KYTHERA Biopharmaceuticals, Inc.
) 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
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
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
) with a Zacks Rank #1 (Strong Buy), and
Alexion Pharmaceuticals, Inc.
) with a Zacks Rank #2 (Buy).
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