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Omeros Corporation (OMER)

NasdaqGM - NasdaqGM Real-time price. Currency in USD
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15.84+0.02 (+0.13%)
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  • n
    noah
    Price target just raised !
    Do your DD right now :
    [1] Narso approval Oct 17, or sooner, and with adequate launch supplies, I would assume price negotiations are already underway, with the relevant parties.
    [2] The Narso MAA application, to the EMA, should be submitted by Oct, and approval from the EU may very well come by year end.
    [3] Very good chance we see some I-SPY Covid results by Oct 30th, and those results could be best in class.
    [4] OMS 906 phase 1 results should be out by Nov. A once monthly subcutaneous complement pathway drug, as a follow-on to Narso, would enhance our buyout value tremendously.
    [5] IGaN trial enrollment greatly delayed by Covid (N=280), so likely no results until late Q1, 2022.
    [6] Once approval is in hand, for TMAs, a substantial capx raise, north of $30/share, should take place, enabling a full phase 2/3 Narso trial in Lupus.
    [7] I was surprised by Greg's emphasis on GPR174 for cancer, and am hopeful we see an IND, by Nov. A broad based onco therapy, highly synergistic with many types of cancer treatments, might be worth five times the current MC, by itself.
    Last, with a broad, and extremely promising pipeline, OMER is very deeply undervalued, here.
  • s
    siserv2001
    This was all about the hedge shorts closing their September options. It was almost as perfect as painting the tape. Will GD delay a capital raise for 90 days? While practically everyone knows GD sold a planned sell at $17.84 this past June, he also had thought he had a PDUFA scheduled for July 17, 2021. Most think it's highly probable for Narsoplimab to be approved come October 17th 2021. Too late to draw any significant revenues for this year. Now we'll likely have to wait 18-24 months before FDA renders positive news and AHUS is not on anyone's map to get approved. GD likes to start another to seemingly distract shareholders with delayed or bad news. Twenty nine days and really no PR's since the ER. Anyone want to cheer me up? I sound pretty bearish. Let's hope to see lots of news regarding OMER in the next couple of weeks and not stopping til the stock price eclipses our wildest expectations.
  • B
    Billy Boy
    If you were just an outside investor looking in at OMER you would never know that they have a drug to the FDA for PDUFA in less than a month. The volume and price action would provide you no clue.
  • l
    longvrts
    Report: this 7/5 epub just showed up on my search prompt. Covid-19 binds directly to Masp-2 and activates the complement pathway. Narsoplimab highly effective in blocking activation of LP-mediated complement activation. Positive results with Narso in early stage Covid-19 clinical trials are consistent with mechanism reported here:

    Front Immunol. 2021 Jul 5;12:714511. doi: 10.3389/fimmu.2021.714511. eCollection 2021.

    Lectin Pathway Mediates Complement Activation by SARS-CoV-2 Proteins

    Youssif M Ali 1 2, Matteo Ferrari 1, Nicholas J Lynch 1, Sadam Yaseen 3, Thomas Dudler 3, Sasha Gragerov 3, Gregory Demopulos 3, Jonathan L Heeney 1, Wilhelm J Schwaeble 1

    Affiliations
    1Department of Veterinary Medicine, School of Biological Sciences, University of Cambridge, Cambridge, United Kingdom.
    2Department of Microbiology and Immunology, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.
    3Omeros Corporation, Seattle, WA, United States.
    PMID: 34290717 PMCID: PMC8287855 DOI: 10.3389/fimmu.2021.714511
    Free PMC article

    Abstract
    Early and persistent activation of complement is considered to play a key role in the pathogenesis of COVID-19. Complement activation products orchestrate a proinflammatory environment that might be critical for the induction and maintenance of a severe inflammatory response to SARS-CoV-2 by recruiting cells of the cellular immune system to the sites of infection and shifting their state of activation towards an inflammatory phenotype. It precedes pathophysiological milestone events like the cytokine storm, progressive endothelial injury triggering microangiopathy, and further complement activation, and causes an acute respiratory distress syndrome (ARDS). To date, the application of antiviral drugs and corticosteroids have shown efficacy in the early stages of SARS-CoV-2 infection, but failed to ameliorate disease severity in patients who progressed to severe COVID-19 pathology. This report demonstrates that lectin pathway (LP) recognition molecules of the complement system, such as MBL, FCN-2 and CL-11, bind to SARS-CoV-2 S- and N-proteins, with subsequent activation of LP-mediated C3b and C4b deposition. In addition, our results confirm and underline that the N-protein of SARS-CoV-2 binds directly to the LP- effector enzyme MASP-2 and activates complement. Inhibition of the LP using an inhibitory monoclonal antibody against MASP-2 effectively blocks LP-mediated complement activation. FACS analyses using transfected HEK-293 cells expressing SARS-CoV-2 S protein confirm a robust LP-dependent C3b deposition on the cell surface which is inhibited by the MASP-2 inhibitory antibody. In light of our present results, and the encouraging performance of our clinical candidate MASP-2 inhibitor Narsoplimab in recently published clinical trials, we suggest that the targeting of MASP-2 provides an unsurpassed window of therapeutic efficacy for the treatment of severe COVID-19.

    Keywords: COVID-19; SARS-CoV-2; complement system; innate immunity; lectin pathway.
  • M
    MR
    I thought the 9/13 SA article was fairly accurate and as most of the longs holding back our true excitement over this stock. As we all know Biotech is a high risk high reward investment with only the FDA approval process as the first major real hurdle to overcome. Scale up has already been achieved and there appears to be significant demand for Narso as a TMA treatment and or COVID. As I have said in recent posts there is a strong base formed at 16 with the expected upcoming announcement in 30 days. As in 2018, 2019, 2020 the current base that has formed represents the jumping off point for a 3x move within 3-7 days of the news. This is based on a number of factors including over 10m shares short. For each of the last 3 years the move was followed by a drop within 3 months of the potential that was presented. Never an actual revenue building approval. This has been a short players dream company. Personally I believe GD was part of this manipulation as he needed to work with the sophisticated MM on there strategies to make money in order for him to secure financing to keep the dream alive. You can see the strategy of covering the short position with 30-35 option calls as the insurance if the short position needs to be covered. Either which way they win..... For the long term share holder, once an actual product is approved there is a chance for a more longer term prediction of revenues and profits. Personally, I believe we have finally arrived at the place where we will see a 5B initial Market cap( 45, then 65 SP) before the end of the year. That would be a good place to sell the majority of the holdings and keep some if things an actually build value to the 10B mark where a buyout would most likely occur. Seems like over the next 30 days is a good time to add, bolt on options or even take some insurance with some 13 puts. Either way there is money to be made. A 10m short covering, coupled with some meme support should create quite the action. I am looking forward to it either way. I would give our chances 70-30 to the upside.
  • S
    Steve
    The news is out, and here we go. To the Moon, Alice. This will be a rocket ship.
  • T
    The real Onyxpig
    I posted this earlier but messed it up. HB 3259 received another cosponsor yesterday in Representative Kim Schrier from Omeros’s home state.
  • n
    noah
    For those of you that do not speak English, here is the chart :
    https://research.investors.com/stock-charts/nasdaq-omeros-corp-omer.htm?cht=pvc&type=daily
  • s
    syncnode
    Omeros’ narsoplimab to replace Alexion’s Soliris as go-to stem cell-associated TMA therapy, with broad clinical utility to lead to strong market traction, say experts.

    Old article on Narso but very informative!

    - High mortality and poor existing options result in widespread uptake
    - Soliris price point and some payer pushback make replacement ideal
    - Experts confident in approval given rare indication and Phase II results

    https://www.clinicaltrialsarena.com/comment/omeros-narsoplimab-to-replace-alexions-soliris-as-go-to-stem-cell-associated-tma-therapy-with-broad-clinical-utility/
    Omeros’ narsoplimab in HSCT-TMA will easily replace Alexion Pharmaceuticals’ Soliris as the current off-label standard of care when approved.
    Omeros’ narsoplimab in HSCT-TMA will easily replace Alexion Pharmaceuticals’ Soliris as the current off-label standard of care when approved.
    www.clinicaltrialsarena.com
  • s
    siserv2001
    Looks like not to many believe GD will finally nail this down. Someone needs to send him to a Tom Hopkins time management seminar! Amazed how shorts hit the stock just 32 total days before the PDUFA news hits.
  • B
    Billy Boy
    Could you imagine what life would be like if you had a blank check? Well, you kinda do, in a removed sort of way. The government raised the debt ceiling tonight to ride things out through December. Yay! We used our blank check. And we have a lot more of them in the check book! Yay!
  • b
    ben
    In case you missed it, 1. WO2021178902 - METHODS OF INHIBITING MASP-2 FOR THE TREATMENT AND/OR PREVENTION OF CORONAVIRUS-INDUCED ACUTE RESPIRATORY DISTRESS SYNDROME
  • T
    The real Onyxpig
    Don’t look now but 2 more Senators cosponsored S 586 to make 31 on 9/20 . HR 3259 just got 3 more to make 56 cosponsors. Could get done!
  • b
    ben
    Volume is light but since 2pm 9k traded and the price dropped 27 cents, just churning.
  • n
    noah
    Money flow is exploding to the upside and short position is down 4.29% !!! Buy all you can.
    https://www.wsj.com/market-data/quotes/OMER?mod=quote_search
  • s
    siserv2001
    The word of the day is Yartemlea. More later!
  • b
    bestpicks
    (EYEN) $4.50 -- 3 BIG Drugs in Pipeline 1 Drug with FDA Decision in October and another 2 Drugs in advanced Phase 3 trials = $20+ stock soon
    https://assets.wallstreet-online.de/_media/8763/board/20210727230519-screenshot-2021-07-27-at-23-04-33-powerpoint-pres.png

    +#+#+#
  • b
    ben
    One thing that is certain there will be cash raise before year end. How much and at what price unknown at this time.
  • B
    Billy Boy
    GD took the winds out of the sails with his incomplete BLA application. If you think the shareprice is going to run to over $20 prior to FDA response again, YOU are are sorely mistaken. just saying. GD has been the confidence destroyer.
  • M
    MR
    Pretty cool that the new base is forming at 16 with 2 major events coming up in the next 45 days around the Ispy and FDA approval. Those events will double the stock price in a massive short squeeze and more MM investment for a longer run move on the stock. Expect the 150m offering to be in the 27 dollar range very soon after the move. We have been seeing the short position being reduced over the last few weeks and watch what is happening in the options market for insurance and bolting onto positions. A 5-10B market cap is completely realistic. My only hope beyond all of this is Greg goes away. He really took us for a frustrating ride and made way too much money personally along the way.