What's next for Kythera after unanimous FDA rec for its double-chin injection?
- ATX-101, developed by Kythera Biopharmaceutical, is a formulation of synthetically derived deoxycholic acid, which targets and destroys localized fat under the chin. The injectable drug won unanimous recommendation for FDA approval from a panel of experts.
- Assuming that Kythera is approved by its PDUFA data, May 13, it will represent a breakthrough for removing targeted fat deposits. Currently, the main treatment options for extra fat under the chin is liposuction. The drug's likely approval may also make the company ripe for a buyout.
- Approval is widely anticipated, as the FDA generally accepts independent panel recommendations. ATX-101 is also being reviewed by regulatory authorities in Canada and Switzerland.
According to the American Society for Dermatologic Surgery, liposuction below the chin (also known as submental liposuction) costs between $2,700 and $5,175. Kythera has not publicly committed to a pricing range yet, but analysts are predicting annual revenues in the $300,00 to $500,000 range. This is not bad for a start-up that went public in 2012 and has seen its stock triple in price since its IPO.
While it is possible that the company will remain independent, Kythera may also represent an attractive takeover target for companies that focus on cosmetic and dermatologic products, such as Galderma and Allergan. The stock, which has a 52-week high of $56.00, closed at $45.19 yesterday after closing at $53.13 last Friday.