Earlier in the month of November, Opko Health Inc. (NASDAQ:OPK) posted financial report for the quarter closed September 30, 2018. The results clearly indicated that the company is gradually moving back to the growth track.
As per the fiscal report, net loss for the quarter closed September 30, 2018 came at $27.7 million, a drop of 23% as compared to the same quarter of 2017. Total revenues came at $249.8 million versus revenue of $246 million for the same period of 2017.
Opko reported that revenue from products during the reported period comprised $5.8 million from RAYALDEE while revenues from services stood at $202.8 million. RAYALDEE total prescriptions posted by IMS surged 222% for Q3 2018 as compared to the same quarter in 2017. As per the data reported on November 1, 2018, around 79% of patients are eligible for RAYALDEE under their insurance programs.
Opko commenced the Phase 2 clinical study to assess the efficacy and safety of RAYALDEE as a new treatment for SHPT in adults having insufficiency of vitamin D and stage 5 CKD requiring hemodialysis. This study will be conducted at several dialysis centers in the United States in two sequential cohorts. As per the update, the first cohort of around 44 subjects will be cured in a randomized, open-label way for 26 weeks with either placebo or RAYALDEE to know the appropriate dosing to be assessed in the second cohort.
Premarket Approval request for Claros® point-of-care PSA assessment under review by FDA; decision expected in the first half of next year. OPKO Health has completed a PMA application to FDA for Sangia, the company’s point of care PSA test using the Claros I immunoassay analyzer. As per the release, this marks as the first test on company’s proprietary diagnostic platform with a potential to offer fast, quantitative blood test report in the physician’s office with just a little whole blood.
Earlier in the month of September, Opko stock was suspended for a while from the NASDAQ Stock Market platform. However, this suspension was then removed on September 14, 2018.