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Omeros Corporation (OMER)

NasdaqGM - NasdaqGM Real Time Price. Currency in USD
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20.90+0.21 (+1.01%)
At close: 4:00PM EDT

20.90 0.00 (0.00%)
After hours: 4:35PM EDT

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  • K
    KENNETH
    KENNETH
    Don't understand the name calling & the individual bashing. Pretty new to this but where is the respect & assisting each other with info that will help us all to be more successful in investing in this stock or in any other Security
  • J
    JohnnyB
    JohnnyB
    unfortunately there are these childish, uneducated clowns names "billyboy" "greatday" "brian" that ruin the board with their pathetic garbage. put em all on ignore
  • b
    ben
    ben
    At least six potentially positive PR's due out before year end. Par lawsuit results, pass thru status for 2018, European partner, final P2 for Igan trial, start of P3 for Igan, start of P3 for stem cells, Q3 results. Feel free to add to the list.
  • A
    Andy
    Andy
    This is the final boarding call for the OMER express TRAIN..don't miss it or you will be sorry!!!
  • J
    J
    J
    Good news is coming. Soon.
  • J
    JohnnyB
    JohnnyB
    little billy, way to put that harvard degree to work, posting hour after hour about some moron called greatday.
  • T
    The Duke
    The Duke
    Nice to see back to $21, though no volume/news. Should be time for some news..........
  • A
    Andy
    Andy
    Does anyone know when the Par lawsuit will be over? As soon as that is over the EU partnership should happen.
  • b
    ben
    ben
    Aug. and Sept. 2017 playing out like Aug. and Sept. 2016.
  • K
    KENNETH
    KENNETH
    What was the exercise price for the 450,000 shares and when does it expire?
  • b
    ben
    ben
    Light volume and no news in over a month, will do it every time.
  • A
    Andy
    Andy
    I got to thank you guys for free entertainment during OMER's intermission!!
  • g
    g10378
    g10378
    According to the Centers for Disease Control and Prevention, more than 10 percent of American adults – about 20 MILLION people — have chronic kidney disease. Dr. Poggio says 600,000 are on dialysis and 100,000 are on the waiting list for a kidney transplant. Yet only 16,000 transplants are done each year.Jul 28, 2014
  • J
    John
    John
    The FDA is passing everything as long as you tell (R) congressmen before hand so they can cash in.
  • b
    ben
    ben
    Is Omeros going to be there ? Last month, just before her book “What Happened” was published, Barack Obama spoke in New York to clients of Northern Trust Corp. for about $400,000, a person familiar with his appearance said. Last week, he reminisced about the White House for Carlyle Group LP, one of the world’s biggest private equity firms, according to two people who were there. Next week, he’ll give a keynote speech at investment bank Cantor Fitzgerald LP’s health-care conference
  • Y
    YuchenZ
    YuchenZ
    Hoping have great news on Monday
  • b
    ben
    ben
    Since 2012 OMER has raised cash every year for a total over $300 million need results.
  • b
    ben
    ben
    this was 4 years ago, FDA Grants Orphan Drug Designation to Omeros' OMS721 for Complement-Mediated Thrombotic Microangiopathies

    -- Phase 2 Program Expected to Begin Next Quarter --

    SEATTLE, Dec. 18, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for prevention of complement-mediated thrombotic microangiopathies (TMAs).

    TMAs, including atypical hemolytic uremic syndrome and thrombotic thrombocytopenic purpura, are a family of rare, debilitating and life-threatening disorders characterized by multiple thrombi (clots) in the microcirculation of the body's organs, most commonly the kidney and brain. The lectin pathway, one of the principal complement activation pathways in the immune system, is thought to play a central role in the development of TMAs. By targeting MASP-2, OMS721 specifically blocks the lectin pathway. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.

    Omeros is completing a Phase 1 study to assess the safety and pharmacokinetics of OMS721. As previously announced, at the highest subcutaneous dose administered to date in this study, OMS721 achieved serum concentrations that resulted in a high degree of inhibition of lectin pathway activation. The serum concentrations seen in the Phase 1 subjects are similar to those associated with efficacy in animal models of diseases, including TMA, linked to the lectin pathway. Omeros expects to report additional Phase 1 clinical data in early 2014. The Phase 2 clinical program evaluating OMS721 for the prevention of complement-mediated TMAs is expected to begin in the first quarter of 2014.

    "We are pleased that the FDA has granted orphan drug designation for OMS721. The designation should accelerate the development of OMS721 and, given the limitations of current treatments for TMAs, we look forward to initiating our Phase 2 clinical program next quarter," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "The remainder of this year and the first part of 2014 promise to be exciting times across other Omeros programs as well. This month we will initiate our OMS824 Phase 2 clinical program in Huntington's disease – earlier granted orphan drug designation by the FDA – and could also report Phase 2a data for OMS824 in schizophrenia. We then look to the potential marketing approval of Omidria™, its launch completing our transition to a commercial company."

    Orphan designation by the FDA is granted to promote the development of drugs that target conditions affecting 200,000 or fewer U.S. patients annually and that are expected to provide significant therapeutic advantage over existing treatments. Orphan designation qualifies a company for benefits that apply across all stages of drug development, including accelerated approval process, seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and waiver of certain administrative fees.
  • S
    Stocktraderathome
    Stocktraderathome
    heavy volume at the close
  • g
    g10378
    g10378
    Facts about Omidria Pass-Through ( You can Google it)
    OMIDRIA
    After nearly 13 years of research and development, OMIDRIA (phenylephrine and ketorolac injection) 1% / 0.3% received FDA
    approval in May 2014. Added to ophthalmic irrigation solution used during cataract surgery or intraocular lens replacement,
    OMIDRIA is the only FDA-approved intraocular product for maintaining pupil size by preventing miosis and for reducing
    postoperative ocular pain.
    In October 2014, the Centers for Medicare and Medicaid Services (CMS) granted pass-through reimbursement status to OMIDRIA,
    which became effective January 2015. Pass-through status for OMIDRIA will expire on December 31, 2017.
    Pass-Through Status1
    In 2001, Congress established the pass-through regulation as law to promote and foster the use of innovative new drug and
    device technologies to benefit Medicare patients.
    Under the Outpatient Prospective Payment System (OPPS), pass-through products are paid separately (i.e., in addition
    to the bundled facility fees) by Medicare when the product is used in ambulatory surgery centers (ASCs) or in hospital outpatient
    departments (HOPDs).
    Pass-through status is transitional—if CMS awards a product pass-through status, it lasts for no less than two years and no more
    than three years.
    It allows CMS to track the utilization of the product so that, if it is used during a procedure, CMS can appropriately adjust the
    associated facility fees when the product’s pass-through status expires and the product is ultimately included in the bundled
    payment.
    Reimbursement of the Pass-Through Product OMIDRIA in ASCs and HOPDs
    Medicare Part B
    The payment rate authorized and listed by CMS for OMIDRIA is the wholesale acquisition cost plus 6 percent (WAC+6%) or $492.90
    per vial through September 30, 2015 after which the payment rate will be the average selling price plus 6 percent (ASP+6%).
    There is no co-payment for OMIDRIA in the HOPD setting. In the ASC setting, the patient may be subject to a 20% co-payment.
    Approximately 90% of Medicare Part B patients have some form of supplemental insurance, which covers co-payments. 2 Omeros
    is working to establish a patient assistance program to provide funding support to those patients who meet certain financial
    criteria.
    Medicare Part C (Medicare Advantage) and Commercial
    Medicare Advantage and commercial payers usually follow Medicare Part B.
    Before using OMIDRIA in patients with Medicare Advantage or commercial coverage, obtain prior authorization or confer with
    your payers.
    OMIDRIA Will Have a Positive Effect on Facility Fees1
    Each year, CMS sets aside a pool of funds for all pass-through payments. The estimated utilization of all pass-through products
    during each year is used to determine the amount to set aside for the following year. As a result, in 2015, OPPS payment rates for
    all facility services in the HOPDs and ASCs were reduced by a nominal 0.13%. Over the past 10 years, the annual reduction across
    facility fees has ranged from 0.02%–0.22%.
    In 2016 and 2017, OMIDRIA is not expected to have any meaningful effect on facility fees because for each of those years:
    • OMIDRIA will be only one of a substantial number of drugs and devices awarded pass-through status.
    • The reduction is spread over all services for which Medicare pays in HOPDs and ASCs, not just cataract surgery
    or even ophthalmology services.
    After December 31, 2017, pass-through payments for OMIDRIA terminate and CMS is expected to include OMIDRIA in the
    bundled facility fee for cataract surgery.
    As a result of OMIDRIA being bundled, the facility fees for cataract surgery are expected to increase by an amount that
    correlates with the magnitude of OMIDRIA utilization during its pass-through status.
    OMIDRIA Will Have No Effect on Physician Fees
    Payment to the surgeon for cataract surgery under Medicare’s Physician Fee Schedule will be unaffected by the use
    of OMIDRIA or the pass-through payments related to OMIDRIA, now and in the future.
    OMIDRIA Will Have No Effect on the Healthcare System
    The pass-through regulation is budget-neutral to the healthcare system.
    To the extent that ophthalmic surgeons/facilities elect not to access pass-through payments, the funds set aside will be used
    by other specialties. Any remaining amount will be lost to the system.
    Congress and CMS are committed to facilitating access to innovative new technologies through the pass-through regulation for
    the benefit of Medicare patients. Despite pressures to cut the government budget, Congress has not rolled back the pass-through
    regulation, again leaving it intact in the most recent major medical bill—repealing the Sustainable Growth Rate (SGR).