Entries by opkomanager

OPKO Biologics to Host Symposium to Present Clinical Data on its Long-acting Human Growth Hormone at the 49th Annual Meeting of the Japanese Society for Pediatric Endocrinology

OPKO Biologics will host a symposium at the 49th Annual Meeting of the Japanese Society for Pediatric Endocrinology and will present the complete 12-month pharmacokinetic, pharmacodynamic, safety and efficacy data of OPKO’s weekly long-acting growth hormone (hGH-CTP) in naïve growth hormone deficient children. The 49th Annual Meeting of the Japanese Society for Pediatric Endocrinology is […]

OPKO Biologics Presents Clinical Data on its Long-acting Human Growth Hormone (hGH-CTP) in Two Oral Presentations at the 54th Annual Meeting of the European Society for Pediatric Endocrinology (ESPE)

OPKO Biologics presented clinical data from its completed 12-month hGH-CTP Phase 2 pediatric growth hormone deficiency clinical study in two oral presentations at the 54th Annual Meeting of the European Society for Paediatric Endocrinology (ESPE) on October 3, 2015, in Barcelona, Spain. The presentations included pharmacokinetic, pharmacodynamic, safety and efficacy data of OPKO’s hGH-CTP in […]

OPKO Announces Completion of Enrollment in Phase 3 Trial of hGH-CTP in Growth Hormone Deficient Adults

OPKO Health, Inc. has completed enrollment in the single pivotal Phase 3 trial of its long acting human growth hormone (hGH-CTP) in growth hormone deficient (GHD) adults. The trial is designed to evaluate the safety and efficacy of hGH-CTP with a primary endpoint of superiority compared to placebo in decreasing fat mass in adults with […]

OPKO Presented New Data at International Society on Thrombosis and Haemostasis (ISTH) 2015 Congress on Its Long-Acting Clotting Factor VIIa

New Preclinical Data further demonstrate the safety and efficacy of MOD-5014 (FVIIa -CTP) for both Intravenous and Subcutaneous Administration OPKO Health, Inc. presented new data on its long-acting clotting Factor VIIa-CTP (MOD-5014) at the International Society on Thrombosis and Haemostasis Congress (ISTH 2015) held June 20-25, 2015 in Toronto, Ontario, Canada. OPKO’s Factor VIIa-CTP is […]

Twelve Months Data Supporting Once-Weekly Dosing of hGH-CTP in Growth Hormone Deficient Pediatric Population was Presented at ENDO 2015 Conference

OPKO Health, Inc. announced the presentation of two posters at the 97th Annual Meeting of the Endocrine Society (ENDO 2015) on March 5th, 2015 in San Diego, California, that included twelve months data from OPKO’s advanced phase 2 trial for its long acting human growth hormone hGH-CTP in growth hormone deficient pediatric subjects. The presented data […]

OPKO Submits Investigational New Drug Application to Initiate a Phase 2a Trial for its Long-Acting Coagulation Factor VIIa-CTP to Treat Hemophilia

OPKO Health, Inc. announced the submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) to conduct a Phase 2a study of OPKO’s long-acting version of coagulation Factor VIIa (Factor VIIa-CTP) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or […]