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Celldex Therapeutics, Inc. (CLDX)

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2.38-0.02 (-0.83%)
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2.38 0.00 (0.00%)
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  • Short interest down another 800K shares as of July 14. Now at 13.7 million shares (11% of outstanding shares). Management and BOD were also issued almost 1.2 million options on 6/15 priced at 2.32. Expect to see continued short covering over the remaining summer as the price languishes at this level.

    Nivo/glemba solid tumor study added Wake Forest and George Washington University as study sites as of yesterday. Also added the IPD statement to that study as well.

    Hopefully we should hear an update on the suspended MUM study which has been suspended since June 4. Would think that all pts even those enrolled as of June 3 should have been assessed for evaluability by now; not sure why this hasn't been updated yet.

    Hoping for some update at quarterly CC the week of August 7 on what conferences they will be presenting at in the fall (?ESMO in early Sept).
  • Report: CD27 activation (target for varli) is associated with clearance of cancer cells in lymphomas and leukemias through NK cells. .Varli monotherapy produced the best result in varli Hodgkins lymphoma, with an end-stage patient undergoing a complete response. The patient is in full remission after 2 years of treatment of low dose Varli (0.3 mg/kg). CLDX went away from testing Varli in blood cancers, especially at lower doses- in the wake of this report, CLDX may want to consider revisiting Varli as monotherapy in lymphoma/leukemia pts:

    http://www.bloodjournal.org/content/130/3/297.long?sso-checked=true

    CD70 reverse signaling enhances NK cell function and immunosurveillance in CD27-expressing B-cell malignancies | Blood Journal
    www.bloodjournal.org
  • The Meditor Group investment fund, which initiated a new position in CLDX in the first quarter, reported on June 30 that it had purchased 1,650,000 additional shares of CLDX to increase its holdings to 5,800,000 shares. That fund hit the jackpot with EXEL and still maintains a very large EXEL position. It has very few companies in its portfolio.
  • RED....AGAIN. How do you spell SCAM?
  • The broader indices are kicking this bad, including the pharm ETF's, what a total embarassment.
  • Metric get fully enrolled yet?
  • On 7/17/17 CLDX amended METRIC PIII registrational trial in TNBC: added IPD statement (individual participant data sharing statement). Could be just a bureaucratic addition... or possibly a ray of hope?

    https://clinicaltrials.gov/ct2/show/NCT01997333?term=glembatumumab&rank=5

    Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer - Full Text View - ClinicalTrials.gov
    clinicaltrials.gov
  • VLTX half owned by LGND, and using LGND molecules for the hip fracture muscle retention study. Phase one results were very impressive, phase two is fully enrolled, results expected by Oct 18, 2017. Endocrine indications and results in indications like muscle wasting after non elective hip replacement or surgery. The rehab implacations of the tyroid based therapy is a one billion dollar market. This is a huge deal for morbidity, recovery and rehab, including lower post op expense metric. They have a pipeline as well, and the conjugate for fatty liver disease again, Tyroid based, is very interesting as well. Phase two will be in on that mid next year. I believe this sucker will be 6 -7 or more in a year. Disclosure, 15,000 @ ave 1.16.
  • KTOV = Mcap $16 Mil /Cash $17 Mil / O/S 10.6 M / NDA submission for potential Blockbuster this Quarter = 20++BAGGER ..ONE OF THE BIGGEST BIOTECH OPPORTUNITY EVER ! Thank me later guys

    Kitov Pharma (KTOV)

    Market Cap: $17 M
    Cash $17 M
    Price: $1.50

    Shares Out: 10.6 Million

    Kitov Pharmaceuticals Initiates NDA Filing for KIT-302 as a Treatment for Osteoarthritis and Hypertension
    https://baystreet.ca/articles/research_reports/lifesci/Kitov062717.pdf

    Kitov Expects to Submit an NDA for KIT-302 in the Third Quarter 2017.Kitov announced that it began the process of compiling the documents necessary to file an NDA for its lead asset KIT-302 as a treatment for patients who experience both osteoarthritis and hypertension. The Company hired Parexel International Corporation, a clinical research organization, to digitalize and formally submit its NDA application. Kitov expects the filing to occur during the third quarter of 2017, with a potential FDA approval during the second quarter of 2018.

    KIT-302 is a combination drug that treats osteoarthritis pain and hypertension simultaneously

    Primary efficacy endpoint achieved Lead drug candidate KIT-302 achieved its primary efficacy endpoint in a pivotal Phase III trial

    Marketing potential Pipeline candidates address large, multi-billion dollar markets

    Products

    Kitov’s current pipeline products, KIT-301 and KIT-302, are combination drugs that treat OA pain and HTN simultaneously. In December 2015, KIT-302 successfully achieved the primary efficacy endpoint for its Phase III clinical trial. In August 2016, the United States Patent Office issued a patent covering KIT-302.

    Market

    Of the 27 million Americans with OA, 50% also suffer from HTN, which is also a common side effect of stand-alone OA drugs. With no single medication currently treating both conditions, KIT-301 and KIT-302 are targeting this multi-billion dollar market.

  • They can't raise a dime on Wall Street, and what's left to dilute anyhow, zippo.

    They have to put themselves on the block and give the company away. Since no matter what, they can't continue, but hey, they have all kinds of useless employees and new board members to oversee a basic train wreck, my God, how awful and BS can a company get??? So, glemba has some efficacy, and BMS or whomever, scoops up the ashes for 5.50. They all walk away millionaires, and shares get the arce abuse. If you aren't in great companies, what should we expect. THIS COMPANY IS A TOTAL WASHOUT!!!!! STAY AWAY!!!!!
  • SMELLDEX is running out of Pesos folks, 139 million. They screwed WS once, they haven't a chance with another offering. Meanwhile, anything remotely positive won't be believe by anyone, unless, one of the participants decides to just scoop the company up for an acre of peanuts. If you don't see that, you deserve what you get here.
    Poor John, GBM. Too bad Rintega failed, really, really too bad.
  • Smellydex has a pooplyne not a pipeline......down again, oh my, what a huge surprise...NOT. This is a scam, they can't cure a hangnail, they stink, they lose money, capital and ruin investors portfolios.
  • Glemba will be pushed back yet again. far too many sites still recruiting. 176 sites 300 in total in study if you cannot get 2 patients per site its not a good sign. expect failure
  • John McCain diagnosed with glioblastoma
  • T U R D CITY and it's not pretty. What a total scam this is, no drugs, no profits, no products, no money in 3 qts, totally lost in the fog. Marisucki and crew, total con job. Glmeba, Vardi, are you GD serious, they couldn't cure a hangnail!!!
  • Metric study will fail. cash is running out fast. Varli going nowhere fast. Koltan was a big mistake as it brought in no revenues to sustain the company. AM will dilute more and when he can no longer as the pps is below $1 he will reverse split and try and do it all over again unless shareholders give him the boot./
  • Trades in a 2 cent range all day with under 1 million volume. pumpers will say that "it is finding a bottom". I say HELLO SCAM
  • so why are the majority of Metric Trial site listed as enrolling.
  • Glemba/Varli Study

    On Jen vs cancer blog post from 7/14 she unfortunately posts an update stating that she has progressed at about the 5 month mark (overall PFS in recent glemba study was 4.4 month median for all patients). From her posts there is no mention of rash so she likely is not in the rash subgroup and also it sounds from the posts that she didn't meet criteria for a PR (8cm to 6.8 cm).

    Unfortunately it looks like varli did not add much to Jen's therapy; her response was likely all glemba related. It is possible however that we may see a more pronounced ORR in those glemba/varl patients that do develop rash vs the 21% ORR presented in June. We will find out more this fall.

    Still awaiting enrollment completion of the glemba/CPI cohort 3 portion of the study; why is this 30 pt cohort taking so long to enroll?!? If I had CPI refractory MM I'd enroll immediately.

    My prayers are with Jen as she prepares to enter an IL-2 study and hopefully she will be one of those 5-15% patients who goes on to a CR. Best of luck Jen!
  • oh my, down .05 after hours. Pumpiedex is done folks, DONE.