U.S. Markets open in 54 mins.

Insmed Incorporated (INSM)

NasdaqGS - NasdaqGS Delayed Price. Currency in USD
Add to watchlist
28.29+0.66 (+2.39%)
At close: 4:00PM EDT

28.15 -0.14 (-0.49%)
Pre-Market: 7:22AM EDT

People also watch
GNVCIMMUCRISBCRXIMGN
  • K
    Kinky
    Kinky
    deleted from this morning
    zake1 wants to know why we have not heard from Insmed regarding this ! ! \ \ "SERIOUSLY! \ \ Re: Shire Receives FDA Fast Track Designation for SHP607 for the Prevention of Chronic Lung Disease in Extremely Premature Infants\
    ITS NOT INSMEDS \ \ \ ITS SHIRES ! DUHHHHHHHhhhh
  • K
    Kinky
    Kinky
    ALL FALSE ! ZAKE! is lying \ There is a whole lot more here than I remember...first of all..these are some of the issues Iplex was approved for, and found safe...think of all the people that suffered because of this
    1.54 “Named Patient Indications” means myotonic muscular dystrophy, HIV related Adipose Redistribution Syndrome (HARS), retinopathy of prematurity, recovery from burns and trauma, and recovery from hip fracture.
  • l
    linda
    linda
    my post from yesterday on filing protocol was deleted
  • l
    linda
    linda
    Anyone commenting about possible revenues in Q1 2018 immediately show they do not have any understanding of the issues at hand.
  • K
    Kinky
    Kinky
    John Dsouza \ " as they provide further updates on data and recent submission" FALSE\ GO BACK TO INVESTOR VILLAGE
    THERE WAS NO SUBMISSION
  • J
    Joe Blow
    Joe Blow
    SEC Insider SHAROKY MELVIN MD sold 50,000 shares
  • E
    Endo
    Endo
    Kinkys taunts aside Why would this board be hyping iplex and Shire?This is not relevant to shareholders of INSM
    Why would Insmed spend money when they have a proven technology in Arikayce
  • K
    Kinky
    Kinky
    Why Investor village is dangerous.zake asks the "Piano master" to opine on something he then makes up a story and longtime stupid "JAD9000" chimes in JAD9000 . I agree with prior posts that we should be selling in the US by Q1, 2018."
    It is important to realize that all these posters are simply making up stories without substance.Laugh at the $50 dollars soon but the timeline in anyones investment should be important and simply put these people are lying STAY THERE!
  • J
    John Dsouza
    John Dsouza
    This will bounce between $28 and $31 for a few weeks and then will surpass mid 30s as they provide further updates on data and recent submission. I suspect when we get Fast Track news it'll spike to mid 30s plus. Nothing wrong in taking profits from trading shares but most people are probably not touching their core shares!
  • m
    mark
    mark

    http://www.smarteranalyst.com/2017/09/11/cowen-sees-high-80-probability-fda-approval-insmed-incorporateds-insm-ntm-drug/

    Cowen Sees High 80% Probability of FDA Approval for Insmed Incorporated’s (INSM) NTM Drug
    Insmed's lead asset ALIS poses compelling prospects for commercial success in the U.S., says top analyst.
    www.smarteranalyst.com
  • J
    Jay
    Jay
    It seems that shorting is starting now and we will see how low it will go. Any comment?
  • l
    linda
    linda
    "Jay" Here are some "facts" .The clinical trial follow up will take 2 years but the 6 month data is the FDA endpoint. Insmed plans to file.29% is a good number of patients to be CURED. Nothing else comes close.Your 71% is misleading since 71% of NTM patients will not use the drug. Arikayce will be for refractory patients only.{meaning only who fail antibiotics completely)The only one misleading is you because it is clear you do not understand Arikayce
  • J
    Jessica
    Jessica

    The trading setup for INSM looks very enticing. I started receiving notifications from https://hotstocks123.blogspot.com the other week and so far they have presented interesting new trade ideas.

    Hot Stocks
    hotstocks123.blogspot.com
  • K
    Kaitlyn
    Kaitlyn
    Is INSM overvalued at current levels? This is so frustrating trying to find trade ideas. I've subscribed to some email newsletters which helps me with new stock ideas. awe*some*sto-cks is the one i like best.
  • D
    Dan
    Dan
    Seems like it is headed lower. A few more days than I thought. Profit taking soon when it starts below $24
  • L
    L
    L
    Glad I went back to the short side yesterday!! Ouch for those that are long.
  • J
    Joe West
    Joe West
    How long to file review approval and Launch? Serious relies only
  • F
    Fghyujk Sdfghj
    Fghyujk Sdfghj
    # Terry just prognosticated the INSM low.#also sent a nice note last night I asked if I can repost #lunchtime #go away Jose#
  • M
    Michael
    Michael
    Could we see a far higher share price by the end of the year?

    Quotes from Dr. Kevin Winthrop's observations about MAC therapy during the Investor Day event (not necessarily in this order) -

    None of the first-line drugs are approved.

    NB: The regimen for standard infection is a Macrolide / Rifampin / Ethambutol triple combo.

    Most of my patients can't tolerate all three. Almost no-one likes Rifampin. Rifampin reacts with about thirty different drugs out there if I had to guess - a lot of the medicines people are on. It's a very difficult drug to use.

    And there's a lot of older people particularly who do not tolerate it.

    NB: Common side effects of Rifampin include nausea, vomiting and diarrhea.

    Even if we start with the three drugs I mentioned we quickly lose one or more of them in a large percentage of individuals. Which leaves a hole in the regimen.

    The drugs are there to protect themselves. M.Avium is highly drug-resistant. We treat with multidrugs to diminish the chance that the bugs get resistant to these antibiotics.

    For cavitary disease we add amikacin. IV amikacin is probably the most potent drug we have, it's just people can't tolerate more than a couple of months through IV. It's just too toxic.

    We'd all be interested to see if ALIS would be useful in the first-line therapy for all these patients. I could see using a drug like this right away in a lot of patients - in fact in most patients.

    NB: Immediate clarification by Will Lewis - Those are decisions a physician will make. (Promotion of off-label use is prohibited).

    ---------------

    Will the Payers approve the off-label use of ALIS in place of the off-label use of Rifampin in the standard regimen?

    Improved compliance / greater efficacy = earlier eradication of the infection = shorter duration of therapy = reduction in overall cost of therapy.

    The duration of therapy for the standard MAC regimen ranges from eighteen to twenty-four months. As ALIS delivers concentrated amikacin directly to the site of the infection, the Payers will surely be alive to the possibility of a duration of therapy much closer to the six months recommended for the standard Tuberculosis regimen.

    Furthermore - as up to 33% of patients currently die within five years of diagnosis of MAC infection, it's clearly in the Payers' interests to prolong their lifespan so that the Payers receive more in Plan payments.

    From the Investor Day slides -

    ..... Estimated 65,000 - 80,000 people in the US with lung disease caused by MAC, 60% of whom will be treated.

    ..... Estimated 25% - 30% non-responders to the standard regimen.

    The ultra-conservative estimate is an initial 9,750 treated patients (65,000 x 60% x 25%) in the US for whom ALIS now seems highly likely to be an FDA-approved therapy.

    If Insmed is supplying ALIS to 10,000 patients by the end of 2019, a conservative price of $75,000 pa will generate sales of $750 million.

    The average biotech valuation sales multiple is currently 5.67 - $4,252,500,000.

    $4,252,500,000 divided by 77 million shares would mean a share price of $55.23 by the end of 2019 - consistent with the 2017 Offering price of $28.50.

    ---------------

    So is there any reason for fund managers and other professional investors to pay more than $28.50 this year?

    The answer lies in their private valuation, the basis of which is usually anticipated earnings over the first TEN years of sales.

    In addition to the immediate off-label use of ALIS contemplated by Dr. Winthrop, the professional investors will also expect ALIS to be used off-label for infections in Non-CF Bronchiectasis other than MAC infection.

    Recent estimates indicate a minimum of 170,000 people in the US with this condition, and there are no approved antibiotics. A large proportion of those people may be included in the estimates of MAC infection.

    Looking further ahead, Insmed's inhaled liposome delivery technology could be a game changer in the war against Tuberculosis.

    From the World Health Organisation -

    Ending the TB epidemic by 2030 is among the health targets of the newly adopted Sustainable Development Goals (SGD). To sustain progress beyond 2025 and achieve the SDG 2030 and End TB 2035 targets, additional tools must be available by 2025.

    In particular, a new vaccine that is effective pre- and post-exposure and a safer and more effective treatment for latent TB infection are needed to reduce the number of new TB cases arising from the approximately 2 billion people worldwide who are infected with M.tuberculosis, as well as better diagnostics and safer and easier treatment including shorter drug regimens for TB disease.

    ---------------

    1. Safer and easier treatment including shorter drug regimens for TB disease by 2025 -

    In 2015, 10.4 million people fell ill with TB and 1.8 million died from the disease.

    The current four-drug regimen for standard (non-resistant) TB is based on two main drugs - Isoniazid and Rifampin, taken for six months - in combination with Ethambutol and Pyrazinamide for the first two months.

    The Rifampin side effects are a major problem in TB management. Sub-optimal levels of antibiotic promote antibiotic resistance.

    In 2015, 480,000 people developed TB resistant to both Isoniazid and Rifampin. A further 100,000 people required treatment for Rifampin-resistant TB.

    The recommended regimens must include one of the following injectable antibiotics: Amikacin, or Capreomycin, or Kanamycin - all of which are very toxic.

    ---------------

    2. Safer and more effective treatment for latent TB infection by 2025 -

    An estimated two billion people are carrying latent TB infection. TB will remain a serious threat to public health for as long as there is a single person on the planet walking around with latent infection.

    The Centers for Disease Control and Prevention (CDC) website lists four recommended regimens for latent infection - one of which is Rifampin monotherapy, once daily for four months. As people with latent infection don't suffer any symptoms, are those regimens administered at gunpoint?

    The site also warns -

    [ Due to the reports of severe liver injury and deaths, CDC recommends that the combination of rifampin (RIF) and pyrazinamide (PZA) should not be offered for the treatment of latent TB infection. ]

    But the recommended regimen for ten million people each year who get normal TB infection includes both of these drugs for the initial two months. There are no safer alternatives.

    ---------------

    Replacing Rifampin with ALIS in the standard regimen would be safer - and would reduce the incidence of drug-resistant TB, which is far more difficult and expensive to treat. Only 52% of patients are successfully treated.

    Therefore replacing the injectable antibiotic with ALIS in the drug-resistant regimen seems a no-brainer, especially given Dr. Winthrop's comment about the toxicity of IV amikacin.

    However 95% of TB infection occurs in low and middle-income countries, where the cost of ALIS is likely to be prohibitive in 2019. But one would expect a substantial increase in the funding of TB management long before 2029.

    Avoidance of toxicity would not be the only advantage of inhaled liposome delivery of TB antibiotics. An individual whose sputum no longer contains live mycobacteria after a few months is an individual who can no longer fuel the epidemic.

    None of this will be news to the professional investors. Their estimates of Insmed's earnings over the next ten years would be of no value unless they included revenue other than that anticipated from the initial approved use of ALIS.

    The higher those estimates, the more they will be prepared to pay for the shares this year.
  • J
    Jay
    Jay
    Warning! GuruFocus has detected 2 Warning Signs with INSM. Has anyone read the report?