On January 21, OPKO Health Inc. (OPK) and Pfizer Inc. announced receiving a Complete Response Letter for somatrogon’s Biologics License Application. Consequently, OPK stock suffered a blow in the after-hours.
During regular trading, the stock lost 2.75% at its closing price of $4.24 on Friday. Following the announcement, the stock plunged further to reach $3.75 in the after-hours. Hence, OPK lost a further 11.56% at an after-hours volume of 639K shares.
The biopharmaceutical and diagnostics company, OPKO Health Inc. has a market capitalization of $2.89 billion. Currently, the company has 681.34 million shares outstanding in the market.
Somatrogon
Somatrogon is an investigational recombinant human growth hormone for the treatment of GHD (growth hormone deficiency) in pediatric patients. GHD is a rare disease in which the pituitary gland secretes an inadequate amount of the growth hormone. Thus causing a delay in puberty, restricted growth, and many other physical and associated mental problems as well.
Previously, in 2014, OPK and Pfizer had entered into a worldwide agreement for developing and commercializing somatrogon for GHD. According to the agreement, clinical development is OPK’s responsibility while registration and commercialization are Pfizer’s.
Recent Developments Regarding Somatrogon
Pfizer has submitted regulatory applications for somatrogon to several countries around the world for review. Recently, NGENLA® (somatrogon) inj. Was approved by Japan’s Ministry of Health, Labor, and Welfare for treatment of growth failure in pediatric patients due to growth hormone. Moreover, in 2021, NGENLA® was also approved by Health Canada and Australia’s Therapeutic Goods Administration. Furthermore, a decision from European Commission is expected soon, based on EMA’s CHMP’s recent positive opinion.
CRL regarding Somatrogon
As per Friday’s announcement, FDA has issued a CRL for somatrogon’s Biologics License Application BLA). Currently, Pfizer is assessing the comments of the FDA and plans to work with the agency for the best course forward.
OPK’s Recent Participation
Recently, OPK participated in the 40th Annual J.P. Morgan Healthcare Conference which took place from January 10 to 13, 2022. Further, the company’s management hosted a one-on-one meeting with investors along with a fireside chat on January 12, at the conference.
OPK’s Financial Data
On October 28, the company declared its financial results for the third quarter of 2021.
In the third quarter of 2021, consolidated total revenues reported were $385.8 million against $428.1 million in Q3 of 2020.
Additionally, OPK ended the quarter with cash, cash equivalents, and marketable securities of $148.6 million.
