KYTHERA Proposes Public Offering - Analyst Blog

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KYTHERA Biopharmaceuticals, Inc. ( KYTH ) announced that it has initiated a public offering of its common stock worth $100 million.

The company intends to use the funds for further development and commercialization of its candidate, ATX-101, which is being evaluated for the reduction of submental fat. The remaing funds will be used for general corporate purposes and working capital requirements. Upon approval, ATX-101 will enjoy the status of being the first-in-class submental contouring injectable drug.

We believe that the utilization of funds for further development and commercialization of ATX-101, the lead candidate at KYTHERA, is a prudent move by the company. Last month, KYTHERA reported encouraging top line data from two phase III pivotal studies on ATX-101.

The pivotal studies, REFINE-1 (Study ATX-101-11-22) and REFINE-2 (Study ATX-101-11-23), were conducted in the U.S. and Canada. All primary as well as secondary endpoints were met. The studies evaluated the efficacy and safety of ATX-101 (2 mg/cm2) versus placebo in reducing submental fat.

The REFINE-1 study result showed that while 70.3% patients on ATX-101 (versus 18.7% in the placebo arm) showed an improvement of at least one grade, 13.4% patients on ATX-101 (versus 0% in the placebo arm) improved two grades from the baseline.

Results from the REFINE-2 study showed that while 66.9% patients on ATX-101 (versus 22.4% in the placebo arm) showed an improvement of at least one grade, 18.7% patients on ATX-101 (versus 3.2% in the placebo arm) improved two grades from the baseline.

The studies also achieved secondary endpoints which included reduction in volume of the submental region as measured by magnetic resonance imaging (MRI), and improvement in visual and psychological impacts of submental fat, assessed using the Patient-Reported Submental Fat Impact Scale. The candidate was found to be safe with no treatment-related serious adverse events observed during the studies.

Kythera currently carries a Zacks Rank #3 (Hold). Currently, companies which look attractive include Actelion Ltd. ( ALIOF ) with a Zacks Rank #1 (Strong Buy), and Cempra, Inc. ( CEMP ) and Alexion Pharmaceuticals, Inc. ( ALXN ) with a Zacks Rank #2 (Buy).



ACTELION LTD (ALIOF): Get Free Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: ALIOF , ALXN , CEMP , KYTH

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