What happened
Shares of Opko Health (OPK 3.28%) were crashing 32.3% lower this week as of the market close on Thursday, based on data from S&P Global Market Intelligence. The steep decline came after Opko and its partner, Pfizer (PFE 0.55%), announced after the market close on Jan. 21, 2022 that the U.S. Food and Drug Administration (FAD) issued a Complete Response Letter (CRL) for the Regulatory Filing for approval of human growth hormone somatrogon.
So what
The FDA's decision was surprising considering that the human growth hormone has already received approvals in several other countries. Regulators in Australia and Canada approved the product in 2021. Japanese regulators approved somatrogon last week.
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Neither Opko Health nor Pfizer revealed the specific reason given by the FDA for rejecting somatrogon. The agency's rationale for refusing approval will be important in how Pfizer moves forward. The big drugmaker is responsible for guiding somatrogon through regulatory approval processes and commercializing the product once approved.
Now what
Opko could still have some good news on the way that could provide a catalyst for the biotech stock. An approval decision from the European Commission for somatrogon is expected early this year. In December, the European Medicines Agency's Committee for Medicinal Products for Human Use gave a positive opinion recommending authorization of somatrogon.
What about the next steps in the U.S.? Brenda Cooperstone, Pfizer's chief development officer for rare diseases, stated, "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."
