Unanimous FDA advisory panel backing for KYTHERA’s ATX-101
US biotech firm KYTHERA Biopharmaceuticals (Nasdaq: KYTH) said yesterday that the US Food and Drug Administration's Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to support the approval of ATX-101 (deoxycholic acid) injection.
The recommendation is for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults, which is often referred to as a double chin. If approved, ATX-101 would be a first-in-class submental contouring injectable drug.
Trading in KYTHERA stock was halted Monday ahead of the Committee deliberations, but the shares, which had soared 28% the previous week following positive briefing documents on ATX-101 by FDA staffers, closed the day down 3.7% at $51.17.
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