kythera submitted its filing for FDA approval for ATX-101 last May. In ATX-101's trials, the drug, which is a formulation of a molecule that breaks down fat, visibly reduced the amount of fat under the chin. Overall, the trials evaluating ATX-101 included 2,600 patients.
Now what: There's no guarantee that the FDA will follow the advice of its advisory panel, but it often does. That suggests that investors should be watching closely for how the panel votes next week, as well as the margin of victory or defeat. If the committee does vote in favor of ATX-101 and the FDA eventually approves it, Kythera believes that it could be a hit. According to the company, the facial aesthetics market will be worth $4.7 billion per year in 2018. Whether or not that outlook is correct remains to be seen. In the meantime, the FDA is expected to offer up its official decision on ATX-101 on May 13th.
