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.
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.
OPKO Health, Inc. (NASDAQ: OPK) has established a joint venture with LeaderMed Health Group to develop two clinical-stage drug products for the Asian market. The venture will focus on OPK88003, targeting obesity and diabetes, and Factor VIIa-CTP for hemophilia. OPKO retains a 47% stake in the venture after receiving a $1 million upfront payment and reimbursement for clinical trial materials. LeaderMed will manage funding, contributing $11 million for a 53% interest. This collaboration aims to enhance OPKO's market presence in Greater China and other Asian territories.
OPKO Health, Inc. (NASDAQ: OPK) has completed enrollment for the Phase 2 trial of RAYALDEE® for treating mild-to-moderate COVID-19, exceeding the expected total with 171 participants. The randomized study will assess RAYALDEE's efficacy in raising serum 25-hydroxyvitamin D levels and the resolution time of COVID-19 symptoms. Primary endpoints include achieving the targeted vitamin D levels, while secondary endpoints focus on hospitalization rates and overall illness severity. Topline results are anticipated later this year.
OPKO Health, Inc. (NASDAQ: OPK) has announced participation in two significant virtual investor conferences in September 2021. The 14th Annual Barrington Research Fall Conference will take place on September 9, 2021, featuring one-on-one and small-group meetings with management. Subsequently, OPKO will attend the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021, where management will engage in a fireside chat and additional investor meetings. A recording of the fireside chat will be available on OPKO's website starting September 13.
Rite Aid (NYSE: RAD) and BioReference, an OPKO Health company (NASDAQ: OPK), will provide free COVID-19 testing for New York State public school students ahead of the 2021-2022 school year. This ‘Back to School’ program allows students aged 4-17 to access RT-PCR tests at 115 Rite Aid drive-thru locations. Testing is voluntary, with results delivered digitally to parents. Governor Kathy Hochul emphasized the program's importance in combating the Delta variant and ensuring safe school environments. The initiative aligns with federal efforts to expand school testing.
BioReference Laboratories, part of OPKO Health (NASDAQ:OPK), has acquired the U.S. Ariosa centralized laboratory prenatal testing business from Roche. This acquisition enhances BioReference's non-invasive prenatal screening (NIPS) capabilities, particularly through the Harmony Prenatal Test, which is widely used and has been performed on over 1.5 million patients. The transaction aligns with BioReference's 40-year commitment to women's health and aims to improve prenatal testing accessibility, impacting millions of pregnancies annually.
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OPKO Health, Inc. (NASDAQ: OPK) will report its Q2 2021 operating and financial results on July 29, 2021, after U.S. market close. The company will provide a detailed business update during a conference call at 4:30 PM ET on the same day. Interested parties can pre-register for the call or access it via the provided webcast link. OPKO focuses on biopharmaceuticals and diagnostics, aiming to lead in rapidly growing markets through innovative technologies. Additional details and a replay will be available on OPKO's website.
OPKO Health, Inc. (NASDAQ: OPK) has entered into a worldwide agreement with CAMP4 Therapeutics for developing therapeutics based on the AntagoNAT technology. This agreement marks a significant step in advancing OPKO's lead compound for Dravet syndrome into clinical trials. OPKO will receive an upfront payment and is eligible for up to $93.5 million in milestone payments, plus royalties on product sales. The collaboration not only enhances OPKO’s focus on drug development but also validates its proprietary technology.