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OPKO Health, Inc. (OPK)

  • Today, 5:35 PM
    • OPKO Health (NYSE:OPK): Q4 EPS of -$0.12 may not be comparable to consensus of -$0.06.
    • Revenue of $25.5M (+23.2% Y/Y) beats by $0.9M.
    • Press Release
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  • Today, 9:59 AM
    • Biogen Idec (BIIB -0.5%) and collaboration partner Swedish Orphan Biovitrum AB announce positive top-line results from a Phase 3 trial evaluating Alprolix (Coagulation Factor IX [Recombinant], Fc Fusion Protein) in children under age 12 with severe hemophilia B.
    • Medical professionals recommend prophylactic treatment in children with severe hemophilia in order to manage and/or prevent bleeding episodes, but frequent administration schedules can be burdensome for patients and caregivers. Alprolix is administered once every 7 - 10 days for routine prophylaxis (prevention).
    • In the study, children treated with Alprolix experienced an overall median annualized bleeding rate (ABR) of 1.97, while the median ABR for spontaneous joint bleeds was zero. About one third of the participants had no bleeding episodes at all. Overall, 91.7% of bleeding episodes were controlled by one or two infusions of Alprolix. None of the patients produced inhibitors (antibodies) to Alprolix in the study, which was the most significant potential complication of treatment.
    • The European Medicines Agency requires the inclusion of pediatric study data in the initial Marketing Authorization Application (MAA) for a new hemophilia treatment. Interim data were used in the U.S. New Drug Application (NDA).
    • Alprolix is the only approved hemophilia B therapy with prolonged circulation in the body. The FDA cleared it in March of last year. It generated $25.3M and $40.3M in sales for Biogen in Q3 and Q4, respectively.
    • Related tickers: (BAX +0.3%)(OPK -0.8%)(SGMO -1.9%)(ALNY -1.9%)(ONCE +3%)(PFE -0.2%)(SHPG -1.6%)
  • Thu, Feb. 5, 3:23 PM
    • The resignation of prominent healthcare investor/entrepreneur Dr. Phillip Frost, M.D., from Teva Pharmaceutical Industries' (TEVA +1.8%) Board of Directors prompts aggressive buying from speculators who think a potential deal is afoot with Opko Health (OPK +4.6%). Teva is up on 50% higher volume while Opko's turnover is 3x average.
  • Fri, Jan. 30, 12:31 PM
    • Opko Health (OPK +3.5%) submits an Investigational New Drug Application (IND) to the FDA for clearance to commence a Phase 2a study evaluating its long-acting Orphan Drug-designated coagulation Factor VIIa (Factor VIIa-CTP) for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to Factor VII or Factor IX.
    • Currently, Factor VIIa therapy is administered intravenously which requires multiple infusions, due to its short half-life, to treat a bleeding episode.
    • The longer duration of action of Opko's Factor VIIa-CTP is based on the naturally occurring peptide, C-terminal peptide, of the beta chain of human chorionic gonadotropin (hCG).
    • Opko acquired the rights to the product when it bought Prolor Biotech.
    • Previously: Opko completes its acquisition of Prolor Biotech (Aug. 29, 2013)
    • Related tickers: (BAX +0.4%)(SGMO +0.6%)(ALNY +0.5%)(BIIB +11.4%)(OTCPK:BAYRY -1.4%)
  • Dec. 15, 2014, 9:12 AM
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  • Dec. 15, 2014, 8:56 AM
    • Opko Health (NYSE:OPK) is up 14% premarket on robust volume in response to its deal with Pfizer (NYSE:PFE). The latter will be pay Opko an upfront fee of $295M and up to $275M in regulatory milestones for the global rights to hGH-CTP, a long-acting growth hormone. Its value proposition is a once-weekly injection, a significant improvement over the once-daily standard of care.
    • Opko acquired the rights to hGH-CTP via its takeout of Israel-based Prolor last year.
    • Previously: Opko completes its acquisition of Prolor Biotech (Aug. 29, 2013)
  • Dec. 9, 2014, 12:38 PM
    • RedHill Biopharma Ltd. (RDHL +12.2%) submits a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare Products Regulatory Agency and several other member states seeking approval for the 5-HT3 receptor Bekinda (ondansetron) (formerly RHB-102) for the treatment of cancer therapy-induced nausea and vomiting.
    • The MAA has been submitted under the European Mutual Recognition Procedure with the UK as the reference European member state.
    • The 5-HT3 market is estimated at ~$940M worldwide with Europe representing ~1/3 of the total.
    • CINV-related tickers: (OTC:ESALF) (OTCPK:ESALY -3%) (OPK +1.1%)(GALE +1.8%)(INSY +0.7%)(HRTX +1.3%)(TSRO +2.9%)(GWPH +4.5%)
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  • Nov. 7, 2014, 12:02 PM
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  • Nov. 7, 2014, 8:32 AM
    • OPKO Health (NYSE:OPK): Q3 EPS of -$0.11 misses by $0.04.
    • Revenue of $19.8M (-4.1% Y/Y) misses by $5.37M.
    • Press Release
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  • Oct. 10, 2014, 10:50 AM
    • The FDA approves Akynzeo (netupitant and palonsetron) for the treatment of nausea and vomiting in patients undergoing cancer chemotherapy. Akynzeo is a combination of two drugs. Oral palonosetron, approved in 2008, prevents nausea and vomiting in the acute phase (24 hours) after the start of chemo. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase (25 - 120 hours) after the start of chemo.
    • Akynzeo is distributed in the U.S. by Eisai (OTC:ESALF)(OTCPK:ESALY -0.2%) under license from Lugano, Switzerland-based Helsinn Healthcare S.A.
    • Related tickers: (OPK -1.6%)(GALE -6.1%)(INSY -1.9%)(HRTX -2.7%)(RDHL)(TSRO -0.8%)(GWPH -4.6%)
    | 1 Comment
  • Sep. 23, 2014, 9:48 AM
    • OPKO Health's (NYSE:OPK) oral vitamin D prohormone treatment Rayaldee achieves its primary endpoints in a 216-patient 38-site Phase 3 clinical trial evaluating its safety and efficacy as a treatment for secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency.
    • Rayaldee corrected vitamin D insufficiency in 96% of the patients in its cohort compared to 8% for placebo.
    • The primary efficacy endpoint was a responder analysis where a responder was defined as a patient who demonstrated an average 30% decrease in plasma parathyroid hormone from pre-treatment baseline during the six-week treatment period. The specific proportion of responders and whether it was statistically significant is not disclosed, however.
    • The company expects to submit its NDA by the end of 2014.
    | 1 Comment
  • Sep. 8, 2014, 12:44 PM
    • Opko Health (OPK +1.8%) licensee Tesaro (TSRO -0.5%) submits an NDA to the FDA for oral rolapitant, an investigational neurokinin-1 (NK-1) receptor antagonist for the treatment of chemotherapy-induced nausea and vomiting (CINV).
    • Under the terms of the license agreement, Opko is eligible to receive up to $121M in upfront and regulatory/commercial milestones. It will also receive double-digit royalties on rolapitant sales. The companies will share future profits from the commercialization of rolapitant in Japan and Opko will have the option to market the product in Latin America.
  • Aug. 11, 2014, 6:03 PM
    • Opko Health (OPK -1.1%) Q2 results: Revenues: $23.5M (-1.3%); Net Loss: ($26.1M) (-493.2%); Loss Per Share: ($0.06) (-500.0%); Quick Assets: $134.0M (-27.9%).
    • No financial guidance given.
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  • Aug. 11, 2014, 4:51 PM
    • OPKO Health (NYSE:OPK): Q2 EPS of -$0.06 may not be comparable to consensus of -$0.08.
    • Revenue of $23.5M (-1.3% Y/Y) misses by $0.23M.
    • Press Release
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  • Aug. 10, 2014, 5:35 PM
  • Jun. 27, 2014, 11:42 AM
    • The European Patent Office grants Opko Health (OPK +0.7%) a patent covering Logova, its long-acting CTP-enhanced human growth hormone product. The patent includes composition of matter and associated methods.
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Company Description
Opko Health Inc is a biopharmaceutical and diagnostics company, engaged in the development and commercialization of pharmaceutical products, vaccines, diagnostic technologies, and imaging systems.