New Clinical Data on OPKO Health™s RAYALDEE® (ER Calcifediol) Presented at Kidney Week 2023
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...
MIAMI, Feb. 03, 2022 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) announces that Vifor Fresenius Medical Care Renal Pharma (VFMCRP) has initiated the commercial launch of RAYALDEE® (extended release calcifediol) in Germany, the first launch of RAYALDEE outside the U.S. VFMCRP is OPKO’s commercial partner for RAYALDEE in Europe and selected markets outside the U.S., and the sales kick-off in Germany began with presentations by VFMCRP executives and several nephrology key opinion leaders.
OPKO Health announced preliminary topline results from its Phase 2 trial with Rayaldee to treat mild-to-moderate COVID-19. Preliminary data indicate that improving vitamin D status with oral Rayaldee results in earlier resolution of respiratory symptoms associated with COVID-19. Following oral administration, Rayaldee gradually releases calcifediol, the natural storage form of vitamin D3, to safely and reliably raise a patient’s serum total 25-hydroxyvitamin D (25D) well above current targets of 20 or 30 ng/mL.
OPKO Health announced the completion of enrollment in its phase 2 trial with Rayaldee as a treatment for mild-to-moderate Covid-19. The US trial, “A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of Rayaldee (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue),” was expected to enroll approximately 160 subjects, including some with stage 3 or 4 chronic kidney disease (CKD) who is at higher risk for developing more severe illness. Final enrollment reached 171 subjects and topline data are expected later this year.
MIAMI, Aug. 30, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) announces the completion of enrollment in its Phase 2 trial with RAYALDEE® as a treatment for mild-to-moderate COVID-19. The U.S. trial, “A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue),” was expected to enroll approximately 160 subjects, including some with stage 3 or 4 chronic kidney disease (CKD) who are at higher risk for developing more severe illness. Final enrollment reached 171 subjects and topline data are expected later this year.
MIAMI, Sept. 15, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) announces the initiation of a Phase 2 trial with RAYALDEE® as a treatment for mild-to-moderate COVID-19. The trial, “A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue),” is expected to enroll approximately 160 subjects, many with stage 3 or 4 chronic kidney disease (CKD) who are at higher risk for developing more severe illness.
OPKO Health, Inc. (NASDAQ: OPK) today announced that the U.S. Food and Drug Administration (FDA) has authorized OPKO to undertake a Phase 2 trial with RAYALDEE® as a treatment for patients with mild-to-moderate COVID-19. The trial, entitled “A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue),” is estimated to enroll 166 subjects, including many with stage 3 or 4 chronic kidney disease (CKD).
OPKO Health, announced that the US Food and Drug Administration (FDA) has authorized OPKO to undertake a phase 2 trial with Rayaldee as a treatment for patients with mild-to-moderate COVID-19. The trial, entitled “A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of Rayaldee (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue),” is estimated to enroll 166 subjects, including many with stage 3 or 4 chronic kidney disease (CKD).
MIAMI, June 01, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) today announced that the U.S. Food and Drug Administration (FDA) has authorized OPKO to undertake a Phase 2 trial with RAYALDEE® as a treatment for patients with mild-to-moderate COVID-19. The trial, entitled “A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue),” is estimated to enroll 166 subjects, including many with stage 3 or 4 chronic kidney disease (CKD).