OPKO Health Shares Drop 20% After Complete Response Letter for Somatrogon
24 Januar 2022 - 4:36PM
Dow Jones News
By Chris Wack
OPKO Health Inc. shares fell 20% to $3.41 after the Food and
Drug Administration declined to approve its treatment for children
with growth hormone deficiency that it developed with partner
Pfizer Inc.
On Friday, the FDA issued a Complete Response Letter for the
Biologics License Application for somatrogon, an investigational
once-weekly long-acting recombinant human growth hormone for the
treatment of growth hormone deficiency in pediatric patients.
Pfizer said it is evaluating the FDA's comments and will work
with the agency to determine an appropriate path forward.
Regulatory applications for somatrogon have been submitted to
several countries around the world for review. Japan last week
approved somatrogon injectable pens for the long-term treatment of
pediatric patients who have growth failure due to an inadequate
secretion of endogenous growth hormone.
In 2014, Pfizer and OPKO entered into a worldwide agreement for
the development and commercialization of somatrogon for the
treatment of GHD. Under the agreement, OPKO is responsible for
conducting the clinical program and Pfizer is responsible for
registering and commercializing the product for GHD.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 24, 2022 10:21 ET (15:21 GMT)
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