2023 Press/Media Releases:

OPKO Health to Present New Clinical Data on Rayaldee (ER Calcifediol) at Kidney Week 2023

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MIAMI, Oct. 25, 2023 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) will present late-breaking clinical data on RAYALDEE® extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia on Thursday, November 2, 2023. These data will be presented in a poster, “Control of Secondary Hyperparathyroidism with Extended-release Calcifediol is Associated with Slower CKD Progression” (#TH-PO1152) at 10:00 a.m. Eastern time in Exhibit Halls B-D by authors Charles W. Bishop Ph.D., Stephen A. Strugnell Ph.D. and Akhtar Ashfaq, M.D., FACP, FASN.

OPKO Health will present two other posters at ASN Kidney Week summarizing additional new clinical data on RAYALDEE. One poster, “Extended-release Calcifediol Overcomes Impact of Low eGFR on Vitamin D Metabolism” (#FR-PO319), will be presented in the “Bone and Mineral Metabolism: Basic” session at 10:00 a.m. Eastern time on Friday, November 3, 2023, in Exhibit Halls B-D. The data demonstrate that RAYALDEE effectively and reliably raises serum levels of 25-hydroxyvitamin D (25D) and 1,25-dihydroxyvitamin D in non- dialysis patients with secondary hyperparathyroidism (SHPT), making it an attractive alternative to vitamin D hormone therapies (i.e., calcitriol, paricalcitol and doxercalciferol)

 The other poster, “Extended-Release Calcifediol: A Data Journey from Phase 3 Studies to Real-World Evidence Highlights the Importance of Early Treatment of Secondary Hyperparathyroidism” (#FR-PO972), will be presented in the “CKD Interventions: Trials and Quality Improvement” session at 10:00 a.m. Eastern time on Friday, November 3, 2023 in Exhibit Halls B-D. The data demonstrate that effective control of SHPT has been achieved with RAYALDEE treatment in both randomized clinical trials and in a real-world clinical experience trial. Data from these trials support early initiation of SHPT treatment with RAYALDEE in order to delay disease progression. 


RAYALDEE is an extended-release (ER) oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3. The product is the first and only medicine approved by the U.S. Food and Drug Administration for raising serum total 25D and lowering blood levels of intact parathyroid hormone (iPTH). RAYALDEE is approved to treat SHPT in adults with stage 3 or 4 CKD and vitamin D insufficiency in the U.S. and in 11 European countries. Slowing CKD progression with RAYALDEE treatment is not currently an approved indication.

About OPKO Health, Inc. 

OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies.

LHA Investor Relations
Yvonne Briggs
Bruce Voss


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