OPKO dives as FDA issues CRL on somatrogon BLA

24 January 2022

The US Food and Drug Administration has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for somatrogon, which is under development by US pharma giant Pfizer (NYSE: PFE) and OPKO Health (Nasdaq: OPK).

OPKO shares fell 11.5% to $3.75 in after-hours trading, while Pfizer dipped 2.3% by Friday’s close following the announcement.

Pfizer said it is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward.

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