Dan Rosenblum - Seeking Alpha 'Dan Rosenblum' Tag RSS Syndication from SeekingAlpha.com SeekingAlpha.com http://seekingalpha.com/author/dan-rosenblum Expect Targacept to Move Higher http://seekingalpha.com/article/167907-expect-targacept-to-move-higher?source=feed 167907 Having seen small biotech stocks (Dov Pharma and Interneuron to name two) that showed promising Phase 2 results in treatments for depression which ended up failing after the drugs advanced into Phase 3, I was somewhat skeptical of Targacept's (TRGT) rapid rise from $4 to $20 over the summer caused by the company's announcement that its Phase 2b results of TC-4214 showed highly significant results when combined with Celexa in treating depression.

My thought was that a two point or even a three point improvement in either the HAMD or MADRS depression rating scale over placebo might not look so impressive when the drug goes into much larger Phase 3 studies and the results tend to be more modest .

]]> Wed, 21 Oct 2009 14:24:21 -0400 Dan Rosenblum Dan Rosenblum submits:

Having seen small biotech stocks (Dov Pharma and Interneuron to name two) that showed promising Phase 2 results in treatments for depression which ended up failing after the drugs advanced into Phase 3, I was somewhat skeptical of Targacept's (TRGT) rapid rise from $4 to $20 over the summer caused by the company's announcement that its Phase 2b results of TC-4214 showed highly significant results when combined with Celexa in treating depression.

My thought was that a two point or even a three point improvement in either the HAMD or MADRS depression rating scale over placebo might not look so impressive when the drug goes into much larger Phase 3 studies and the results tend to be more modest .


Complete Story »]]> TRGT Dan Rosenblum Why Sales Estimates for Dendreon's Provenge Are Too Low http://seekingalpha.com/article/138294-why-sales-estimates-for-dendreon-s-provenge-are-too-low?source=feed 138294 After the initial excitement caused by the Phase 3 IMPACT study of Dendreon's (DNDN) Provenge for the treatment of metastatic prostate cancer has begun to fade (along with the stock price), it is time to consider just how big a drug Provenge can become.

Provenge is still around a year away from getting FDA approval, so I am sure many investors feel there is no rush to get involved in the stock at this point. The company's manufacturing facility will also go through a rigorous once over from the agency, and the data from the trials will be scrutinized with a fine tooth comb but make no mistake, Provenge will be approved and will become a blockbuster drug.

]]> Mon, 18 May 2009 15:40:22 -0400 Dan Rosenblum Dan Rosenblum submits:

After the initial excitement caused by the Phase 3 IMPACT study of Dendreon's (DNDN) Provenge for the treatment of metastatic prostate cancer has begun to fade (along with the stock price), it is time to consider just how big a drug Provenge can become.

Provenge is still around a year away from getting FDA approval, so I am sure many investors feel there is no rush to get involved in the stock at this point. The company's manufacturing facility will also go through a rigorous once over from the agency, and the data from the trials will be scrutinized with a fine tooth comb but make no mistake, Provenge will be approved and will become a blockbuster drug.


Complete Story »]]> DNDN Dan Rosenblum ASCO: Whose Presentations Look the Most Promising? http://seekingalpha.com/article/78913-asco-whose-presentations-look-the-most-promising?source=feed 78913 With this year's annual American Society of Clinical Oncology [ASCO] meeting coming up this weekend I thought I might give a heads up on a few companies whose presentations might look interesting to investors.
 
Unlike most years where the conference abstracts were unavailable to the public prior to the conference, this year the ASCO chiefs decided to make them public two weeks before the meeting. While quite often an abstract cannot be a substitute for seeing an entire presentation it can give you a heads up to where the most exciting (or disappointing) presentations will come from.
 
By far the most important data to be released will be from Imclone (IMCL) where the so-called FLEX study on Erbitux in non small cell lung cancer [NSCLC] will be presented at the plenary session (there was no abstract available for this study of course). Since it's been nine months since Imclone announced that this trial was positive there has been lots of speculation on exactly how good this data really is. It seems that the consensus by now, based on comments by Imclone's European partner Merck-AG (MRK), is that Erbitux showed no progression free survival [PFS] benefit and the overall survival benefit is likely to be about four or five weeks. It's due to the low expectations that Imclone is trading only slightly higher than where the stock was trading before Imclone announced that the FLEX study was positive.
 
So for the presentation on FLEX to have a big positive impact for the stock I think the overall survival rate would probably have to be at least five weeks. Another thing to look for is the overall side effect profile. If it's relatively benign that could boost the stock as well. 
 
One thing to note though is that this FLEX study was unique in some ways in that it included all NSCLC patients not just those likely to benefit from Erbitux, unlike Genentech's Avastin which was only studied in non-squamous cell patients and excluded very sick patients. This is more of a real world look at the drug's benefit than most other trials and any real survival benefit should lead to both approval by the FDA and wide use by oncologists.
 
Also of importance to Imclone will be results from a study of Erbitux (and other drugs in the same class of EGFR inhibitor drugs like Amgen's (AMGN) Vectibix and OSI's (OSIP) Tarceva) in patients who have the KRAS mutation gene. It is generally assumed that patients who have this gene respond better to EGFR inhibitors than other patients, but analysts are divided as to whether the knowledge will lead to more use of EGFR inhibitors. Physicians will either be more likely to use them in those patients even possibly as a first line therapy, or less likely since physicians will be more reticent to use them in patients without the KRAS gene.
 
Moving onto other stocks of note, I for one am really excited about Incyte Pharmaceutical's (INCY) INCB18424, for the treatment of myelofibrosis, which is a disease which effects the bone marrow and causes enlargement of the spleen. The abstract showed there was a rapid and significant reduction in splenomegaly, with reductions from baseline of 53% at one month and 76% at three months. This could become the first drug ever approved for myelofibrosis and should rapidly advance through clinical trials.
 
Celgene (CELG) had some interesting data on a combination trial with the two leading drugs Velcade and Revilimid in multiple myeloma. The combination was better than using either as a single agent, and this could lead to the added use of both drugs.
 
Ariad Pharmaceutcals (ARIA) had some data which showed its oral version of the bone cancer drug deforolimus was better than its IV version, with a 25% response rate. The problem for ARIA though is that there is very tough competition in bone cancer from  Amgens's denosumab, which has some outstanding Phase 2 data with an unheard of 85% response rate.
 
Regeneron (REGN) had some interesting early data of the company's VEGF Trap in brain tumors. The response rate in one type of tumor (glioma) was 50% and in the other (glioblastoma) was 30%. In comparison the early data for Avastin was about a 20% response rate.
 
Seattle Genetics (SGEN) should have impressive data on SGN-35 for the treatment of refractory Hodgkin's lymphoma. The abstract showed that 54% of patients at the higher dose levels had a partial response.
 
One tiny stock to look for is YM Biosciences [YMI], which has interesting early data on nimotuzumab in lung cancer and head and neck cancer. There is also an abstract for a phase 3 trial of  the drug in glioma without any data. One thing to note on YMI though is that pivotal phase 3 data for nimotuzumab is due in the near term and that will likely be a make or break event for the company.
 
Finally, Immunogen (IMGN) should have updated data on it's TDM-1 linked with Herceptin at ASCO. Some investors seem to think that the drug has potential to become the standard of care for Herceptin refractory patients. The key for Immunogen will be if Genentech (DNA) decides to take the drug into phase 3 trials. A decision will likely be made later this year.
 
Long IMCL, INCY, CELG, IMGN.
]]> Tue, 27 May 2008 05:30:29 -0400 Dan Rosenblum Dan Rosenblum submits:
With this year's annual American Society of Clinical Oncology [ASCO] meeting coming up this weekend I thought I might give a heads up on a few companies whose presentations might look interesting to investors.
 
Unlike most years where the conference abstracts were unavailable to the public prior to the conference, this year the ASCO chiefs decided to make them public two weeks before the meeting. While quite often an abstract cannot be a substitute for seeing an entire presentation it can give you a heads up to where the most exciting (or disappointing) presentations will come from.
 
By far the most important data to be released will be from Imclone (IMCL) where the so-called FLEX study on Erbitux in non small cell lung cancer [NSCLC] will be presented at the plenary session (there was no abstract available for this study of course). Since it's been nine months since Imclone announced that this trial was positive there has been lots of speculation on exactly how good this data really is. It seems that the consensus by now, based on comments by Imclone's European partner Merck-AG (MRK), is that Erbitux showed no progression free survival [PFS] benefit and the overall survival benefit is likely to be about four or five weeks. It's due to the low expectations that Imclone is trading only slightly higher than where the stock was trading before Imclone announced that the FLEX study was positive.
 
So for the presentation on FLEX to have a big positive impact for the stock I think the overall survival rate would probably have to be at least five weeks. Another thing to look for is the overall side effect profile. If it's relatively benign that could boost the stock as well. 
 
One thing to note though is that this FLEX study was unique in some ways in that it included all NSCLC patients not just those likely to benefit from Erbitux, unlike Genentech's Avastin which was only studied in non-squamous cell patients and excluded very sick patients. This is more of a real world look at the drug's benefit than most other trials and any real survival benefit should lead to both approval by the FDA and wide use by oncologists.
 
Also of importance to Imclone will be results from a study of Erbitux (and other drugs in the same class of EGFR inhibitor drugs like Amgen's (AMGN) Vectibix and OSI's (OSIP) Tarceva) in patients who have the KRAS mutation gene. It is generally assumed that patients who have this gene respond better to EGFR inhibitors than other patients, but analysts are divided as to whether the knowledge will lead to more use of EGFR inhibitors. Physicians will either be more likely to use them in those patients even possibly as a first line therapy, or less likely since physicians will be more reticent to use them in patients without the KRAS gene.
 
Moving onto other stocks of note, I for one am really excited about Incyte Pharmaceutical's (INCY) INCB18424, for the treatment of myelofibrosis, which is a disease which effects the bone marrow and causes enlargement of the spleen. The abstract showed there was a rapid and significant reduction in splenomegaly, with reductions from baseline of 53% at one month and 76% at three months. This could become the first drug ever approved for myelofibrosis and should rapidly advance through clinical trials.
 
Celgene (CELG) had some interesting data on a combination trial with the two leading drugs Velcade and Revilimid in multiple myeloma. The combination was better than using either as a single agent, and this could lead to the added use of both drugs.
 
Ariad Pharmaceutcals (ARIA) had some data which showed its oral version of the bone cancer drug deforolimus was better than its IV version, with a 25% response rate. The problem for ARIA though is that there is very tough competition in bone cancer from  Amgens's denosumab, which has some outstanding Phase 2 data with an unheard of 85% response rate.
 
Regeneron (REGN) had some interesting early data of the company's VEGF Trap in brain tumors. The response rate in one type of tumor (glioma) was 50% and in the other (glioblastoma) was 30%. In comparison the early data for Avastin was about a 20% response rate.
 
Seattle Genetics (SGEN) should have impressive data on SGN-35 for the treatment of refractory Hodgkin's lymphoma. The abstract showed that 54% of patients at the higher dose levels had a partial response.
 
One tiny stock to look for is YM Biosciences [YMI], which has interesting early data on nimotuzumab in lung cancer and head and neck cancer. There is also an abstract for a phase 3 trial of  the drug in glioma without any data. One thing to note on YMI though is that pivotal phase 3 data for nimotuzumab is due in the near term and that will likely be a make or break event for the company.
 
Finally, Immunogen (IMGN) should have updated data on it's TDM-1 linked with Herceptin at ASCO. Some investors seem to think that the drug has potential to become the standard of care for Herceptin refractory patients. The key for Immunogen will be if Genentech (DNA) decides to take the drug into phase 3 trials. A decision will likely be made later this year.
 
Long IMCL, INCY, CELG, IMGN.

Complete Story »]]> ARIA CELG IMCL IMGN INCY OSIP REGN SGEN Dan Rosenblum AMAG Pharma: What's Taking the FDA So Long? http://seekingalpha.com/article/72652-amag-pharma-what-s-taking-the-fda-so-long?source=feed 72652 Last week, our old analyst friend at Merrill Lynch, Andrew Berens, downgraded AMAG Pharmaceuticals (AMAG) for the third time in ten weeks, this time to sell.

Mr. Berens rehashed his previous worries, namely that based on discussions with FDA officials, AMAG might not have enough safety data to get approval for ferumoxytol on the first go around this fall. He is also concerned that the ferumoxytol trials were of a lower total dosage than a patient would be receiving in the real world over a year's time. He expects the FDA to request a large safety study which will push approval to the back half of 2011.

]]> Thu, 17 Apr 2008 06:41:53 -0400 Dan Rosenblum Dan Rosenblum submits:

Last week, our old analyst friend at Merrill Lynch, Andrew Berens, downgraded AMAG Pharmaceuticals (AMAG) for the third time in ten weeks, this time to sell.

Mr. Berens rehashed his previous worries, namely that based on discussions with FDA officials, AMAG might not have enough safety data to get approval for ferumoxytol on the first go around this fall. He is also concerned that the ferumoxytol trials were of a lower total dosage than a patient would be receiving in the real world over a year's time. He expects the FDA to request a large safety study which will push approval to the back half of 2011.


Complete Story »]]> AMAG Dan Rosenblum Insider Buying in Biotech Land http://seekingalpha.com/article/70650-insider-buying-in-biotech-land?source=feed 70650 Insider buying in the biotech sector is something I rarely ever look at, mostly because it is usually pretty rare that biotech insiders are buyers and not sellers. Biotech insiders know better than anyone that the drug discovery and approval process is one fraught with danger and that they should sell when the opportunity arises.

However, with the market and the biotech sector taking a massive beating, I was wondering if insiders were taking the opportunity to buy some of their own stock at much cheaper levels than they were trading at just a few months ago. Here are a few things that jumped out at me.

]]> Tue, 01 Apr 2008 03:03:35 -0400 Dan Rosenblum Dan Rosenblum submits:

Insider buying in the biotech sector is something I rarely ever look at, mostly because it is usually pretty rare that biotech insiders are buyers and not sellers. Biotech insiders know better than anyone that the drug discovery and approval process is one fraught with danger and that they should sell when the opportunity arises.

However, with the market and the biotech sector taking a massive beating, I was wondering if insiders were taking the opportunity to buy some of their own stock at much cheaper levels than they were trading at just a few months ago. Here are a few things that jumped out at me.


Complete Story »]]> HGSI MRBK OMRI PGNX RIGL VRTX VRUS XNPT Dan Rosenblum Nanosphere Will be a Big Winner http://seekingalpha.com/article/69329-nanosphere-will-be-a-big-winner?source=feed 69329 It was quite interesting listening to both the Cepheid (CPHD) and the Nanosphere (NSPH) quarterly conference calls recently. It occurred to me that NSPH is possibly exactly where CPHD was two years ago. Then, CPHD was a promising little company with a new molecular diagnostic machine that was trying to break into the market. Now, with the establishment of their test to diagnose the MRSA virus, their machine is a hot item and is growing close to 50% annual rate which has led to CPHD's current market cap of $1.5 billion

]]> Thu, 20 Mar 2008 04:45:46 -0400 Dan Rosenblum Dan Rosenblum submits:

It was quite interesting listening to both the Cepheid (CPHD) and the Nanosphere (NSPH) quarterly conference calls recently. It occurred to me that NSPH is possibly exactly where CPHD was two years ago. Then, CPHD was a promising little company with a new molecular diagnostic machine that was trying to break into the market. Now, with the establishment of their test to diagnose the MRSA virus, their machine is a hot item and is growing close to 50% annual rate which has led to CPHD's current market cap of $1.5 billion


Complete Story »]]> NSPH Dan Rosenblum