Vaccines are becoming popular again – As PD-1 antibodies modulate the suppressive tumor microenvironment, they are viewed by many as enablers of cancer vaccines. PD-1 antibodies are expected to rime the immune system in general while vaccines will guide the immune system to the right antigens.
July 29, 2014
PFE Pfizer says will look at all deals 'regardless of size' Comment made on the Q2 earnings conference call.
$CLDX is designed phase 3 trial with $PFE last I heard, results from 110 very good despite no action after ASCO.
CLDX Phase III trial is based on encouraging results from prior clinical trials, Phase III trials for Glioblastoma multiforma brain cancer treatment. CLDX has significant commitment in that area.
CLDX) rallied 6.74% on Wednesday after Puma Biotechnology released positive data for its breast cancer drug and an analyst at Citigroup said that the company would probably become a takeover target. Citigroup analyst Yaron Werber wrote that he expects PUMA to be acquired after the data. The data represents a best-case scenario, and there is an 85% chance that the drug will be approved, the analyst stated. Neratinib should generate peak sales of at least $4.1B, according to Werber. He hiked his price target on the stock to $292 from $99.
SELL !!!!!!! The stock has a beta of 3.18 and a short float of 20.9% with 8.32 days to cover. Shares are down 41.5% year-to-date as of the close of trading on Wednesday.............nobody is STUPID .
SHORT SQUEEZE ON THE WAY...
The company reported today that it has received the go ahead from the FDA to file an NDA for Eteplirsen by the end of 2014. .... Yes biotech stocks are risky but they eventually rise as they pass clinical trials. ..... The drug used for the METRIC study is known as CDX-011.
Even after a year - This p2 results are still valid just waiting for the interim results.
Celldex has already proven that its drug works. CDX-011 has already extended life, slowed progression, and had a high response rate in 120 patients. To me, it is clear which product has the highest upside in the breast cancer market. When you consider CDX-011’s sales potential of $700 million and the fact that Celldex has a large pipeline with one other late-stage brain cancer drug, I think it’s clear that Celldex makes a great investment.
CDX-011 is a vaccine used to treat patients with advanced/metastatic breast cancer who express the protein GPNMB. The FDA has granted Fast Track designation to CDX-011 for the treatment of advanced, refractory/resistant GPNMB-expressing breast cancer.
What’s impressive about CDX-011 is that it was proven effective on patients who had no longer responded to a median of five-six prior therapies; meaning most difficult to treat. Yet, of the 120 patients treated with CDX-011, 33% had a response rate compared to no response in patients using chemotherapy. Moreover, CDX-011 slowed the growth of tumors by 100% compared to its control arm.
Due to the stage of the disease, such progress is considered incredible. The technology used is equally impressive, as the success from the trial proves that targeting GPNMB is highly effective in treating such violent diseases. Thus, investors are excited that this protein is also expressed in multiple tumors such as melanoma and glioma.
Moving forward, the question is not whether the drug will be approved, but rather when it will be approved. The FDA is already showing favoritism towards the drug, and has a history of rapidly approving drugs for life-threatening cancers. As a result, there’s a lot to like when it comes to Celldex.
CLDX will give out interim results by 6th August as they said during QTRLY report wrap up 2014.
Leaked: This coming blockbuster will make every biotech jealous
The best biotech investors consistently reap gigantic profits by recognizing true potential earlier and more accurately than anyone else. Let me cut right to the chase. There is a product in development that will revolutionize not just how we treat a common chronic illness, but potentially the entire health industry. Analysts are already licking their chops at the sales potential.
Rindopepimut - Brain Cancer
Celldex's most advanced clinical candidate, rindopepimut, is indicated as a potential treatment for glioblastoma multiforme, a particularly aggressive and difficult-to-treat form of brain cancer. What's key to understand is that numerous experimental treatments for glioblastoma have failed in clinical trials over the years. Roche's Avastin was the first pharmaceutical approved by the Food and Drug Administration to treat any form of glioblastoma in over a decade, and even it can only claim marginal clinical benefits for this terrible disease.
Glembatumumab- Breast Cancer
The company's second most advanced clinical candidate, Glembatumumab vedotin, is based on Seattle Genetics' (NASDAQ: SGEN ) promising antibody-drug conjugate, or ADC, technology that consists of a human monoclonal antibody linked to a potent cellular toxin. Glembatumumab is being tested as a potential treatment for breast cancer and melanoma.
Puma Biotechnology Inc. (PBYI) almost tripled in extended trading after the company said a clinical trial of its experimental drug blocked the return of breast cancer in women with a type of early-stage disease.
The drug, neratinib, improved disease-free survival by 33 percent compared with a placebo in a trial of 2,821 women with early-stage HER2-positive breast cancer, Los Angeles-based Puma said today in a statement. Disease-free survival refers to the interval a patient remains alive and free of signs of the illness. The company said it would apply for U.S. regulatory approval in the first half of 2015 based on the results.
Puma almost tripled to $169.48 in extended trading at 5:35 p.m. New York time after closing at $59.03. The company had declined 43 percent this year.
If PANDORA of CDX1135 OPENED again I m sure this will attract many more indications then Alexion Solaris. I really don't understand that why they are not pursuing other indications where possibilities are many?
With Soliris being the priciest drug in the U.S., having multiple uses, and being expected to generate sales over $2 billion this year, investors were excited about CDX-1135's developmental possibilities. Theoretically, if CDX-1135 was successful, many believed it could one day challenge Alexion in treating many of the same diseases. This would consequently potentially effect Soliris' pricing and Alexion's $30 billion market capitalization. It was a big blow for Celldex to close the program, but it was possibly a big win for Alexion.