OPKO HEALTH, INC.

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OPKO Health Shares Drop 20% After Complete Response Letter for Somatrogon

01/24/2022 | 10:21am EDT

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

01-24-22 1021ET

Stocks mentioned in the article
ChangeLast1st jan.
OPKO HEALTH, INC. -0.83% 2.97 Delayed Quote.-37.53%
PFIZER, INC. 1.43% 50.67 Delayed Quote.-14.25%
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05/09OPKO Health Reports 2022 First Quarter Business Highlights and Financial Results
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Analyst Recommendations on OPKO HEALTH, INC.
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Financials (USD)
Sales 2022 1 127 M - -
Net income 2022 -168 M - -
Net Debt 2022 - - -
P/E ratio 2022 -12,8x
Yield 2022 -
Capitalization 2 065 M 2 065 M -
Capi. / Sales 2022 1,83x
Capi. / Sales 2023 1,86x
Nbr of Employees 5 767
Free-Float 59,9%
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Technical analysis trends OPKO HEALTH, INC.
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Mean consensus BUY
Number of Analysts 5
Last Close Price 3,03 $
Average target price 6,50 $
Spread / Average Target 115%
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Managers and Directors
Phillip Frost Chairman & Chief Executive Officer
Jon Roger Cohen Director & Senior Vice President
Adam E. Logal CFO, Treasurer, Chief Accounting Officer & SVP
Jane H. Hsaio Vice Chairman & Chief Technical Officer
Steven D. Rubin Director & Executive Vice President-Administration
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