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.
OPKO Health, Inc. (NASDAQ: OPK) announced that Pfizer Japan submitted a New Drug Application for somatrogon, a long-acting recombinant human growth hormone intended for pediatric growth hormone deficiency treatment. This submission is based on Phase 3 studies showing somatrogon is as effective as GENOTROPIN (somatropin) in annual height velocity with comparable safety profiles. OPKO is responsible for the clinical program, while Pfizer handles registration and commercialization.
GeneDx, a subsidiary of OPKO Health (NASDAQ:OPK), has launched new genetic tests, including repeat expansion analysis for spinocerebellar ataxia (SCA) and Friedreich ataxia. These tests aim to address the diagnostic challenges associated with hereditary ataxias, which often have genetic underpinnings. With a comprehensive offering, GeneDx enhances access to testing, overcoming the limitations of existing diagnostic laboratories. The expansion reflects the company's commitment to rare diseases and aims to provide more options for patients, thereby facilitating precise medical management.
BioReference Laboratories, a subsidiary of OPKO Health, has signed agreements to provide COVID-19 testing for officials, players, and staff during the 2020-2021 seasons of the NBA and NHL. This includes PCR and rapid diagnostics across 30 NBA facilities in 28 U.S. cities. Additionally, BioReference supports U.S. Soccer's national teams and the Winter X Games. Executive Chairman Jon R. Cohen emphasized the company’s dedication to developing customized testing solutions. BioReference operates 11 lab locations and has a strong position in various healthcare segments, backing its testing services with a team of over 120 professionals.
BioReference Laboratories, part of OPKO Health (NASDAQ:OPK), has launched Scarlet Health, a digital platform for at-home diagnostic services. This innovative service allows patients to schedule specimen collection at their preferred locations, enhancing convenience and efficiency. Scarlet leverages BioReference's nationwide infrastructure, offering a secure and user-friendly experience for both patients and healthcare providers. As telemedicine investment surged to $1.6 billion in the past year, Scarlet aims to bridge the gap between traditional healthcare and modern telehealth services.
OPKO Health (NASDAQ: OPK) will participate in the virtual 39th Annual J.P. Morgan Healthcare Conference from January 11-14, 2021. Management plans to host one-on-one meetings with investors and will present on January 13 at 3:40 p.m. Eastern time. The presentation will be available for live streaming and later replay in the Investors section of OPKO's website. This conference allows OPKO to showcase its strategies and innovations in the biopharmaceutical and diagnostics sectors.
BioReference Laboratories, part of OPKO Health (NASDAQ: OPK), announced COVID-19 PCR test results for New York City's public schools, revealing a positivity rate of 0.47%. Testing began on September 2, 2020, with over 209,790 individuals tested across 1,200 schools, achieving an average turnaround time of 38 hours. The positivity rates varied by borough, with the Bronx having the highest at 0.71%. This initiative aims to ensure safe learning environments for students and staff amidst the pandemic.
Pfizer (PFE) and OPKO Health (OPK) announced that the FDA has accepted the filing of the Biologics License Application (BLA) for somatrogon, a long-acting growth hormone for treating pediatric growth hormone deficiency (GHD). The FDA's target decision date is in October 2021. Results from a Phase 3 trial demonstrated somatrogon met primary endpoints, showing higher annual height velocity compared to daily somatropin. The therapy offers potential benefits by reducing the need for daily injections. Somatrogon has received Orphan Drug designation in the U.S. and EU.
The Buffalo Bills, 2020 AFC East Division Champions, in partnership with BioReference Laboratories, an OPKO Health company (NASDAQ:OPK), announced a fan testing initiative for their upcoming AFC Divisional Wild Card playoff game. Fans must obtain a negative COVID-19 PCR test result within 72 hours to attend. The test scheduling will be facilitated through a URL provided to ticket purchasers. This initiative aims to ensure a safe environment and marks an innovative step in safely welcoming fans back to live sporting events.
OPKO Health, Inc. (NASDAQ: OPK) announced the appointment of Roger Medel, M.D. as an independent Board member effective December 18, 2020. With this addition, the Board now consists of 11 Directors, including seven independents. Dr. Medel, co-founder of MEDNAX, Inc., brings extensive experience in healthcare services, having led MEDNAX's growth to serve 25% of sick and premature infants in the U.S. His insights are expected to enhance OPKO’s strategic execution, as stated by Chairman Dr. Phillip Frost.
OPKO Health (NASDAQ: OPK) announced participation in three virtual investor conferences. Key events include the H.C. Wainwright 6th Annual Israel Virtual Conference on November 12, 2020, featuring a fireside chat at 9:00 a.m. ET. At the Jefferies 2020 Virtual London Healthcare Conference from November 17-19, OPKO will present on November 18 at 10:15 a.m. ET, with webcasts available afterward. Lastly, the Piper Sandler 32nd Annual Virtual Healthcare Conference will take place from December 1-3, 2020, also featuring a fireside chat and one-on-one meetings.