Glemba with rash: I was disappointed that we didn't hear any update (good or bad) regarding using rash as a pharmacodynamic marker for glemba in melanoma. In June Davis mentioned that discussions with regulators were ongoing regarding the possibility of taking all comers with metastatic melanoma initially but focusing continued treatment on those who experience rash. He characterized this approach as something that is possible moving forward. On the most recent conference call they mentioned they were going to conduct biopsies pretreatment to see if they can replicate the selection effect of waiting for rash via a test so that they can instead focus initial treatment just on those most likely to respond. This could be highly disappointing if they are forced to do another trial with this new test to see if it's as effective as waiting for rash to develop in the first 5 days. It seems like the off-target/on-target debate is honing in on gpnmb expression in the skin causing the rash so really the rash is an on-target effect. It is not evident with BV, so this would make sense as an immune response related to gpnmb expression. OR......They're confident one of the combo therapies will push the ORR to a level where preselection in metastatic melanoma via the evidence of rash or other is no longer required. Whether glemba/varli in refractory or glemba/CPI, if the ORR is in the 20's or higher that should negate the need for rash assuming reasonable AE profile. AND If there is glemba/varli synergy there really should be a trial started soon in uveal melanoma. Each drug has shown efficacy separately and in combination it would be very interesting.
Tick tock, tick tock, soon WS will return from summer vacays and celldex stock will catch fire over the next couple months... !? IMO, the evolution has been laid out, cryptically? Perhaps. I believe BMS has already committed to a tentative deal for exclusive partnering rights to Glemba and Varli but CLDX will hold rights to partner in house molecules together. They will eventually create a immune-oncology cocktail that will destroy a specific cancer indication like TNBC, or rGBM, etc. And that's when it will get really interesting!?!
The importance of Opdivo to BMS is illustrated in BMS' 2nd qtr. Opdivo contributed 25% of BMS' net revenue in the 2nd qtr. $768m US and $427 ex US. It should generate sales of $5b in '17. CLDX's relationship with BMS is very important and I hope Varli can make Opdivo more effective. This relationship may be more important than an approved and partnered Glemba.
In a recent study of a type of metastatic colorectal cancer Opdivo had an ORR of 28% (it's been approved for this indication).
Looks like Celldex has chosen "Galembri" as glemba's brand name. That name was registered as a trademark on June 6, 2017.
Other names that had been reserved as possibilities included "Glemva" and "Garlemba", but although those were filed in 2015 and granted extensions as recently as March, "Galembri" is the only one of the three to have an officially registered status. Celldex is confident enough to have registered a brand name. That's encouraging, but not sufficient in itself.
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It's a critical time to have experienced regulatory personnel at the company. I wonder what went wrong after only four months on the job. Maybe it's just an input error by her on her LinkedIn page; the work history doesn't make sense for her jobs with Celldex and Insmed. It would help if Celldex had an online company directory.
Development and implementation of global regulatory strategies; alignment of development plans with regulatory legislative… See more on LinkedIn.
The good news is: CLDX is consistently down only when the market is open.. not so much on the weekend... LMAO!!!!!
There is little correlation between the success of one company to another. But if it can provide any glimmer of hop, I will say that CLDX feels exactly like EXEL felt like after EXEL's expensive prostrate cancer trial failed. The intra-day low for EXEL was as low as around $1.20. It was under $3 for a while. This wasn't very long ago, just around three years ago or thereabouts. I held on and then they started having sucess. I felt that they had some good science but lousy management. Particulalry from a financial standpoint. But good science can trump bad financial management. I held on to all my EXEL and now EXEL is $27. I have been following the very same track with CLDX, and I am hoping for the same result. The table can turn very quickly with just one successfully approved drug to build on and CLDX still has a good looking pipeline.
One wonders what his job consisted of all those years. His recent departure would be consistent with Celldex opting to have a partner market and sell glemba.
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NCI sponsoring Varli/Nivo in refractory lymphoma They did a minor update yesterday on the clinical trials site. But it's still encouraging that NCI is funding a varli and nivo trial to begin this December in 106 patients with lymphoma. Two days ago the 2011 varlilumab mono therapy study in lymphoma had its study completion date moved back another 6 months to December of this year.
This has ten bagger+ written all over it. Normal stocks don't trade like Cldx does. Even other small cap clinical bios. IOs who are large holders of the stock have been in complete control for a number of years and their strategy has been to make everyone who has went long become a loser. I'll give it to them....it's worked but completely obvious price control in an extremely controlled fashion. They have likely created a cohort of people who now will continually keep shorting based on its history of performance. Don't be on the short side once the tide turns. Cldx still has plenty of potential assets primed for commercialization but as of now priced as a one trick pony about to go BK. Don't let the share price and performance fool you. The market can be irrational for longer than you can stay solvent. Buy and hold and that's it.
Interesting article from NYT today. Not a surprise but evidence that most if not all programs at Celldex will likely be partnered.
Short interest as of the end of July down well over 1 million shares.
I can fix the race problem somewhat with a different, but correct statement and hypothosis.1. There is no such thing as "RACISM", we are all members of the same "race" the human race, get it.2. If I don'l like you because of your skin color, then I am practicing "ethnicism" NOT racism. 3. Only if I hated all humans would I be a "racist".4. Maybe then, as all members of the same unfortunate "race" with can take it a little easier on the folks of different ethnicity. Blacks are black because they friggin came from Africa, and they developed, over time, darker more pigmented skin to deal with the intense sun. The folks in Scandinavia, what's up with that, they all look like Casper the goast.The human race is dumb and you just can't fix dumb.At least stop calling it #$%$ racism and get with the facts, CNN, FOX news, I mean everyone does it.As far as Celdex goes, I lost big on Rintega. I got my Investor University tuition paid. I sold at 5 something and damn glad I did, this stock just feels hopeless for some reason, no news, crummy management, all eggs being tossing now in one basket, running out of money, NOT GOOD> DDD better work out or this is over cause Vardi isn't cutting it and the company they bought is a piper dreamers dream come true, what's wrong with this management anyway?
Service to the board re: "mark", who claims to have had a short position for two years and claims to have made a killing shorting CLDX. Read some of his history on this board going back to five months ago. As you will read below, "mark's" history of posts shows him to be a liar, and he has no credibility. Ignore him completely henceforth because he's only here to taunt and desperately attempt to get attention in his lonely, miserable, unhappy, pathetic existence.
mark5 months ago $CLDX conversation Whats it gonna take to see double digits again and what kind of time frame are we looking at. Seems they have some trials and data due this year and things sometimes ramp up before data. Or will we ever see double digits again? Honest feedback please. Thanks ReplyReplies (8)1
mark5 months ago $CLDX conversation Revisiting CLDX after getting a very expensive education in 2015 with this stock. Seem price has continued to drop and recently just flatlined between $3-$4. What are the chances CLDX makes another run to double digits? Seems they just need a little hype and things can get going in either direction pretty quickly. What does CLDX have coming that could give it the "hype" and what price could we see? Thanks ReplyReplies (2)3
mark5 months ago $CLDX conversation Owned CLDX in '4 and '15 when price was soaring. Made a nice chunk but was to dumb to sell and ended up selling for a huge loss after the Rentega disaster. Revisiting the co and see it has a big week coming up. What are the odds this thing sees 20's and 30's again in the next 12 months? Or is under 1 a real possibility? Price looks like failure is priced in and no hope on the horizon. Seems to be just flat lining the last 12 months. Any honest thoughts or input appreciated. Thanks ReplyReplies (2)42
New here and looking for feed back. Seems a lot of the posters think that this Co has got the next big thing to cure major cancers. But yet the volume is horrible and the price drops everyday. Shouldn't it be the opposite? It also seems that mgmt. talks a big talk to steal peoples money and has never produced 1single product.....is that a true statement? Any help from someone other than a pumper would be great. And why does mgmt. get big bonuses for doing nothing?
How funny would it be if the Glemba trial got stopped for efficacy. I bet we wouldn't hear from mark anymore
WELL SAID WHIP! MARKS MUTED!
I suggested NTEC here and got the razzo up the wazzoo. check it out now. Aside from the Levadopa Parkinson's phase three Acordian study, they kicked GW Phama SativexTHC nose spray in a phase one 21 patient Accordian pill study. This is major, This is a significant drug dellvery technology rather than a wait forever and continue failing drug candidate study. I gave it to you at 5.20, it is up to 6.15 +.45 today and up 1.50 the last three days. Volume has picked up big time as well.
2Q'17 cc: notes
1. Glemba: - METRIC over-enrollment beyond 300 patient target is potentially a good sign. The trial is unmasked to the physicians, and if they want to continue enrollment it's not because of the 2 months PFS provided by control arm Xeloda. - staged approach to manufacturing process and possible partnering: I think this will be contingent on the outcome of the various glemba trials: if all indications pan out (breast cancer, osteosarcoma, metastatic melanoma and uveal melanoma) they will definitely partner because they don't have the resources to cover all patient populations. If only a couple of indications pan out they may go it alone (although after a couple of years of well compensated inertia, 3 hour- 3 martini lunches and golf Wednesdays, having to do a little work may be a severe shock to the health of the commercial/marketing staff and may turn out to be contraindicated activity for them -)...)
2. Varli: - Varli+Glemba PII combo enrollment in metastatic melanoma complete, results in fall'17. - Varli + Opdivo PII combo enrollment in several solid tumor indications will complete in 1Q'18, I would expect results to be announced ASCO'18.
3. Kolltan drugs: - progressing in trials, but no clarity on efficacy (until convinced otherwise, I continue to think that these are marginally effective drugs, perhaps combo with Varli will boost efficacy, but still TBD).
4. Concerns: - cash position, pps: I don't think they could've selected a worse possible time for the sale of stock from the Cantor agreement. If I were to wax cynical, I'd say it was to hammer down pps for maximum return on strike price for their option grants... - it feels more and more like BMS will pull a Medarex 2.0 and buy CLDX if they like what they see from the Varli trials (with glemba as frosting on the cake...). Not a bad way for BMS to leverage a small $5 million investment...
Rays of hope shining through, but CLDX is still in the sub-$5 penny stock category, and CLDX management has to execute flawlessly from this point forward to transform this co into a successful commercial stage biotech.
SLIPPIN.....AGAIN. but hey, they got a big bad trademark name for their new phony drug from trademarkia.com. Thats almost comical the scams these morons are trying to pull. #moreshortprofit