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Nabriva Therapeutics plc (NBRV)

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0.5363-0.0237 (-4.23%)
As of 10:08AM EDT. Market open.
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  • C
    Charles
    NBRV’s Significant Pending Catalysts List
    NBRV has $213MM in incoming revenue already in the pipeline and that’s why we have an ultra conservative institutional investors like Fidelity Investments (aka) FMR holding 25.1MM NBRV shares. Smart money summary: Institutions hold 33% of float = BULLISH , Insiders added 58,250 shares net in August – BULLISH, and the Call-Put Ratio is at extreme BULLISH . Strong BUY $5 PT by Jan. 2021, 1 year PT $10+/sh.

    1. Strong MM$ revenue from EU, CA & US, especially on initial inventories from EU & Canada.
    2. Sivextro revenues will positively affect the quarterly/annual revenues
    3. FDA Type A Meeting results for Contepo will be announced. Ban on international flights have been lifted in the US. NDA will come next! FDA will likely prioritize this third NDA and get inspection done quickly.
    4. Partnership with MERCK provides an inside track for NBRV/MRK BO offer.
    5. Great Clinical News from NBRV’s pipeline is coming.
    6. Positive articles in widely read medical trade journals will be coming out for NBRV’s medications…CONTEPO already has approval for 9 indications already in Europe.
    7. One or more new EU marketing and distribution licensing and royalty for XENLETA contracts signed for - $50MM in new revenue.
    8. NBRV will regain compliance with minimum price of $1, no out of compliance warning.
    9. XENLETA will emerge as a major part of patient’s recovery from CV with CABP and NBRV will receive free media coverage as a result. Demand will ramp up for XENLETA!
    10. NBRV will receive a major grant for clinical trials of XENLETA vs. drug resistant STD.
    11. CHINA APPROVES XENLETA for marketing & distribution = $85MM milestone revenue!
    12. Australia reviews and APPROVES XENLETA = another MM$ contract for M&D.
    13. NBRV gets MM$ grant money from an international Antibiotic Initiative Organization.
    14. NBRV’s share price continues, 20-day SMA crosses over 50-day SMA = Bullish Trader Alert
    15. NBRV share price rises above $1 as now institutions, MF and ETF’s start making LARGE buys.
    16. Fall cold and Flu season starts in Sept. and XENLETA receives glowing expert endorsements since it has been proven to reduce inflammation and to help CV patients with CABP.
    17. Analyst’s upgrade NBRV from HOLD to BUY to STRONG BUY.
    18. XENLETA sales surprise in 3rd quarter report from the use replacement for out of stock Rx meds.
    19. Mass media’s CV fear campaign starts in the Fall = increased demand for XENLETA
    20. All remaining “shorts” must buy to cover after margin calls due to NBRV’s rapid rise
    21. CONTEPO will be FDA approved in US and stock price rises above $12 a sh.
    22. Q4 sales & EPS beat expectations. NBRV becomes global ANTIBIOTIC EMPIRE with 3 best in class antibiotics and there is more in the pipeline.
    23. NBRV will be featured as a hidden gem in a list of oversold stocks to buy now.
    24. NBRV will file a NDA for XENLETA for 2 new indications including a major STD.
    25. NBRV will become #1 on the list for the largest volume and largest percentage increases in price, a list used for traders.
  • C
    Charles
    NBRV GREAT NEWS ON US STRATEGIC STOCKPILE SELECTION IS IN THE CARDS... "The National Institute for Allergy and Infectious Diseases (NIAID) has identified that secondary bacterial pneumonia caused by common upper respiratory tract bacteria plays a predominant role in the cause of death in pandemic influenza and recommends that the prevention, diagnosis, prophylaxis, and treatment of secondary bacterial pneumonia, as well as the stockpiling of antibiotics and bacterial vaccines, be high priorities for pandemic planning. We believe there is a potential for XENLETA to be considered for U.S. government stockpiling for pandemic influenza."
  • M
    Marjan
    Johnson & Johnson vaccine enters phase 3 and buying NBRV as a strawberry on the cake.
  • J
    Jason
    According to analysts' consensus price target of $3.30, Nabriva Therapeutics has a forecasted upside of 481.5% from its current price of $0.57.
  • C
    Charles
    Pharma companies are creating a new $1 billion fund to acquire or invest in small antibiotic companies

    Big Pharma exited from the antibiotics space one by one. And now they may be coming back together.
    Pfizer, Eli Lilly, Novo Nordisk, Boehringer Ingelheim, Bayer Pharmaceuticals, Merck KGaA and the American Merck — one of the last giants standing — are teaming up to create a $1 billion for-profit venture to bet on small biotechs developing mid-stage antibiotics, Ed Silverman reported for STAT.

    Government officials from Germany, Sweden, France and the UK, as well as representatives from Wellcome Trust and Pew Charitable Trusts, will join the companies to announce the initiative on July 9, Silverman wrote. The World Health Organization and the European Investment Bank are also involved in what is being billed as a new solution to the “antibiotic innovation challenge.”
    As concerns about antibiotic resistance loom ever larger, though, the effort itself may count. “The thinking is that, ideally, if they put money in [the fund], this will serve them in the long run, but also make them look good,” reads a key quote. “They got pretty bad press when they walked out on antibiotics.”
    Madam Therapeutics welcomes this very important initiative, and believes this is another sign that pharma and investors are getting back in the field.
    Be one of them…..NBRV and MRK….all the signs are there…all you have to do is act on them…

    ........Three things cannot long be hidden: The Sun, the Moon and the Truth......

    The ultra-reliable smart money indicator, a call-put ratio, is still EXTREMELY BULLISH for NBRV.·
  • J
    Jean
    Will the NTAP starting 10/1 make a difference in the market's valuation of NBRV?
  • N
    Nabr
    Northland sees peak global sales of Nabriva's Xenleta at $1B
  • C
    Charles
    NBRV has two FDA approved medications to sell already. Third approval is already in works for Contepo. We just had a 3 bar reversal chart pattern materialize, has $130MM in the pipeline already, just received a pay raise from Medicare/Medicaid on XENLETA & Contepo , China's Xenleta approval to be expedited news is coming, initial inventories for Xenleta in 29 countries coming, news on XENLETA vs. CV with CABP coming, selection for National Strategic Reserve (US) news likely to be announced soon with huge MMS buy and MM$ antibiotic manufacturing grant award in the pipeline. Huge Great News Drop Last Monday so all evil SS will have to flee and fuel our rocket. We have soooo much to look forward to...stick around for it! When the FUND owners begin to push the stock price higher, shorts better look out above!
  • C
    Charles
    CMS Grants NTAP For Nabriva Therapeutics PLC (NASDAQ:NBRV)’s XENLETA For Injection
    By Gavins Felicity -September 23, 2020

    CMS (Centers for Medicare & Medicaid Services) issued NTAP (new technology add on payment) for Nabriva Therapeutics PLC (NASDAQ:NBRV)’s XENLETA. NTAP is used for XENLETA injection for an inpatient setting in a hospital.

    XENLETA to treat CABP
    Pleuromutilin antibacterial – Xenleta is used for the treatment of adults with CABP (community-acquired bacterial pneumonia). The fast track designation and QIDP (Qualified Infectious Disease Product) for Xenleta’s IV and oral formulations are approved by the US Food and Drug Administration.

    Nabriva will qualify for additional payment
    Nabriva will receive an additional payment of $1,275.75 from CMS when Xenleta is used in an inpatient setting for 2021 with effect from October 1, 2020. In August 2019, the Food and Drug Administration approved Xenleta to cure patients with CABP.

    Nabriva receives NTAP for fosfomycin
    Nabriva received NTAP for fosfomycin (Contepo) from CMS. Fosfomycin also received fast track designation and QIDP from the US FDA to cure cUTI (complicated urinary tract infections). It can also cure acute pyelonephritis. CMS will pay $2,343.75 in 2021 if the US FDA gives its nod for fosfomycin before July 1, 2021, for each case in a hospital inpatient setting.

    What is the benefit for hospitals?
    The hospitals engaged in providing treatment using Xenleta will also get additional payment with NTAP in addition to the standard of care DRG (Diagnostic Related Group). Additional payment will help the hospitals compensate for the cost incurred to buy new devices and drugs to satisfy certain criteria.

    Additional payments for the QIDPs will be capped at 75% of the product’s average cost in 2021. NTAP designation is valid for up to 3 years for the specific indication. Ted Schroeder, CEO of Nabriva, said the new technology add-on payment designation demonstrates XENLETA and fosfomycin potential in addressing the immediate need for first in class and novel antibiotics the people who are fighting against the drug-resistant infections.

    The therapeutics team of Nabriva formulated semi-synthetic pleuromutilin antibiotic – XENLETA. The drug is used for systemic administration on humans and prevents bacterial protein synthesis. Nabriva demonstrated the effectiveness of XENLETA in multinational, two multicenter, double-dummy, double-blind, and non-inferiority trials conducted on 1,289 people who are suffering from CABP. The side effects of XENLETA are nausea, diarrhea, elevated liver enzymes, reaction at the injected site, and vomiting.
  • C
    Chris
    Merck partnership, big tute ownership most likely up to 40% of the float. Already analyst are predicting sales increase this quarter. Plus 85M milestone payments from China which is now on fast track designation. 100M from this fund coming soon. https://madam-therapeutics.com/index.php/2020/06/30/pharma-companies-are-creating-a-new-1-billion-fund-to-acquire-or-invest-in-small-antibiotic-companies/ This is a European fund, that will be giving funds to European companies. If they R/S with a influx of this cash we'll be 30$ a share with a very very small float.
  • Y
    YoDaddyNow
    -NTAP designation highlights need for novel antibiotics to fight drug-resistant infections and advance antimicrobial stewardship -CONTEPO first Qualified...
    -NTAP designation highlights need for novel antibiotics to fight drug-resistant infections and advance antimicrobial stewardship -CONTEPO first Qualified...
    www.globenewswire.com
  • C
    Chris
    There’s no other antibiotic that has anti inflammation properties like Xenleta, just wait till that gets traction.
  • Y
    Yatish
    Just granted new technology add-on payment for xenleta and contepo by CMS. it's on company's press release.
  • C
    Charles
    NBRV Let's review NBRV's $230MM in incoming revenues again, so you understand how oversold NBRV really is... ~$50MM from EU licensing deals for XENLETA (soon) $85MM from China's approval of XENLETA (soon) $10-$15MM from EU's initial inventories (soon) $5MM from Canada's initial inventories (soon) $10MM from China's initial inventories (soon) $10MM from US revenues for XENLETA, Sivextro (antibiotic resistance is a global plague & cold & flu season is here with record cold/snow winter in north central US). $50MM from Antibiotic Manufacturer Stimulus Fund $10MM from likely selection to US Strategic Stockpile (XENLETA) by federal government (NTAP confirmed) $25MM grant likely to facilitate XENLETA's clinical trials vs. STD. ***These dirt cheap prices in NBRV & $GNUS are a GOLDEN OPPORTUNITY for investors because we have a boatload of catalysts pending for NBRV! I just added at .5410. I’ll open the present at Christmas :>).
  • J
    Jason
    What’s a realistic pt by the end of the year? Looks like some good upcoming catalysts with not much downside here. Would 1.50-3 be the range?
  • C
    Charles
    $NBRV has just solved its biggest problem. Undisputable facts: The future is EXTREMELY BRIGHT for NBRV shareholders revenue wise. We will see ~$50MM coming from EU licensing deals, ~$5-6MM coming from EU & CA initial inventories, $85MM coming from China's XENLETA approval soon, $8-10MM coming from China's initial inventories, cold & flu season in USA = ~$5MM
    in revenue, XENLETA selected for National Strategic Reserve = $10MM
    , Sivextro sales $$$ and $50MM grant award coming from Antibiotic Manufacturers' Stimulus Funds. FYI countries with government health care will not hesitate to stock up on XENLETA. Total new revenue incoming = $213MM
    Hmm, why did Fidelity Investments, our #1 institutional owner invest 25.1MM in NBRV? Why is NBRV's institutional ownership jump up so high? Hmm, why did insiders buy 58,250 shares net in August? Did you know a 3 bar reversal pattern is the #1 most profitable chart pattern for swing traders?
  • T
    T
    Why do the company add Contepo to the granted new technology when FDA is not approved yet?? The NBRV knows for sure that Contepo will be approved????
  • m
    mondooraculo
    Are you guys {investors in NBRV} awake yet? Fidelity investment; Shelf registration; European approval for XENLETA; Soon FDA approval; Entering China; Merk deal; This road to $$$$ is paved with gold, all you have to do is stay the course. Bashers, worry warts and shorters go somewhere else.
  • A
    Asghar
    Good and inspiring presentation
  • C
    Charles
    Bullish Trend Analysis 9/17/20
    The RSI Indicator points to a transition from a downward trend to an upward trend -- in cases where NBRV's RSI Indicator exited the oversold zone, 29 of 36 resulted in an increase in price. Tickeron's analysis proposes that the odds of a continued upward trend are 81%.

    The Stochastic Indicator suggests the stock price trend may be in a reversal from a downward trend to an upward trend. 51 of 73 cases where NBRV's Stochastic Oscillator exited the oversold zone resulted in an increase in price. Tickeron's analysis proposes that the odds of a continued upward trend are 81%.

    The Momentum Indicator moved above the 0 level on September 17, 2020. You may want to consider a long position or call options on NBRV as a result. In 70 of 99 past instances where the momentum indicator moved above 0, the stock continued to climb. The odds of a continued upward trend are 71%.

    The Moving Average Convergence Divergence (MACD) for NBRV just turned positive on September 14, 2020. Looking at past instances where NBRV's MACD turned positive, the stock continued to rise in 28 of 40 cases over the following month. The odds of a continued upward trend are 70%.

    Following a +2.56% 3-day Advance, the price is estimated to grow further. Considering data from situations where NBRV advanced for three days, in 189 of 251 cases, the price rose further within the following month. The odds of a continued upward trend are 75%.