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Keryx Biopharmaceuticals, Inc. (KERX)

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6.73-0.17 (-2.46%)
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  • O
    Outrage240
    Outrage240
    Consonance Capital- 7,000,000+ new shares @ 6/31
  • c
    crazitjo
    crazitjo
    Steve Cohen's Point72 Asset Mgmt....Increases their KERX holdings by 1,452.700.....Now holds 1.552,700.....
  • k
    kenneth
    kenneth
    Moving right in line with the index in the absence of news
  • A
    Albert
    Albert
    Every day I come to yahoo finance I think yahoo is looking more and more like a SJW site. Just a matter of time and I will find a different place for my info on stocks.

    Bet even the SJW's are irritated. Since they wont be able to agree on what bothers them the most or hurt their feelings today.

    And Otiv stock on here is really badly ran over with sjw's.

    Thinking I will be finding a new home for info
  • E
    Enzrpaide
    Enzrpaide
    Chart is going positive for next leg up, according to foxchart. Looking for breakout at 7.59.
  • L
    Longnerx
    Longnerx
    How many times are we going to crossover 6.66. let us now see 7.77 and on our way to 10's and 20's. Tired of back and forth of this stock . lots of manipulation going on.
  • g
    gerald
    gerald
    Can someone give a good theory as to why there are over 800 Aug 8 puts bought? Just a Hedge for a bigger short position?
  • E
    Elvis
    Elvis
    what the hell is this PR department doing- this stock should be at $8 drifting to $10. Nothing but good news.
  • R
    Richard
    Richard
    Bought 190 August 7 calls the last few days. Drinks are on me at the end of the week.
  • B
    Bert
    Bert
    A reasonable and great comment from jborowy
    at SA "Keryx Biopharmaceuticals: Catalyst In Upcoming FDA Decision"
    by Emerging Equities

    I think people tend to overlook a big factor with Keryx. That is this: all phosphate binders have high percentages of people that cannot tolerate them, primarily due to the gastrointestinal problems they cause. Renvela, the current market leader, is effective but many people have severe constipation, nausea, etc... Auryxia, in trials has had half of the amount of people that get off of it because of tolerance issues, as compared with Renvela. This single factor could propel it past Renvela as the market leader. But it will take time to gain that kind of traction and reputation with nephrologists.
    Plus, since it has absorbable iron, dialysis companies such as Davita, will likely push nephrologists to prescribe it vs. others to cut down on their IV iron which they must supplement as needed to patients. IV Iron is included in their bundle reimbursement from Medicare (meaning, it's a direct variable cost that can be reduced with patients taking Auryxia vs. any other binder). I suspect it will take a year or more for them to fly this flag because they will have to see consistently that patients taking Auryxia require less or none at all IV Iron.
    The single biggest hurdle for Auryxia right now is that it is new and so many nephrologists are content to prescribe the trusted and true Phos-lo (which they prefer to start with since it's generic) and Renvela (which is effective and has a long track record). However, as more research shows that calcium-based binders have long term cardiovascular implications, I think more and more nephrologists will default to non-calcium binders such as Renvela and Auryxia. There are other binders but they all have massive downsides such as major gastrointestinal tolerance issues, or unknown liver risks such as with fosrenol, which is a heavy metal.
    All in all, I think Auryxia has a good chance of becoming the market leader over the course of 5 years or so on the basis of efficacy and tolerance. It can also directly reduce costs for dialysis companies by reducing or eliminating need for IV Iron in patients taking Auryxia, and history has proven they will go to any lengths to increase bottom line (google previous Davita lawsuits and settlements). These factors combined with the IDA potential make this a potential home run buy, though not a certain one. But in the $6 range, I think even worst-case scenarios are really not too shabby, so it's got a good risk-reward ratio. That's my two cents.
  • K
    Kevin
    Kevin
    According to RealTime Dynamix™: Bone and Mineral Metabolism, a quarterly report published by Spherix Global Insights, the migration to non-calcium based binders, with accelerated adoption of Keryx's Auryxia and FMC's Velphoro, is expected to continue

    EXTON, Pa., Aug. 10, 2017 /PRNewswire/ -- Since the introduction of Renagel by Genzyme Corporation nearly 20 years ago, the use of non-calcium binders has been steadily gaining ground, buoyed by clinical data as well as heavy promotion by companies with non-calcium based phosphate binders. Recently, KDIGO published updates to the Clinical Practice Guidelines for CKD-MBD with two standout recommendations that may shift practice patterns. These include:

    In adult patients with CKD G3a-G5D receiving phosphate-lowering treatment, we suggest restricting the dose of calcium-based phosphate binders

    In adult patients with CKD G3a-G5 not on dialysis, we suggest calcitriol and vitamin D analogs not be routinely used. It is reasonable to reserve the use of calcitriol and vitamin D analogs for patients with CKD G4-G5 with severe and progressive hyperparathyroidism
    Invest In Intelligence That Delivers

    Regarding the recommendation for avoidance of calcium based binders, more than 94% of surveyed nephrologists (n=192) use calcium based binders in hemodialysis patients, and more than one-third report a preference for calcium binders as first-line binders for dialysis patients. An even higher percentage prefer calcium binders as first line options for the pre-dialysis population. Over time, share has gradually shifted to non-calcium agents, dominated by Sanofi-Genzyme's Renvela. However, nephrologists estimate that more than one-third of their hemodialysis patients are still treated with calcium agents and overall, at any given time, close to 40% are above target for phosphorus. Future projections for non-calcium binders show significant share gains for Auryxia and Velphoro at the expense of calcium-based binders and Renvela in the next six months - a trend which could be further fueled by the KDIGO update.

    According to Dr. Geoffrey Block, a recognized expert in CKD-MBD and a member of the KDIGO workgroup for the updated Clinical Practice Guidelines, "With regard to P lowering therapy the new CPG update now recommends that the use of calcium containing phosphate binders (CCPB) be restricted- with no caveats or limitations. This recommendation is the result of new data published since the 2009 Guidelines which demonstrate several important findings: 1) patients with CKD are in positive calcium balance (over the short term) with even modest doses of CCPB 2) RCT's evaluating patient level outcomes which compare CCPB to non-CCPB demonstrate that use of the non-CCPB sevelamer resulted in reduced progression of CKD to RRT, reduced CV events and reduced mortality, while CCPB accelerated arterial calcification in a study in patients in CKD stages 3b-4, and 3) several recent meta-analyses demonstrate an increased risk of mortality with CCPB as compared to non-CCPB in patients with dialysis-dependent and non-dialysis dependent CKD. There is no data from RCT's to assess whether or not there is a 'safe' dose of calcium and how CCPB could be useful in moderate doses in combination therapies with non-CCPB, and thus no guidance can be provided as to specific limitations on total daily dose of elemental calcium. As a result, the workgroup chose a more general recommendation to restrict the use of calcium based P binders, but still did not suggest to completely avoid them. This represents an important change in paradigm for providers who manage patients with CKD who are in need of phosphate lowering therapy."
  • L
    L
    L
    Long time waiting... after the "death" of P (and licked my cuts from AEZS), I doubled down on KERX shares at $1.50, rode that through the FDA decision, sold 1/3 at 6ish on day 1, 2/3s at 17ish. Waited for the drop - started buying back (started too early) and kept buying. rolled most of my profits into another 2 BIOs - one was bought out and now the other has panned out. Ready for this NDA to pan out and keep moving into more high yield stocks as protection like I have been for the past year (and SKX) since I'm questioning this current market. This has been a long journey and I will be sad when it ends, but relieved in another way... Good luck to all of the truly long LONGs, many of whom where around well before even me. PHISH
  • B
    Bert
    Bert

    Some words, thoughts and facts to the Citizen Petition

    First of all i´m an long term investor and if my memory is correct Ron Bentsur former CEO of Keryx had discussed Keryx´s possibilities to approve Zerenex (now Auryxia) for CKD in non-dialysis patents. He said in a CC in late 2014 WE (Keryx) only need a phase 3 trial with 200 - 250 patients. The study design of this p3 trial was coordinated with the FDA

    "We showed statistically significant results along all those parameters, and our phase 3 study; which is pending commencement, we expect to start that this month, so in the next couple of weeks, we will be looking at hemoglobin as the primary endpoint. This will be a pivotal study; if we succeed with this study, we believe that we will be able to file an FN DA for label extension to go into pre-dialysis. We are going to target enrollment of 230 patients, at stages 3 to 5 chronic kidney disease with iron deficiency anemia. The primary endpoint, as I mentioned before, is hemoglobin. At week 16, there’s going to be a two month safety follow up, so all together, a six month program. This is something we’re doing with the hematology division within the FDA, so we filed an IND within that division and that’s going to be routed through that division. In terms of the international expansion, we talked about the Japanese approval that occurred earlier this year and the launch that occurred a few months ago."
    from https://tex.org/ferric-citrate-drug-of-choice-ckd-dialysis-patients/

    2nd point: Early march 2017 FDA accepted the application for a SNDA for IDA in non-dialysis
    http://www.reuters.com/article/brief-keryx-says-fda-accepts-application-idUSASB0B4CW

    The FDA grant reviews of NDA/SNDA etc. only if the submitted data are COMPLETE to access the application.
    Thats means WITHOUT safety data the FDA had rejected the application.

    Here is the petition
    https://www.regulations.gov/docket?D=FDA-2017-P-4334

    And there are several responses from the FDA to this petition.

    https://www.regulations.gov/document?D=FDA-2017-P-4334-0039

    and many others, means 37 responses to Sidney Austin LLP, the Fresenius lawyers

    My interpretation is the chance that FDA grants this petition somwhere between minimal to impossible.
    From my point of view Fresenius Lawyers compain about a form error of the FDA. From Lawyers perspective FDA has granted a review of sNDA application without a safety study.
    The tried to find a construct to prevent a partial market loss of Fresenius flag ships VENOFER and INJECTAFER (billion of dollars)
    Iron overload itself is not the issue because Fresenius flag ships already have the warning. Its about winning time to force an additional phase 3.

    from my point of view its a very good sign that FDA responded to Fresenius and not to Keryx

    frank

    Will Ferric Citrate (By Keryx) Become The Drug Of Choice For CKD/Dialysis Patients? | Tex Dot Org
    Ferric citrate will soon by used widely for hyperphosphotemia and helps replenish iron stores in dialysis patients. Keryx CEO explains why.
    tex.org
  • R
    Richard
    Richard
    I have a bid in for 500 $7 August calls at $.01. C'mon shorts, take my free $500.
  • z
    zippynj
    zippynj
    just another day of jerking the SP ariund at the start. while voline may not be much the trend is positive.
  • r
    retatbch
    retatbch
    IMS 1013 per JD2 on Stock Twits;
  • A
    Alfredo
    Alfredo
    Companies Reporting as of 08/09/17 (Source NASDQ)
    Rice Hall, James Shares Held 1,666,934 Change +326,285
    Bank of New York/Mellon Shares Held 963,054 Change +32,687
    Schaw Shares Held Shares Held 441,106 Change +4,388
    Rhenman Partners Shares Held 425,111 Change 0
    Monarch Partners Shares Held 423,111 Change +423,160 ( New)
    Boston Partners Shares Held 409,051 Change 0
    Chicago Equity Shares Held 381,205 Change +385,205 (New)
    Blair William Shares Held 141,200 Change +141,200 (New)
    Sis National Shares Held 130,500 Change 0
    Note: All the companies reporting as of 08/09/2017 added 1,308,921 share. NONE SOLD
  • B
    Bert
    Bert
    johndonaldtoo
    $KERX IMS 1013

    from Stocktwits
  • Y
    Yoshka
    Yoshka
    $6.66........remember dat? lol
  • B
    Bert
    Bert
    From stocktwits

    BDeepAndThrusting
    $KERX $969k vs $958k last week for Symphony

    hard to determine exact IMS scripts

    but as a reference point
    we had the worse factor of nearly 1,04 means 1003 IMS with 958 $symph scripts

    The best ratio is 1,17
    and a typical ratio 1,1

    that means IMS are between 1008 and 1134
    IMS most likely between 1060 and 1070

    lets see