Pfizer - OPKO Health's Growth Hormone Deficiency Candidate Receives FDA Response Letter

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