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OPKO HEALTH, INC.

(OPK)
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OPKO Health, Inc. Completes Enrollment in Phase 2 Trial Evaluating Rayaldee as Treatment for Symptomatic Covid-19 Outpatients

08/30/2021 | 04:17pm EDT

OPKO Health, Inc. 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. The REsCue trial randomized symptomatic COVID-19 outpatients in a 1:1 ratio to 4 weeks of treatment with RAYALDEE or placebo and a 2-week follow-up. Dosing with RAYALDEE begins with 300 mcg per day on Days 1, 2 and 3 followed by 60 mcg per day on Days 4 through 27. This dosing regimen is modelled to raise serum total 25-hydroxyvitamin D (25D) within the range of 50-100 ng/mL. The trial’s primary efficacy endpoints are attainment of the targeted 25D level and time to resolution of COVID-19 symptoms. Secondary endpoints include incidence of emergency room or urgent care visits, oxygen saturation below 94%, need for and duration of hospitalization, requirement for mechanical ventilation, mortality rate and severity and duration of illness evidenced by quality-of-life and biochemical measures.


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Financials (USD)
Sales 2021 1 576 M - -
Net income 2021 -10,9 M - -
Net Debt 2021 - - -
P/E ratio 2021 -205x
Yield 2021 -
Capitalization 2 513 M 2 513 M -
Capi. / Sales 2021 1,59x
Capi. / Sales 2022 2,12x
Nbr of Employees 5 269
Free-Float 59,5%
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Mean consensus BUY
Number of Analysts 5
Last Close Price 3,69 $
Average target price 6,60 $
Spread / Average Target 78,9%
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Managers and Directors
Phillip Frost Chairman & Chief Executive Officer
Jon Roger Cohen Director & Senior Vice President
Adam E. Logal CFO, Treasurer, Chief Accounting Officer & SVP
Jane H. Hsaio Vice Chairman & Chief Technical Officer
Steven D. Rubin Director & Executive Vice President-Administration
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