The FDA has issued a Complete Response Letter (CRL) to Pfizer Inc (NYSE: PFE) and OPKO Health Inc's (NASDAQ: OPK) somatrogon.

• Somatrogon is an investigational once-weekly long-acting recombinant human growth hormone for pediatric growth hormone deficiency (GHD).

• Pfizer is evaluating the FDA's comments.

• Earlier this week, Japan's Ministry of Health, Labour, and Welfare approved Ngenla (somatrogon) Injection 24 mg Pens and 60mg Pens for the long-term treatment of GHD pediatric patients.

• In 2021, Health Canada approved Ngenla, and in December 2021, the Committee for Medicinal Products for Human Use (CHMP) of EMA issued a positive opinion recommending approval of somatrogon.

• Related content: Benzinga's Full FDA Calendar.

• The European Commission (EC) decision is expected in early 2022.

• In 2014, Pfizer and OPKO entered into a worldwide agreement to develop and commercial 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.

• Price Action: PFE shares are down 3.77% at $50.80, and OPK stock is down 12.50% at $3.71 during the premarket session on Monday's last check.

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