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 email@example.com
(END) Dow Jones Newswires