OPKO Health Tanks 10% After FDA Issues Complete Response Letter For Somatrogon

(RTTNews) - Shares of OPKO Health, Inc. (OPK) slipped nearly 10% in after-hours trading on Friday after the U.S. Food and Drug Administration issued a Complete Response Letter for the Biologics License Application for somatrogon.

Somatrogon is an investigational once-weekly long-acting recombinant human growth hormone for the treatment of growth hormone deficiency (GHD) in pediatric patients. Pfizer is evaluating the FDA's comments and will work with the agency to determine an appropriate path forward.

"We remain confident in the potential treatment benefits that somatrogon has to offer patients around the world," said Brenda Cooperstone, MD, Chief Development Officer, Rare Disease, Pfizer Global Product Development. "We will work closely with the FDA to determine the best path forward to bring this important once-weekly treatment option to pediatric growth hormone deficiency patients and their families."

Regulatory applications for somatrogon have been submitted to several countries around the world for review. Earlier this week, Japan's Ministry of Health, Labour and Welfare approved NGENLA (somatrogon) Inj. 24 mg Pens and 60mg Pens, for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.

OPK closed Friday's trading at $4.24, down $0.12 or 2.75%, on the Nasdaq. The stock further slipped $0.40 or 9.43% in the after-hours trading.