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$OPK Pfizer, OPKO Health's somatrogon application validated in Europe
Feb. 26, 2021 8:38 AM ETPfizer Inc. (PFE)By: Mamta Mayani, SA News Editor8 Comments
The European Medicines Agency has validated for review Pfizer (NYSE:PFE) and OPKO Health's (NASDAQ:OPK) marketing authorization application (MAA) for somatrogon, a long-acting recombinant human growth hormone for the treatment of pediatric patients with growth hormone deficiency (GHD).
European Commission decision is expected in 2022.
The submission is supported by the results of a Phase 3 trial evaluating the safety and efficacy of somatrogon administered once-weekly to pediatric patients with GHD.
In 2014, Pfizer and OPKO inked agreement for the development of somatrogon for the treatment of GHD.
Recently in January, the FDA accepted for filing the initial BLA for somatrogon with a target PDUFA action date of October 2021.
OPK shares up 5% premarket.
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https://seekingalpha.com/news/3667118-pfizer-opko-healths-somatrogon-application-validated-in-europe?utm_source=advfn.com&utm_medium=referral