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News Breaks
June 23, 2014
14:01 EDTOPKOPKO Health reports positive interim six-month Lagova Phase 2 data
OPKO Health announced 6 month results of a Phase 2 dose-finding study evaluating the safety and efficacy of its novel long-acting human growth hormone product to treat pediatric growth hormone deficiency disorder. All three Lagova once-weekly doses demonstrate strong catch-up growth during the six months treatment. The annualized growth rates are above 12 cm in all three doses. The results are supported by excellent dose dependent pharmacokinetics and pharmacodynamics profiles. Lagova shows a promising safety profile with no serious adverse events reported. Glucose and lipid metabolism markers are within the normal ranges. No lipoatrophy was observed in any patients dosed, and no clinically significant local tolerability issues were identified. “Based on these encouraging safety and efficacy results, OPKO plans to move aggressively into a single confirmatory pivotal Phase 3 study for pediatric GHD patients. We hope to make Lagova available to pediatric GHD patients as soon as possible,” said CEO, Phillip Frost, M.D. “Lagova is one of a family of important products being developed at OPKO Biologics designed to improve compliance and offer ease of administration to patients.”
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September 15, 2014
09:14 EDTOPKOPKO Health launches 4Kscore Test in Europe
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September 11, 2014
09:03 EDTOPKOPKO announces publication of MOD-4023 Phase 2 dose finding study
OPKO Health announced that the abstract “Top Line Results of Once-Weekly, CTP-Modified Human Growth Hormone: Phase 2 Dose Finding Study in Children with Growth Hormone Deficiency" has been selected for late breaking oral presentation at the 53rd Annual Meeting of the European Society of Paediatric Endocrinology on September 20. OPKO will present six month efficacy, safety, pharmacokinetic and pharmacodynamics data from the company's advanced phase 2 trial for its long acting human growth hormone hGH-CTP, or MOD-4023, in growth hormone deficient pediatric subjects. In addition, OPKO’s posters to be presented during the conference have been recognized for outstanding advancement by ESPE and will introduce additional data, as well as analytical characteristics of hGH-CTP in preparation for the planned pediatric phase 3 study. The data from this study supported once-weekly dosing for hGH-CTP and also enabled the selection of an appropriate dose to demonstrate non-inferiority compared to daily hGH in the upcoming phase 3 study. hGH-CTP demonstrated a good safety and tolerability profile in this ongoing study.
September 8, 2014
12:22 EDTOPKOPKO reports licensee TESARO submits NDA for Rolapitant
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