Recent

% | $
Quotes you view appear here for quick access.

Omeros Corporation Message Board

dooper55 14 posts  |  Last Activity: May 10, 2016 7:58 AM Member since: Dec 9, 2006
SortNewest  |  Oldest  |  Highest Rated Expand all messages
  • SEATTLE--(BUSINESS WIRE)-- Omeros Corporation(OMER) , a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, today announced that the company will issue its fourth quarter and year-end 2015 financial results for the period ended December 31, 2015, on Tuesday, March 8, 2016, before the market opens. Omeros(OMER) management will host a conference call and webcast that day at 9:00 a.m. Eastern Time (6:00 a.m. Pacific Time) to discuss the financial results.

  • Omeros to Present at the Cowen and Company 36th Annual Health Care Conference
    BUSINESS WIRE 5:00 AM ET 3/3/2016

    SEATTLE--(BUSINESS WIRE)-- Omeros Corporation(OMER) , a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the Cowen and Company 36th Annual Health Care Conference in Boston next week. The presentation is scheduled for Wednesday, March 9, 2016 at 8:40 a.m., EST.

    The presentation will be webcast. The live and archived webcasts can be accessed on the “Events” page of the Company’s website.

  • For 4Q 2015, sales revenues of OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% were $6.7 million, a 105% increase over 3Q, with OMIDRIA units shipped by wholesalers (“sell-through”) increasing 74% over 3Q.

  • -- Single Pivotal Study Needed for Phase 3 --

    SEATTLE--(BUSINESS WIRE)-- Omeros Corporation(OMER) , a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, today announced that it has initiated its Phase 3 OMS721 program for the treatment of atypical hemolytic uremic syndrome (aHUS) after meeting with the U.S. Food and Drug Administration (FDA). OMS721 is Omeros’ lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of thrombotic microangiopathies (TMAs), including aHUS. The FDA has awarded OMS721 both orphan drug designation for the treatment of TMAs and fast-track status for the treatment of aHUS.

    The OMS721 Phase 3 program will consist of one clinical trial – a single-arm (i.e., no control arm), open-label trial in patients with newly diagnosed or ongoing aHUS. The clinical package for the biologics license application (BLA) will be similar to that which formed the basis of approval for Soliris® (eculizumab). For the BLA, safety of OMS721 can be demonstrated in patients across a wide range of diseases instead of only in those with aHUS, including additional renal diseases for which Omeros(OMER) is already enrolling a clinical trial. As a result, collection of safety data is not expected to delay submission of the BLA. Omeros(OMER) also received agreement from FDA on its ongoing manufacturing for both the Phase 3 program and commercialization of OMS721 as well as on its nonclinical safety and toxicology plan, most of which has already been successfully completed with no significant adverse findings. Phase 3 enrollment is expected to begin later this year and patients currently being treated in the Phase 2 trial are likely to be included in the Phase 3 program.

    [more in news release]

  • Provectus Biopharmaceuticals Changes Date of Quarterly Business Update Conference Call to Wednesday March 16, 2016, at 4 pm (EDT)
    BUSINESS WIRE 4:00 AM ET 3/10/2016

    Call Moved to Coincide with Filing of 10-K with SEC

    KNOXVILLE, Tenn.--(BUSINESS WIRE)-- Provectus Biopharmaceuticals, Inc.(PVCT) , a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or “the Company”), today announced that it is changing the date for its fourth quarter and year-end conference call to Wednesday March 16, 2016, from March 10, 2016. The call will take place at 4 pm EDT that day.

    The Company is rescheduling the call to coincide with the filing of its Annual Report on Form 10-K with the SEC expected to occur on Tuesday March 15, 2016. The Company believes that the change will enable more comprehensive discussion from the Company to stockholders during the conference call on Wednesday March 16th. Further, it will permit CTO Eric Wachter, who is traveling, to participate in the call and answer questions from stockholders regarding the development of the Company's investigational drug candidates.

  • Reply to

    WHAT EVERYONE IS MISSING HERE:

    by pvct_fraud Mar 10, 2016 11:00 AM
    dooper55 dooper55 Mar 10, 2016 11:28 AM Flag

    On the other hand p_f, what YOU seem to be missing is that PV-10 is extraordinarily safe and effective in treating solid tumors. That has been and continues to be verified by well qualified independent entities. I don't claim PVCT management is perfect but I believe your criticism of them is seriously overdone.

    Have a good day!

  • That's a Motley Fool headline today

    End of article ......

    "Last August, a small mid-stage study of Omeros Corporation's OMS721 showed OMS721 improved platelet count from baseline in three aHUS patients.

    That's important because improvement in platelet count can indicate a reduction in disease activity.

    Following a meeting with the FDA to discuss those mid-stage results, Omeros Corporation announced this week that it will start enrolling patients in a single phase 3 aHUS trial later this year.

    If that trial goes smoothly, Omeros Corporation may not have to wait long to challenge Alexion Pharmaceuticals' dominance. The FDA has awarded OMS721 orphan drug designation and fast-track status, and it has said it will allow Omeros Corporation to use safety data from non-aHUS patients in order to accelerate the application timeline.

    Payers are probably motivated to see a new competitor hit the market, too. Soliris costs $537,000 in the United States, and last year, it generated $2.6 billion in sales for Alexion Pharmaceuticals -- a lot of which was from aHUS patients.

    Looking ahead
    There's no guarantee Omeros Corporation's OMS721 will be as effective or as safe as Soliris, or that if it is, the FDA will approve it. However, if OMS721 does make its way to market, it could represent a game-changing drug for Omeros Corporation. Currently, the company's revenue comes solely from sales of its cataract surgery drug Omidria, and given that Omidria's quarterly sales were just $6.7 million last quarter, it's far from a barn burner.

    Ultimately, Alexion Pharmaceuticals could be forced into a price war by OMS721 that dents its top and bottom lines, and for that reason, Alexion Pharmaceuticals investors will want to keep close tabs on Omeros Corporation's progress."

  • SEATTLE--(BUSINESS WIRE)--Apr. 7, 2016-- Omeros Corporation (NASDAQ:OMER), a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the 15th Annual Needham Healthcare Conference in New York next week. The presentation is scheduled for Wednesday, April 13, 2016, at 2:20 p.m. EDT.

    The presentation will be webcast. The live and archived webcasts can be accessed on the "Events" page of the company's website.

  • FWIW, I had been assuming that the Omidria program within OMER was projected to become cash flow positive later this year. However, at the end of the brief Q&A today, Demopulos stated explicitly that the Omidria program is already cash flow positive and that they expect Omidria to make OMER, the full company, cash flow positive later this year.

  • Patient Dosing Initiated for OMS721 Phase 2 Program in Renal Diseases

    Date(s): 20-Apr-2016 7:00 AM

    -- Study Provides an Opportunity for Breakthrough Therapy Designation and Subsequent Accelerated Approval --

    SEATTLE--(BUSINESS WIRE)--Apr. 20, 2016-- Omeros Corporation (NASDAQ: OMER) today announced initiation of patient dosing in its OMS721 Phase 2 program in corticosteroid-dependent renal diseases. The Phase 2 clinical trial of OMS721, the company's lead mannan-binding lectin-associated serine protease-2 (MASP-2) inhibitor being developed for complement-related diseases, is evaluating the effects of OMS721 on kidney function in patients with corticosteroid-dependent renal diseases. This new trial expands the company's MASP platform, which includes an OMS721 Phase 3 program in progress for the treatment of atypical hemolytic uremic syndrome (aHUS) as well as an ongoing Phase 2 program of OMS721 for the treatment of other thrombotic microangiopathies (TMAs).

    This new Phase 2 clinical trial includes patients with corticosteroid-dependent IgA nephropathy, membranous nephropathy, C3 glomerulopathy and lupus nephritis. Evidence implicates the complement system, and specifically the lectin pathway, in the pathogenesis of each of these serious diseases. Despite ongoing treatment with corticosteroids, these patients have evidence of progressive kidney disease and are at high risk for kidney failure and dialysis. Continued corticosteroid use carries significant patient risks and is associated with serious side effects. There are no FDA-approved treatments for corticosteroid-dependent patients who have persistent renal inflammation. Treatments for these diseases that improve kidney function, slow disease progression or avoid long-term corticosteroid use would meet a significant unmet medical need.

    (Much more in the news release.)

  • Omeros Corporation Announces Independent Studies with OMIDRIA® to Be Presented at Upcoming Ophthalmology Congresses

    26-Apr-2016 7:00 AM

    -- Studies Assessed Key Surgical Outcome Measures Including Complication Rates --

    SEATTLE--(BUSINESS WIRE)--Apr. 26, 2016-- Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, today announced that new research related to the clinical utility of OMIDRIA (phenylephrine and ketorolac injection) 1% / 0.3% and the importance of preempting intraoperative miosis and inflammation during cataract surgery will be presented at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2016 Annual Meeting in Seattle, Washington, May 1 - 5, 2016, and the American Society of Cataract and Refractive Surgery (ASCRS) Congress in New Orleans, Louisiana, May 6 - 10, 2016. Presentations will address the beneficial effects demonstrated in case-controlled studies of OMIDRIA on complication rates, on use of pupil-expanding devices, on surgical times and on postoperative visual acuity.

    "As utilization of OMIDRIA in cataract surgery continues to grow, we are accumulating a wealth of data across varied ophthalmic conditions, clinical settings and practice patterns," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "These findings underscore the important benefits of OMIDRIA to both patients and surgeons - improving outcomes, streamlining procedures and reducing risks."

    (News release lists all of the studies)

  • dooper55 dooper55 May 9, 2016 12:23 PM Flag

    Q1 results will be out Tuesday morning ......

    May 4, 2016-- Omeros Corporation ..... , today announced that the company will issue its first quarter 2016 financial results for the period ended March 31, 2016, on Tuesday, May 10, 2016, before the market opens. Omeros management will host a conference call and webcast that day at 9:00 a.m. Eastern Time (6:00 a.m. Pacific Time) to discuss the financial results.

  • dooper55 dooper55 May 9, 2016 1:40 PM Flag

    So? This time they've said it'll be Tuesday morning, before the cc.

  • From the news release .....

    1Q 2016 revenues were $7.4 million, an 11% increase over 4Q 2015.

    OMIDRIA units shipped by wholesalers (“sell-through”) increased 20% over 4Q 2015.
    OMIDRIA sales accelerated substantially in the second half of 1Q, with March accounting for nearly 50% of quarterly sales.
    OMIDRIA sales growth trajectory has continued into 2Q with sales to date approximately 65% higher than the corresponding period in 1Q.
    Based on recent sales activity, net sales of OMIDRIA, without any additional growth, annualize to an approximate run rate of $45 million to $50 million.

    “OMIDRIA sales continued to grow substantially in Q1,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros(OMER). “Growth in the first part of the quarter was relatively restrained due to both internal and external factors, with sales markedly ramping in March. The acceleration in sales growth has continued into the second quarter, with the run rate for OMIDRIA net sales in recent weeks annualizing to approximately $45 million to $50 million. We continue to expect that we will reach cash-flow positive status later this year, fully funding our pipeline. That pipeline continues to advance, with OMS721 entering a Phase 3 program for aHUS and two OMS721 Phase 2 trials ongoing in TMAs and renal disease. The remainder of the pipeline is progressing nicely, and 2016 is shaping up to hold a number of value-driving milestones.”

OMER
11.42+0.12(+1.06%)May 27 4:00 PMEDT