KYTHERA submental fat drug candidate meets all primary endpoints in Ph III

17 September 2013

US biotech firm KYTHERA Biopharmaceuticals (Nasdaq: KYTH) saw its stock upgraded to $50 a share from $34 by Leerink analysts and an outperform rating and $50 target by Cowen analysts, after the company said that its ATX-101 REFINE-1 and REFINE-2 Phase III trials met all primary and secondary endpoints. The shares rose 29% to $43.24 in pre-market trading today (September 17).

These two pivotal Phase III trials were conducted in the USA and Canada to compare the efficacy and safety of a 2mg/cm2 dose of ATX-101 versus placebo for the reduction of submental fat, which commonly presents as a double chin.

ATX-101 is a proprietary formulation of a purified synthetic version of deoxycholic acid, a naturally occurring molecule in the body that aids in the breakdown of dietary fat. If approved, it will be a first-in-class submental contouring injectable drug.

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