Opko Health - OPK STOCK NEWS

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.

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.

OPKO Health reports business highlights and financial results for Q2 2021. BioReference Laboratories test volume increased 32% compared to Q2 2020. BRL processed 2.8 million COVID-19 PCR tests and has capacity for over 100,000 tests per day. BRL performed 132,000 COVID-19 serology tests. OPKO entered into agreements with Nicoya Therapeutics and CAMP4 Therapeutics. OPKO sold a facility in Ireland for $65 million. Diagnostics revenue increased to $397.2 million. Pharmaceuticals revenue was $35.7 million. Consolidated total revenues were $442.4 million. Net loss for Q2 2021 was $16.2 million.