Biotech Values

[DewDiligence]

FDA approves KYTH’s Kybella (f/k/a ATX-101) for submental (“double chin”) fat:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm444978.htm

Kybella is identical to the deoxycholic acid that is produced in the body. Deoxycholic acid produced in the body helps the body absorb fats. Kybella is a cytolytic drug, which when injected into tissue physically destroys the cell membrane. When properly injected into submental fat, the drug destroys fat cells; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin.

…Kybella can cause serious side effects, including nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing. The most common side effects of Kybella include swelling, bruising, pain, numbness, redness and areas of hardness in the treatment area.

In other words (as with Botox and dermal fillers), Kybella should be injected only by someone who has experience with the procedure!

KYTH closed down 4% today; evidently, FDA approval on the first review cycle was already baked into the valuation.