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Omeros Corporation (OMER)

NasdaqGM - NasdaqGM Real-time price. Currency in USD
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3.1500-0.0700 (-2.17%)
At close: 04:00PM EDT
3.2400 +0.09 (+2.86%)
After hours: 06:06PM EDT

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  • B
    When the NoPain Act is passed, Omeros will receive a $200M milestone payment = $3.20 per share.
    Omidria sales in 2023-2024 should reach $200M. The 30% royalty = $60M earnings direct to the bottom line = $1.00 per share. At a PE of 20 = $20. So Omidria has a value of $23.20 per share. Then the pipeline: 3 drugs in P3, 2 drugs in P2 and 2 drugs in P1 = OMER is a grossly undervalued stock. See ya at $40.
  • c
    Hi again. I still here. I sleep very well how about you
  • J
    Here is an interesting quote:

    – Independent data monitoring committee recommends pausing study enrollment due to lack of efficacy in pre-specified interim analysis –

    ~ The IDMC’s recommendation was based on a pre-planned interim analysis of the primary endpoint – survival at Day 29 – once 122 patients completed the 29-day primary evaluation period. No secondary endpoints were analyzed as part of the interim analysis. -

    It comes from the Ultomiris (alexion/AZN) trial for covid-19.

    Ultomiris = lack of efficacy
    Narsoplimab = reduction in morbidity

    Which one is better? The question is rhetorical.

    Ultomiris has just been given approval for myasthenia gravis. It has aHUS and PNH approval and is being used off label for HSCT-TMA. If Narsoplimab is approved AZN will have some serious competition. Narsoplimab is a drug without a black box warning which treats the disease upstream instead of allowing it to wreak havoc in the body.

    Narsoplimab for some is not a cure, it is a malady.
  • U
    Head ScratcherQLHC released a Press Release and posted it on their website the results for every drug that had reached its conclusion. All, 8 or 9, whatever, had reached the futility criteria. All these results were also posted here, for reasons that has me scratching my head, the NARSO results were never posted, not yet anyway, on either site. Not posted on QLHC's own I-Spy website. Some here speculate that the FDA was attempting to reach out to QLHC for their results. Long ago (spring) I floated this idea, that the FDA may also consider these results as part of their review. But soon after we learned that the FDA rejected the Type A Meeting data, and I-Spy was out of site out of mind.To be clear, COVID and TMA are completely different indications, but may have similarly benefit from NARSO.. The FDA looking for evidence of of treatment effectiveness, and if NARSO passed in I-SPY that would be at least some evidence it worked somewhere. Would the FDA even take into consideration looking at the results for a completely different indication? I don't know and am somewhat suspect. However, these PRs released by OMER and none from QLHC, may be OMER playing hardball with QLHC, telling them, you have the results, we need them released. And even though the results disappointed, OMER releases a second PR to explain why and show NARSO in a much more favorably light. And now the FDA has another data point to possibly use....possibly. My opinion is it is unlikely, not definitely, but unlikely the FDA had anything to do with this. And similarly its unlikely that this was the additional info that the FDA was seeking. I think this is OMER being aggressively pro-active, telling these mopes, 'hey you #$%$ mopes, we have been patient long enough and we need something to send over the bough to the FDA in these waning critical days of the review process". And the fact that QLHC did not bother to post this info to their own site tells me that they have yet to cross all the T's and dot all I's on their own final analysis. It's my belief that they reluctantly agreed to let OMER release the joint PR which was fairly scant on details.And I would not be surprised at all if OMER did not let QLHC know about the second PR that explains the lameness of the I-Spy NARSO Trial. The "joint" PR provides an "about" paragraph for the I-Spy Trial, QLHC, as well as OMER. The second PR only mentions "about" OMER. QLHC had nothing to do with this second PR, after all it shows how lame the trial, and by extension QLHC isSo does it help? I can't hurt that the FDA would be made aware directly by OMER. But it also may have been a gesture of desperation. Will we ever know exactly what transpired? If we do, I think only if something positive comes from the FDA as GD does a victory lap. But even then who knows..
    COVID News Coverage
  • b
    Stock grants issued last week are nearly 20% underwater.
  • O
    Does anyone know when our infamous Dr. D submitted the additional information to the FDA?
  • S
    Raining with buckets of money.
    $40 in reach.
    For the entire company.
  • O
    Ok can some explain the big stock option give away at OMEROS?
  • J
    ISB was established by Leroy Hood, a long standing OMER director. They are researching long covid.

    ''James Heath of the Institute for Systems Biology in Seattle focuses his research on identifying factors that would put patients at risk of long Covid, applying multi-omic tools to query blood samples, electronic health records, and questionnaires. His work has turned up clues to what higher levels of autoantibodies — an antibody that the immune system aims at the body’s own proteins — mean when they set off a cascade of immune responses. In the cohort he studied, the presence of autoantibodies wasn’t strongly associated with disease severity, but they were linked to gastrointestinal problems and changes in exercise capacity. Some specific autoantibodies activated a particular immune pathway, one that the monoclonal antibody narsoplimab targets. Heath’s team has designed and proposed to the NIH a clinical trial to test the drug to treat long Covid patients, especially those who can be identified through the specific autoantibodies he has identified.''

    Nice to get some funding, hopefully. Question? If it warrants research in long covid, wouldn't it be also likely to work in the acute setting ..... I-Spy trial showed signs of efficacy. After all, QLHC wanted to do a new trial and changed the protocols accordingly.

    The value is there in Omeros' complement franchise. The question is how is it unlocked, and when?
  • b
    Last year's stock grants were at a price of $14.99. Down slightly this year to $3.93 or over a 70% decline.
  • T
    The real Onyxpig
    When did the 30 day clock start or has it?
  • O
    I hope the FDA reads this from part of the PR from Sept 15 "The study did not identify any new safety signals for narsoplimab in the setting of critically ill COVID-19 patients."
  • s
    "The analysis in the randomized patient population, INCLUDING THOSE WHO DECLINED TREATMENT AFTER RANDOMIZATION,"

    That's why the "reduces mortality risk" statement is even more positive than the results released today. Imaging adding about 20 "0" to a list of numbers of about 91 in total, and trying to find an average. The results would be skewed to a way lower range. That's essentially what they did to get the results published today. And inspite of this they found Narso was still able to reduce mortality - "Despite narsoplimab treatment exposure in a limited number of patients in this trial, a substantial efficacy signal was observed in reducing the risk of mortality for critically ill COVID-19 patients."

    "The analysis in the randomized patient population, including those who declined treatment after randomization, shows that the addition of narsoplimab to treatment of critically ill patients with COVID-19 reduces mortality risk (hazard ratio [HR]=0.81 with probability [HR <1] equal to 0.77).

    Neither futility nor graduation criteria were met in the analysis of the randomized population at the time the narsoplimab arm was terminated."

    "To protect against potential bias associated with analysis only in the consented population, QLHC also prespecified analyses based on all randomized patients (the industry-standard intent-to-treat population)."
  • b
    Are we getting our answer without seeing it yet?
  • b
    Six weeks ago, Aug 11, 2022 7.3900 7.7500 6.9600 7.2000 7.2000 786,500 Down nearly 60% and needs to go up nearly 150% to get back there.
  • C
    It is interesting to note that QLHC doesn’t even mention in their PR why enrollment in NARSO was terminated to save their face.

    I can imagine that GD must have been very frustrated and mad with QLHC and it would have made it impossible for him to do more business with QLHC after knowing they don’t have the competency to conduct any clinical trials.
  • M
    Market is very negative as the Fed continues to increase interest rates. BIOs tend to trend better in this environment as they are not impacted by inflation directly. Looks like OMER is just going to sit there until we hear about the FDA. Anybody have a thought on when that maybe will happen. Seems like sometime in October. I would not be surprised to see a positive outcome from that based on all the info we have seen and how the CMS deal worked out. I was pleasantly impressed with that process.
  • J
    Two press releases were issued within 4 minutes of each other. Both are on Omeros' website. The first was effectively a joint statement which supplied bare facts but included a statement to the efffect that Naroplimab ''reduced mortality'' while neither graduating or failing/futility, ie inconclusive.

    The second PR was from Omeros which provided two very important pieces of information which explained why the trial was technically inconcluive but also positive for Narsoplimab. The first was confirmation that only 91 patients were randomised to the Narsoplimab arm instead of the anticipated 125. The trial was effectively terminated prior to full enrolment because of the biased analyses in the consented population prior to reaching the maximum of 125 patients. Ie. the review board figured out that they had botched it and it was pointless to go on.

    The second was that 50% of the patients that died in the narsoplimab arm received very little or none of the drug. To still provide a noticable reduction in mortality in the face of such a hurdle is VERY positive. GD was not lying irregardless of how the market reacted. As this data is not going to be submitted to the FDA for any approval a sub group analysis of all patients who had taken a reasonable ampount of drug compared to a like sample of the standaed of care group would in my opinion be very enlightening, and positive. The data is there. Will anyone do it? Do they dare?.

    In the joint PR there was the below statement which still holds true. The data confirms it to have been a wise choice ...............

    ''Narsoplimab was selected for inclusion in the I-SPY COVID Trial because of its demonstrated ability to inhibit complement activation, inflammation, and coagulation, the three components that characterize COVID-19.''
  • T
    The real Onyxpig
    “for various reasons”…decider that statement now! How about for a variety of reasons or for a number of reasons. So besides a flawed study, what else don’t we know:(
  • J
    1. GD did not design I-Spy trial
    2. All other drugs failed/futility
    3. Narsoplimab showed improved mortality in spite of the fact that 50% of those designated for treatment did not effectively receive it.
    4. A sub group analysis of those patients that actually received a reasonable minimum treatment level may well show statistical analysis.

    This is not a failure. It is positive.