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?
Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer - Full Text View - ClinicalTrials.gov
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.
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 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
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.
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.
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!
It seems that Celldex keeps looking for the home run. A couple of minor victories would help in keeping them solvent and improved their reputation. I'm a recent buyer so my costs are low. Right now, I don't understand institutional interest.
The board seems to share this opinion. I am searching for a reasonable answer - one which has not come from management. Will the next webcast give an explanation? I think shareholders could ask more pointed questions! I am listening.
John McCain diagnosed with glioblastoma
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.
Another article showing that GPNMB is linked to breast cancer invasiveness.
Aduro Announces Milestone Achieved Relating to Collaboration with Merck for Development of Anti-CD27 Antibody for the Treatment of Cancer
BERKELEY, Calif., July 13, 2017-- Aduro Biotech, Inc., a biopharmaceutical company with three distinct immunotherapy technologies, announced today that the company has earned a $2.0 million milestone payment ...
Pumpies using sympathy stories like the McCain story like they did with Joe Biden son a couple years ago. Oh yeah....anyone remember when pumpies were claiming a 60 minutes episode was about Celldex at Duke University? That was a classic!!!!!!!
Short interest down approximately 2.8 million shares. Can't remember the last time it was under 15 million. This should continue to wind down over the next several months heading into news this fall.
OK, I have been wishing on a star, but I need help here. So come on guys. I have added to my position at these cheap, I repeat cheap share prices and all it does is drive the price down. Can't believe I can set such a low limit order and the damn thing gets filled. Not right at all.
Low volume, no market, no support. Yeah I know it is summer, our usual time for market lows, but my other bios are doing OK, so it is CLDX with the issue.
Is there a pony in this pile or not???
SOS, SOS, SOS...
CLDX....not sure if this would be a good buy despite being low priced. Looked at ARNA too. Gonna look at CLDX pipeline. Presently now with AVEO. , Tivo (Renal Cell Ca treatment) has been Recommended for Approval in the EU, heading for $4. Binary event end Aug. GLTA
Zack Investment Research, Inc. upgrades CELLDEX THERAPEUTICS INC from HOLD to BUY.
July 17, 2017 -- The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab. “HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan,”
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
Metric Study - open label - taking way too long to get to full enrollment = not a good sign Adding to ReAct was a far better bet - AM is a clown with poor business sense