OPKO Health, Inc. (OPK) is an innovative global biopharmaceutical firm engaged in the discovery, development, and commercialization of medicines related to diseases such as molecular diagnostics, women’s health, esoteric testing, and anatomical testing. One of the lead product candidates of the company is Rayaldee used for treating secondary hyperparathyroidism in kidney patients.
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The price of OPK stock during the regular trading on January 21, 2022, was $4.24 with a decline of 2.75%. At last check in the aftermarket, the stock further dropped by 11.56%.
OPK: Events and Happenings
On January 21, 2022, OPK and Pfizer co-announced about the issuance of a complete response letter for biologics licensing application by the FDA for an investigational growth hormone somatrogon or NGENLA. It is used for treating growth hormone deficiency in pediatric patients. Pfizer is assessing the FDA’s observations and will determine the next important possible steps to take.
On January 20, 2022, OPK and Pfizer Japan co-reported about the approval of somatrogon injection by the Japanese Ministry of Health, Labor and Welfare. The approval is the result of Phase 3 trials in Japanese subjects with pediatric GHD, and a comparison of the efficacy and safety of NGENLA with GENOTROPIN.
On January 18, 2022, OPK co-reported with Sema4 about their entry into a definitive contract for the acquisition of the company’s wholly-owned subsidiary, GeneDx, Inc. by Sema4. On January 5, 2022, OPK reported that the company’s Executives presented at the Virtual 40th Annual J.P. Morgan Healthcare Conference held on January 10-13, 2022.
On December 23, 2021, OPK reported initial topline data from the Phase 2 clinical trial of RAYALDEE for treating COVID-19. This study is aligned with a growing medical indication that vitamin D repletion therapy can quicken the recovery from COVID-19. On December 08, 2021, OPK reported about the approval of its 4Kscore Test by the FDA. The test provides data to evaluate the occurrence of prostate cancer before a prostate biopsy decision.
On November 29, 2021, OPK reported about the preparedness of testing for the Omicron Variant of COVID-19. The testing is based on the recognition of specified RNA target genes common in all coronaviruses. On November 29, 2021, OPK reported that the company’s Executives presented at the Virtual 33rd Annual Piper Sandler Healthcare Conference held on November 30-December 2, 2021.
OPK: Key Financials
On October 25, 2021, OPK reported its financial results for the three months ended September 30, 2021. Some of the key updates are as follows.
Revenue and Assets
Total revenue in Q3 2021 was $0.38 million compared to the prior year period when it was $0.42 million. Total current assets in Q3 2021 were $0.55 million.
Basic and diluted net income in Q3 2021 was $0.028 million or $0.04 per share compared to the same period of 2020 when it was $0.023 million or $0.04 per share.
OPK stock is 18% up the past half-year period despite the challenges faced by the economy. The company’s stock dipped in the aftermarket after the company announced the submission of a biologics license application for its investigational hormone with Pfizer. The analysts are suggesting that the company should invest in pipeline projects at a faster pace for quicker results.