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.
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.
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.