Welcome to our dedicated page for Opko Health news (Ticker: OPK), a resource for investors and traders seeking the latest updates and insights on Opko Health stock.
OPKO Health reports developments across a multinational biopharmaceutical and diagnostics business. Recurring updates cover operating results, financial guidance, BioReference laboratory testing services and digital access through BioReference Direct, and RAYALDEE commercialization through EirGen Pharma in Greater China.
The company also reports research collaborations and clinical development from ModeX Therapeutics, including its MSTAR multispecific antibody platform, MDX2301 for COVID-19 prevention, and MDX2003, a tetraspecific T-cell engager for B-cell lymphomas. News also includes pharmaceutical partnerships, diagnostic-service changes, investor presentations, and business updates tied to OPKO's pharmaceutical and diagnostics segments.
Saol Therapeutics has announced a collaboration with GeneDx to identify patients with Pyruvate Dehydrogenase Complex Deficiency (PDCD), a rare mitochondrial disease affecting fewer than 300 children annually in the U.S. The partnership aims to increase recruitment for a Phase 3 clinical trial testing dichloroacetate (DCA), which has Orphan Product designation from the FDA for congenital lactic acidosis. The trial is crucial as PDCD currently lacks FDA-approved treatments. Dr. Peter Stacpoole emphasizes the importance of the collaboration for effective patient recruitment.
OPKO Health, Inc. (NASDAQ: OPK) announced its fourth quarter 2021 financial results with total revenues of $401.3 million, down from $494.6 million in Q4 2020. The company reported a net loss of $73.8 million, or $0.11 per share, compared to net income of $32.3 million a year prior. Key highlights include NGENLA® receiving regulatory approvals in multiple countries and RAYALDEE® launched in Germany. OPKO has entered a definitive agreement for Sema4 to acquire GeneDx for a potential total consideration of $623 million.
OPKO Health, Inc. (NASDAQ: OPK) is set to release its financial results for the quarter ended December 31, 2021, post-market on February 24, 2022. The company will also provide a business update and financial guidance during a conference call at 4:30 p.m. Eastern on the same day. Investors can pre-register for the call or access it via a live audio webcast. The call aims to discuss operating metrics and future outlook. For more details about OPKO's strategies and market position, visit their website.
Pfizer Inc. (NYSE: PFE) and OPKO Health, Inc. (NASDAQ: OPK) received EU marketing authorization for NGENLA™ (somatrogon), a long-acting growth hormone replacement therapy for children with growth hormone deficiency (GHD). This innovative treatment reduces injection frequency from daily to weekly, potentially enhancing patient adherence and quality of life. The approval is based on the positive results from a Phase 3 study demonstrating NGENLA's non-inferiority to GENOTROPIN® (somatropin) in height velocity. NGENLA is now available across all EU states, Iceland, Norway, and Liechtenstein.
OPKO Health, Inc. (NASDAQ: OPK) announces the launch of RAYALDEE® in Germany, marking the first international release of the extended-release calcifediol product. Vifor Fresenius Medical Care Renal Pharma (VFMCRP), OPKO's partner, plans to expand the rollout across 11 European countries with Switzerland next in line. RAYALDEE is indicated for secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency, addressing a significant market opportunity in Europe, where about 26 million people are affected.
Pfizer Inc. (NYSE: PFE) and OPKO Health, Inc. (NASDAQ: OPK) received a Complete Response Letter (CRL) from the FDA concerning their Biologics License Application for somatrogon, a once-weekly treatment for pediatric growth hormone deficiency (GHD). Pfizer will collaborate with the FDA to address the feedback. Despite the setback, somatrogon has gained approvals in several countries, including Japan, Canada, and Australia. The European Commission decision is expected soon. The companies remain committed to advancing somatrogon and addressing unmet medical needs in GHD.
OPKO Health and Pfizer Japan announced the approval of NGENLA®, a once-weekly treatment for children with growth hormone deficiency (GHD), approved by Japan's Ministry of Health. This long-acting recombinant human growth hormone reduces injection frequency from daily to weekly, enhancing convenience for patients. The approval is based on positive outcomes from two Phase 3 clinical studies, showing comparable efficacy to GENOTROPIN. NGENLA® was well tolerated, marking a significant development in pediatric GHD treatment.
OPKO Health, Inc. (NASDAQ: OPK) announced its participation in the 40th Annual J.P. Morgan Healthcare Conference, scheduled for January 10-13, 2022. The company will engage in one-on-one meetings with investors and host a virtual fireside chat on January 12 at 3:00 p.m. ET. The chat will be webcast live, with a replay available on OPKO's website.
OPKO is a biopharmaceutical and diagnostics firm focused on leveraging its proprietary technologies for growth in rapidly expanding markets.
OPKO Health, Inc. (NASDAQ: OPK) announced preliminary results from its Phase 2 trial of RAYALDEE for mild-to-moderate COVID-19, indicating that enhanced vitamin D status can expedite the resolution of respiratory symptoms. The trial involved 171 symptomatic COVID-19 outpatients and observed a significant increase in serum 25D levels, reaching 82 ng/mL by Day 7. Patients treated with RAYALDEE also experienced a faster resolution of respiratory symptoms, with chest congestion resolving 3.4 days earlier compared to placebo. No significant safety concerns were noted during the study.
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.