Trader Take on Dendreon Ahead (DNDN, LLY)
Dendreon Corp. (NASDAQ: DNDN) is so far having very little movement from its presentation at the JPMorgan healthcare conference in San Francisco. We saw a CNBC interview earlier this week that gave us hope for some more additional data on its PROVENGE trial for prostate cancer.
The company said today that it now expects to report additional data over the PROVENGE trial by April. We have our own thoughts on how traders and investors can use that date to their advantage.
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Breaking Down Dendreon's Move (DNDN)
Dendreon Corp. (NASDAQ: DNDN) is one biotech stock where traders and investors alike also join groups of patients in their march toward to the company. The stock was an incredible performer today, and one which makes you wonder how well it would have done had the stock market not been so ugly.
Dendreon traded up 33% today to $6.93 on more than 35 million shares. At one point its stock traded north of $9.00. It traded more than 40,000 Call Option contracts today for the October current month expirations, it traded over 37,000 call option contracts for November expiration, and traded over 90,000 call option contracts for the January-2009 expiration. If you add all that up on a fully leveraged basis, you would see that this is equivalent to more than another 16.7 million shares.
- Over at 24/7 Wall St. we gave our expectations ahead for the stock, and below is all the data from the company.
Its interim data from Phase III PROVENGE IMPACT trial showed that the IDMC observed no safety concerns, and it recommended that the study continue. The company itself has completed the planned interim analysis of the Phase III, randomized, double-blind, placebo-controlled IMPACT clinical trial designed to assess the safety and efficacy of PROVENGE in men with metastatic androgen-independent prostate cancer. We do want to outline how that despite this data being good, Dendreon is not suddenly a slam dunk and still has many risks associated with it.
Dendreon remains blinded to the data, but the independent data monitoring committee reported to Dendreon a 20% reduction in the risk of death in the PROVENGE arm relative to placebo and observed no safety concerns and recommended that the study continue to its final analysis.
The final analysis is expected in the middle of 2009 and if the study demonstrates approximately a 22% reduction in the risk of death (based on 304 events), the company would expect the study to meet its primary endpoint of overall survival.
Jon C. Ogg
October 6, 2008
Something Brewing At Dendreon? (DNDN)
We just noticed a large options volume alert over at Volume Spike today, and it is one that biotech investors may care about quite a bit more because of the timing. We have witnessed a flurry of trading in Dendreon Corp. (NASDAQ: DNDN) November stock options activity today.
We have seen what would represent more than 2 million shares in a risk reversal trade, although it could be called a myriad of terms depending upon your sophistication in trading. Frankly, most would call it a synthetic straddle.
As far as our calendar is concerned, we didn’t have any major event risk scheduled on the calendar until 2009.
After looking around there is actually some data coming out as soon as October, but the biggest data is still out into next year. This is probably simple to explain. Either someone put on a massive belief trade or they are hedging a large position of stock.
Jon C. Ogg
July 31, 2008
Cell Genesys Positive Prostate Cancer Study Data (CEGE, DNDN)
Cell Genesys, Inc. (NASDAQ: CEGE) has announced that the final data from the second of two Phase II clinical trials (G-0010) of GVAX immunotherapy for prostate cancer has been published in the online issue of Cancer. This is the publication of the American Cancer Society.
As a reminder, this company is somewhat after the same goal as Dendreon (NASDAQ: DNDN) in the fight to treat prostate cancer.
The results from this Cell Genesys multi-center trial showed an overall median survival of 35.0 months in the subset of patients who received a dose of GVAX immunotherapy for prostate cancer comparable to that currently being evaluated in the ongoing Phase 3 program. It also noted that these results were consistent with those observed in the first multi-center Phase II trial which indicated an overall median survival of 34.9 months in those patients who received a dose comparable to that being evaluated in the Phase III program.
The survival results from both Phase II clinical trials compare favorably to the previously published median survival for metastatic hormone-refractory prostate cancer patients treated with Taxotere® chemotherapy plus prednisone, the current standard of care for this patient population.
A copy of this article titled “Phase 1/2 Dose-Escalation Study of a GM-CSF-Secreting, Allogeneic Cellular Immunotherapy for Metastatic Hormone-Refractory Prostate Cancer” can be seen at the following URL:
http://www3.interscience.wiley.com/journal/120840830/abstract
As a result, the company notes that it is on track to complete enrollment of the second of the two ongoing Phase III trials, in the first half of 2009 and its expects to reach the number of events needed to trigger final analysis of the first of the two Phase III trials in the second half of 2009.
Much of this data seems to be reaffirming what has already been observed. But this stock has a huge short interest of more than 18.4 million shares and this has shares indicated about 5% higher in the immediate pre-market reaction.
Jon Ogg
July 22, 2008
Regeneron Feels Cancer Setback (REGN)
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has provided an update on its clinical development program for aflibercept, which includes results from a Phase 2 study in advanced ovarian cancer. The drug is under development with Sanofi-Aventis (NYSE: SNY).
Unfortunately, this study failed to meet its primary endpoint of achieving a base of 5% response based on certain criteria in two dosage strengths. These results were from an independent review committee. The higher dosage of aflibercept achieved a 4.5% response, but the lower dose generated a mere 0.9% response.
The companies are still evaluating their next steps to take in the advanced ovarian cancer indication, although this response rate is low enough that you have to wonder if the entire program for this indication will be shelved so it can concentrate on the other indications.
The companies are still evaluating aflibercept as a chemotherapy combination potential treatment in four late-stage studies to evaluate the treatment of prostate, pancreatic, colorectal, and non-small cell lung cancers.
Regeneron still has more than ample cash and liquidity to keep funding its existing trials and existing programs. With $826 million total liquidity as of last quarter (cash, equivalents, long-term investments) and total liabilities of $470 million, the company even has enough dough to look for new opportunities.
Shares of Regeneron are down 14% at $18.40 and the 52-week trading range is $13.55 to $25.25. If this was the only program and if there was less liquidity, the drop would have been far worse.
Jon Ogg
May 21, 2008
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