Opko Health Inc. - OPK STOCK NEWS

OPKO Health, Inc. (NASDAQ: OPK) announced FDA approval of its 4Kscore Test for men 45 and older with abnormal PSA levels or DRE results. This test assesses aggressive prostate cancer risk prior to biopsy. The 4Kscore Test has been used in over 300,000 assessments since 2014 and is incorporated in major cancer guidelines. Developed using data from over 30,000 samples, it provides a numerical score based on PSA biomarkers and other patient information, aiming to improve diagnostic accuracy in prostate cancer.

OPKO Health, Inc. (NASDAQ: OPK) announced the passing of Director Richard A. Lerner, M.D., on December 2, 2021, at the age of 83. Dr. Lerner served on the Board since 2007, contributing significantly to the company and the scientific community. He was an esteemed leader at The Scripps Research Institute, enhancing its stature in biomedical research. His accolades include multiple prestigious awards and numerous patents. OPKO’s management expressed deep condolences and recognized Dr. Lerner’s invaluable contributions, marking a significant loss for the company and the industry.

BioReference Laboratories, part of OPKO Health (NASDAQ: OPK), announced its preparedness for COVID-19 testing in light of the Omicron variant. Their PCR tests remain effective, targeting RNA genes that are consistent across all coronavirus variants. Despite changes in the Spike protein associated with the Omicron variant, BioReference confirms that diagnosis capabilities remain intact, with over 19 million PCR tests conducted. The company operates four lab facilities and over 200 rapid testing sites nationwide, emphasizing a commitment to maintain and potentially increase testing capacity as needed.

OPKO Health, Inc. (NASDAQ: OPK) will participate in the Piper Sandler 33rd Annual Virtual Healthcare Conference from November 30 to December 2, 2021. The company will provide a pre-recorded fireside chat accessible to registered attendees. On December 1, management will be available for one-on-one virtual meetings with investors, which can be arranged through Piper Sandler. OPKO aims to excel in large, rapidly growing markets through its biopharmaceutical and diagnostics expertise and proprietary technologies. For further details, visit www.opko.com.

OPKO Health reported its Q3 2021 results, highlighting a revenue drop to $385.8 million from $428.1 million in Q3 2020. Operating income surged 72% to $37.8 million.

Notably, NGENLA™ was approved in Canada for pediatric growth hormone deficiency, with global applications ongoing. BRL processed 2.2 million COVID-19 PCR tests but saw a decline in testing volume. RAYALDEE revenues rose to $8.5 million. Cash and equivalents totaled $148.6 million as of September 30, 2021.

OPKO Health, Inc. (NASDAQ: OPK) is set to release its financial results for Q3 2021 after market close on October 28, 2021. The conference call with senior management will begin at 4:30 PM ET on the same day, offering a detailed business update and financial guidance. Participants can pre-register for the call or listen via a live webcast. A replay of the call will be available on OPKO's website. The company focuses on establishing leading positions in biopharmaceuticals and diagnostics through innovative technologies.

Taysha Gene Therapies has launched a partnership with GeneDx to provide free genetic testing for Giant Axonal Neuropathy (GAN) to individuals at risk. This initiative aims to enhance disease awareness and improve diagnostic accessibility, addressing the estimated 2,400 patients with GAN in the US and Europe. The company's gene therapy, TSHA-120, has shown promising results in halting disease progression in clinical trials. Data from the high-dose cohort is expected in late 2021.

Pfizer and OPKO Health announced an extension of the FDA review period for somatrogon, a long-acting growth hormone treatment for pediatric growth hormone deficiency. The Prescription Drug User Fee Act (PDUFA) goal date is now set for January 2022, an extension of three months due to additional data submitted by Pfizer. Somatrogon has Orphan Drug designation in the U.S. and EU, aimed at addressing a rare disease affecting 1 in 4,000 to 10,000 children.

GeneDx, a leader in genomic analysis and a subsidiary of OPKO Health (NASDAQ:OPK), announced it has successfully completed clinical genetic exome sequencing for over 300,000 patients, the largest dataset globally. The company noted a 40% annual growth in exome sequencing demand, with nearly 100,000 completed in the past year. Their services yield a definitive diagnosis in 20% more cases, alongside fewer variants of unknown significance. GeneDx's tests are increasingly recommended as essential for diagnosing genetic disorders, particularly in neonatal care.