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Showing posts with label biotech. Show all posts
Showing posts with label biotech. Show all posts
Friday, December 28, 2012
Investopedia: A Look Back At The Year In Biotech
Despite 2012 being a year where investors were increasingly skittish as
the year wore on, the exceptionally risky biotechnology industry enjoyed
an exceptionally good year. While the group has come off a bit from its
peak in the early fall, the group is up more than 30% year to date -
making it not only a strong outperformer relative to the S&P 500 (which is up about 12%), but one of the best-performing groups of the year.
Continue reading here:
http://www.investopedia.com/
Continue reading here:
http://www.investopedia.com/
Friday, December 16, 2011
Investopedia: The Top Biotech Performers of 2011
This has really been a year of the "haves" versus the "have nots" in biotechnology. Although a few dedicated biotech ETFs have done rather well and there have been some huge individual outperforming stocks, the sector as a whole has not necessarily been all that strong. Still, for those companies that could deliver encouraging data, particularly in the fields of hepatitis and cancer, the market was more than willing to reward the stocks with a higher valuation.
Hepatitis C - The Story of 2011
If any one theme should leap out at biotech investors in 2011, it is the explosion of interest in companies targeting hepatitis C. It is not as though hepatitis C is a new disease, but a host of companies have finally developed compounds that look to offer major improvements in disease management and quality of life for the millions of people with this condition.
Two of the top three performing biotechs with current market capitalizations above $250 million are hepatitis C plays. Pharmasset (Nasdaq:VRUS) has delivered the sort of year that biotech investors dream about for 2011, with the stock up nearly 500% in the last year. The stock was already doing incredibly well on the basis of very strong clinical data in PSI-7977 trials - data that basically showed 100% response in early administration of the drug. This stock found another level, though, when Gilead Sciences (Nasdaq:GILD) stepped up and offered to pay a considerable premium to acquire the company.
To read the full article, click here:
http://stocks.investopedia.
Hepatitis C - The Story of 2011
If any one theme should leap out at biotech investors in 2011, it is the explosion of interest in companies targeting hepatitis C. It is not as though hepatitis C is a new disease, but a host of companies have finally developed compounds that look to offer major improvements in disease management and quality of life for the millions of people with this condition.
Two of the top three performing biotechs with current market capitalizations above $250 million are hepatitis C plays. Pharmasset (Nasdaq:VRUS) has delivered the sort of year that biotech investors dream about for 2011, with the stock up nearly 500% in the last year. The stock was already doing incredibly well on the basis of very strong clinical data in PSI-7977 trials - data that basically showed 100% response in early administration of the drug. This stock found another level, though, when Gilead Sciences (Nasdaq:GILD) stepped up and offered to pay a considerable premium to acquire the company.
To read the full article, click here:
http://stocks.investopedia.
Wednesday, March 9, 2011
Investopedia: A Primer On The Biotech Sector
Biotechnology is one the strangest, scariest, sexiest and most interesting corners of the stock market. In how many other industries are companies striving to literally save lives? Any industry can host a stock that could potentially double, but what other industry can match biotechnology in the sheer number of stocks that could double if their companies' plans all come to fruition?
On the other hand, in how many other industries do companies burn through hundreds of millions of dollars, often with nothing to show for it? How many other industries rely on scientific arcana that can be challenging to even highly qualified Ph.D.s? And how many other industries sport a warning label that reads “Caution: Poor stock selection may cost you 90% of your initial investment”?
For all those reasons and more, biotechnology is a fascinating industry for investors to explore. (For a background reading, see The Ups And Downs Of Biotechnology.)
What Is Biotechnology?
In a nutshell, biotechnology is an industry that focuses on novel drug development and clinical research aimed at treating diseases and medical conditions. Biotechnology companies are almost always unprofitable (some suggest that the distinction between “biotech” and “pharmaceutical company” lies in profitability), and many have no real revenue at all.
To read the full piece, please go to:
http://www.investopedia.com/
For all those reasons and more, biotechnology is a fascinating industry for investors to explore. (For a background reading, see The Ups And Downs Of Biotechnology.)
What Is Biotechnology?
In a nutshell, biotechnology is an industry that focuses on novel drug development and clinical research aimed at treating diseases and medical conditions. Biotechnology companies are almost always unprofitable (some suggest that the distinction between “biotech” and “pharmaceutical company” lies in profitability), and many have no real revenue at all.
To read the full piece, please go to:
http://www.investopedia.com/
Tuesday, October 19, 2010
I Think I Give Up On The FDA
With tonight's news of Amylin (Nasdaq: AMLN) getting yet another complete response letter (CRL) from the FDA on Bydureon, I am just about ready to give up on the FDA. Even though Bydureon has shown no particular cardiovascular risk, the FDA has decided to ask for a QT study - a request that is going to take at least a year to fulfill (to say nothing of another six months or so for review).
I would love to know why the FDA did not request this back in the first CRL. I cannot stand conspiracy theorizing, but I am beginning to wonder if the FDA has just decided to abandon its supposed mission of evaluating the safety and efficacy of new drugs in favor of just ruling that any and all new drugs are potentially unsafe and therefore unapprovable.
Although I think Amylin has the capital to endure this delay, and I still believe Bydureon is the best drug in its class, I do not know how anybody can just assume that the drug will get approval. It seems clear to me that the FDA does NOT want to approve this drug and will come up with whatever obstacles are necessary to block it.
By the same token, then, this is bad news for any company looking to get a new compound through the FDA. Maybe Big Pharma can still push some compounds through, but it feels like the little companies do not stand a chance.Good luck, then, to Biodel (Nasdaq: BIOD) and its problematic Phase 3 data on Linjeta - if the FDA will not approve Bydureon, I cannot see how Biodel gets through.
I wonder how long this will go on before somebody decides it is time to audit and investigate the FDA and re-examine its mandate. I appreciate and respect the necessity of protecting the public from unsafe drugs, but allowing unmet medical needs to remain unmet simply because of fanciful fears of possible harm does nobody any good. At this point, I argue that the FDA is abusing its mandate and needs a Congressional slap upside the head to remind it of its obligations to facilitate the introduction of new drugs and devices.
Anyways, I do not wish to turn this into a long-winded rant about the FDA, so I will bring this to a close. This is a major disappointment to Amylin shareholders, but it is not the end of the story yet. I still have some hope that this story will work out, but it is definitely going to take longer than I had hoped.
Disclosure - I own shares of Amylin
I would love to know why the FDA did not request this back in the first CRL. I cannot stand conspiracy theorizing, but I am beginning to wonder if the FDA has just decided to abandon its supposed mission of evaluating the safety and efficacy of new drugs in favor of just ruling that any and all new drugs are potentially unsafe and therefore unapprovable.
Although I think Amylin has the capital to endure this delay, and I still believe Bydureon is the best drug in its class, I do not know how anybody can just assume that the drug will get approval. It seems clear to me that the FDA does NOT want to approve this drug and will come up with whatever obstacles are necessary to block it.
By the same token, then, this is bad news for any company looking to get a new compound through the FDA. Maybe Big Pharma can still push some compounds through, but it feels like the little companies do not stand a chance.Good luck, then, to Biodel (Nasdaq: BIOD) and its problematic Phase 3 data on Linjeta - if the FDA will not approve Bydureon, I cannot see how Biodel gets through.
I wonder how long this will go on before somebody decides it is time to audit and investigate the FDA and re-examine its mandate. I appreciate and respect the necessity of protecting the public from unsafe drugs, but allowing unmet medical needs to remain unmet simply because of fanciful fears of possible harm does nobody any good. At this point, I argue that the FDA is abusing its mandate and needs a Congressional slap upside the head to remind it of its obligations to facilitate the introduction of new drugs and devices.
Anyways, I do not wish to turn this into a long-winded rant about the FDA, so I will bring this to a close. This is a major disappointment to Amylin shareholders, but it is not the end of the story yet. I still have some hope that this story will work out, but it is definitely going to take longer than I had hoped.
Disclosure - I own shares of Amylin
Friday, July 2, 2010
Is Another Wave of Biotech M&A On The Way?
There is an old joke among sell-side research analysts that if you are going to make predictions, you should make a lot of them to increase your odds that you will make at least a few correct guesses. With that in mind, I am predicting that we are going to start seeing a wave of acquisitions in the biotech space as larger companies need to recharge their pipelines and better leverage their infrastructure and smaller companies find it increasingly onerous to launch drugs on their own.
Sanofi Goes for the Esoteric
Sanofi-aventis (NYSE:SNY) announced a relatively small deal on Wednesday, telling investors that the company is buying privately-held TargeGen for $75 million in cash. Should TargeGen's compounds hit certain milestones (in other words, if the drugs work), the payout could increase to up to $560 million.
For the full piece, please go to:
http://stocks.investopedia.
Sanofi Goes for the Esoteric
Sanofi-aventis (NYSE:SNY) announced a relatively small deal on Wednesday, telling investors that the company is buying privately-held TargeGen for $75 million in cash. Should TargeGen's compounds hit certain milestones (in other words, if the drugs work), the payout could increase to up to $560 million.
For the full piece, please go to:
http://stocks.investopedia.
Wednesday, June 30, 2010
What Ails Amgen?
Biotech giant Amgen (Nasdaq:AMGN) may not be considered a pharmaceutical company yet, but the market is certainly treating it like one. Whether you consider the P/E ratio, the price-book, price-cash flow, or EV/EBITDA ratios, Amgen trades more or less in line with the likes of Pfizer (NYSE:PFE), Lilly (NYSE:LLY) and GlaxoSmithKline (NYSE:GSK) than Celgene (Nasdaq:CELG) or Genzyme (Nasdaq:GENZ).
This would be all well and good if Amgen was just another typical big-cap pharmaceutical company. Though Amgen does have some issues in common, I think the differences are more significant than the similarities. Most significantly, it looks as though the market is assuming that Amgen is going to grow at a pace similar to most of these large companies (which is to say, "not much"), and this is where the stock could ultimately outperform.
The full article can be read at:
http://stocks.investopedia.
This would be all well and good if Amgen was just another typical big-cap pharmaceutical company. Though Amgen does have some issues in common, I think the differences are more significant than the similarities. Most significantly, it looks as though the market is assuming that Amgen is going to grow at a pace similar to most of these large companies (which is to say, "not much"), and this is where the stock could ultimately outperform.
The full article can be read at:
http://stocks.investopedia.
Tuesday, June 22, 2010
Another Partnership For Alnylam
One of my favorite biotechs (and one that I own), Alnylam Pharmaceuticals (Nasdaq: ALNY), announced yet another partnership tied to its microRNA/RNAi technology.
Tuesday morning, Alnylam announced that Sanofi-Aventis (NYSE: SNY) had formed a research and development partnership with Regulus Therapeutics. Regulus is a 50/50 joint venture between Alnylam and antisense pioneer Isis Pharmaceuticals (Nasdaq: ISIS). As part of the three-year deal, Sanofi is sending a $25 million initial payment to Regulus, and Sanofi will pay for all of the R&D during the deal. Sanofi also has the option to extend the deal for an additional two years, and could send as much as $750 million to the partnership if various development milestones are met (that's a BIG if, and predicated on multiple clinical successes for multiple compounds). The deal may also include a $10M equity investment in Regulus if the parties can agree to a price.
The deal will initially cover the potential use of microRNA for the treatment of fibroids (four different targets), but could expand even further.
Now, partnerships are nothing new for Alnylam (nor Regulus, as there's also a deal in place with Glaxo). The company already had lucrative deals with the likes of Roche, Novartis, and Takeda. That Big Pharma validation is certainly part of why Alnylam is considered the leader in RNAi, and the company has an impressive amount of IP to back up its promise (over 300 patents to date).
This isn't the time or the post where I'm going to go into detail on why I like Alnylam. But I will say this is one of the most interesting biotechs I've seen in a long, long time and while there is nothing like a "sure thing" in biotech, I'm actually allowing myself to get a little excited about the potential of this one. Then again, I once thought the same thing about Isis and although I profited from my ownership in those shares, that never worked out as I had hoped.
Disclosure: I own shares of Alnylam
Tuesday morning, Alnylam announced that Sanofi-Aventis (NYSE: SNY) had formed a research and development partnership with Regulus Therapeutics. Regulus is a 50/50 joint venture between Alnylam and antisense pioneer Isis Pharmaceuticals (Nasdaq: ISIS). As part of the three-year deal, Sanofi is sending a $25 million initial payment to Regulus, and Sanofi will pay for all of the R&D during the deal. Sanofi also has the option to extend the deal for an additional two years, and could send as much as $750 million to the partnership if various development milestones are met (that's a BIG if, and predicated on multiple clinical successes for multiple compounds). The deal may also include a $10M equity investment in Regulus if the parties can agree to a price.
The deal will initially cover the potential use of microRNA for the treatment of fibroids (four different targets), but could expand even further.
Now, partnerships are nothing new for Alnylam (nor Regulus, as there's also a deal in place with Glaxo). The company already had lucrative deals with the likes of Roche, Novartis, and Takeda. That Big Pharma validation is certainly part of why Alnylam is considered the leader in RNAi, and the company has an impressive amount of IP to back up its promise (over 300 patents to date).
This isn't the time or the post where I'm going to go into detail on why I like Alnylam. But I will say this is one of the most interesting biotechs I've seen in a long, long time and while there is nothing like a "sure thing" in biotech, I'm actually allowing myself to get a little excited about the potential of this one. Then again, I once thought the same thing about Isis and although I profited from my ownership in those shares, that never worked out as I had hoped.
Disclosure: I own shares of Alnylam
There Is Life After Death, At Least In Biotech
Crushing disappointment is not an uncommon occurrence in the stock market, but it is practically commonplace in the biotech sector. For every Gilead Sciences (Nasdaq: GILD) or Celgene (Nasdaq: CELG), there are many companies whose compounds fail and whose stocks wither away to mere penny prices.
That said, biotech may also be one of the resilient sectors you can find. So long as you still have a few compounds (or a few ideas) and enough cash, you will get a second chance. And if that second chance works out, you will find the market is more than willing to let bygones be bygones.
For the full column, please go to:
http://stocks.investopedia.
That said, biotech may also be one of the resilient sectors you can find. So long as you still have a few compounds (or a few ideas) and enough cash, you will get a second chance. And if that second chance works out, you will find the market is more than willing to let bygones be bygones.
For the full column, please go to:
http://stocks.investopedia.
Thursday, June 17, 2010
Bringing Biotech To The Barnyard
Human genomics and genetic analysis gets a great deal of attention from investors and journalists. That attention is well-deserved, as a single cancer drug can be worth as much as $100,000 per year per patient. Clearly, that provides ample incentive for major drug companies to invest heavily in genomic equipment in the hopes of developing more effective drugs.
By no means is it just a pharmaceutical opportunity, either. Myriad Genetics (Nasdaq:MYGN) has built an attractive niche in gene-based cancer diagnostics, and larger players like Abbott Labs are also delving deep into molecular and genome-based diagnostics.
But why should people have all the fun? The cattle industry alone is worth about $80 billion a year in theUnited States
You can read the full piece at:
http://stocks.investopedia.
By no means is it just a pharmaceutical opportunity, either. Myriad Genetics (Nasdaq:MYGN) has built an attractive niche in gene-based cancer diagnostics, and larger players like Abbott Labs are also delving deep into molecular and genome-based diagnostics.
But why should people have all the fun? The cattle industry alone is worth about $80 billion a year in the
You can read the full piece at:
http://stocks.investopedia.
Friday, May 28, 2010
What ASCO Can Tell You About Biotechs (Pt 3 of 3)
Although this article shares the same two intro paragraphs as the other two ASCO pieces, it discussing a whole separate list of biotechs. I promise!
One of the major biotech events of the year is fast approaching. The annual meeting of the American Society of Clinical Oncology (ASCO) will take place inChicago Woodstock Woodstock
Ahead of the meeting, ASCO releases a list of abstracts that scientists and companies will present. In some cases, these abstracts give away at least most of the story (efficacy, safety, etc.), while other abstracts are embargoed until the meeting itself. In any case, investors can still look forward to follow-up data (abstracts are submitted well ahead of the meeting) and often the amount of attention garnered by a presentation reflects overall interest in the compound.
Here we present some of the companies presenting abstracts at ASCO.
For the full article, please go to:
http://stocks.investopedia.com/stock-analysis/2010/What-ASCO-Can-Tell-You-About-Biotechs-CELG-DCTH-RHHBY-ZIOP-ZGEN0528.aspx
One of the major biotech events of the year is fast approaching. The annual meeting of the American Society of Clinical Oncology (ASCO) will take place in
Ahead of the meeting, ASCO releases a list of abstracts that scientists and companies will present. In some cases, these abstracts give away at least most of the story (efficacy, safety, etc.), while other abstracts are embargoed until the meeting itself. In any case, investors can still look forward to follow-up data (abstracts are submitted well ahead of the meeting) and often the amount of attention garnered by a presentation reflects overall interest in the compound.
Here we present some of the companies presenting abstracts at ASCO.
For the full article, please go to:
http://stocks.investopedia.com/stock-analysis/2010/What-ASCO-Can-Tell-You-About-Biotechs-CELG-DCTH-RHHBY-ZIOP-ZGEN0528.aspx
Thursday, May 27, 2010
ASCO - A Big Deal For Biotechs (Pt 2)
This is the second of three articles previewing the ASCO meetings in Chicago next week.
One of the major biotech events of the year is fast approaching. The annual meeting of the American Society of Clinical Oncology (ASCO) will take place inChicago Woodstock Woodstock
Ahead of the meeting, ASCO releases a list of abstracts that scientists and companies will present. In some cases, these abstracts give away at least most of the story (efficacy, safety, etc.), while other abstracts are embargoed until the meeting itself. In any case, investors can still look forward to follow-up data (abstracts are submitted well ahead of the meeting), and often the amount of attention garnered by a presentation reflects overall interest in the compound. (For more, see Stocks On Drugs: What It Takes To Get High.)
To read the full text of Part 2, please continue on to:
http://stocks.investopedia.com/stock-analysis/2010/ASCO---A-Big-Deal-For-Biotechs-BMY-ARIA-ARQL-KERX-AEZS-NKTR-VNDA0527.aspx
One of the major biotech events of the year is fast approaching. The annual meeting of the American Society of Clinical Oncology (ASCO) will take place in
Ahead of the meeting, ASCO releases a list of abstracts that scientists and companies will present. In some cases, these abstracts give away at least most of the story (efficacy, safety, etc.), while other abstracts are embargoed until the meeting itself. In any case, investors can still look forward to follow-up data (abstracts are submitted well ahead of the meeting), and often the amount of attention garnered by a presentation reflects overall interest in the compound. (For more, see Stocks On Drugs: What It Takes To Get High.)
To read the full text of Part 2, please continue on to:
http://stocks.investopedia.com/stock-analysis/2010/ASCO---A-Big-Deal-For-Biotechs-BMY-ARIA-ARQL-KERX-AEZS-NKTR-VNDA0527.aspx
Wednesday, May 26, 2010
A Big Deal For Biotechs - ASCO
One of the major biotech events of the year is fast approaching. The annual meeting of the American Society of Clinical Oncology (ASCO) will take place in Chicago Woodstock Woodstock
Ahead of the meeting, ASCO releases a list of abstracts that scientists and companies will present. In some cases, these abstracts give away at least most of the story (efficacy, safety, etc.), while other abstracts are embargoed until the meeting itself. In any case, investors can still look forward to follow-up data (abstracts are submitted well ahead of the meeting) and oftentimes the amount of attention garnered by a presentation reflects overall interest in the compound.
Here we present some of the companies presenting abstracts at ASCO.
For the full article, please continue on:
http://stocks.investopedia.com/stock-analysis/2010/A-Big-Deal-For-Biotechs---ASCO-AMGN-PFE-CLDX-PCYC-ITMN0526.aspx
Ahead of the meeting, ASCO releases a list of abstracts that scientists and companies will present. In some cases, these abstracts give away at least most of the story (efficacy, safety, etc.), while other abstracts are embargoed until the meeting itself. In any case, investors can still look forward to follow-up data (abstracts are submitted well ahead of the meeting) and oftentimes the amount of attention garnered by a presentation reflects overall interest in the compound.
Here we present some of the companies presenting abstracts at ASCO.
For the full article, please continue on:
http://stocks.investopedia.com/stock-analysis/2010/A-Big-Deal-For-Biotechs---ASCO-AMGN-PFE-CLDX-PCYC-ITMN0526.aspx
Thursday, May 13, 2010
Will Adaptive Design Change the BioPharma World?
I wrote the following for Investopedia, and it was published today.
I'm actually pretty interested in seeing what, if any, reaction I get to this. I really do believe this is one of the bigger ideas that could emerge in biopharma over the next few years, but it is an idea that you scarcely hear about outside of occasional panels and forums at industry conferences and meetings.
I hope you find it interesting.
Every so often a good idea comes out way ahead of its time. Fuel cells actually predate the gasoline engine, the Apple (Nasdaq:AAPL)Newton
Adaptive clinical trial design may ultimately belong on this list as well. Although the idea of changing pharmaceutical drug trials in response to data generated within the trial has been around for at least 10 years, the idea may finally be on the cusp of being realized. Should this concept become more commonplace, it could be a major step forward for biotechnology and pharmaceutical companies.
Read the full column at:
http://stocks.investopedia.com/stock-analysis/2010/Will-Adaptive-Design-Change-The-BioPharma-World-AMGN-GILD-ITMN-EXEL-LLY-PFE-PRXL0513.aspx
I'm actually pretty interested in seeing what, if any, reaction I get to this. I really do believe this is one of the bigger ideas that could emerge in biopharma over the next few years, but it is an idea that you scarcely hear about outside of occasional panels and forums at industry conferences and meetings.
I hope you find it interesting.
Every so often a good idea comes out way ahead of its time. Fuel cells actually predate the gasoline engine, the Apple (Nasdaq:AAPL)
Adaptive clinical trial design may ultimately belong on this list as well. Although the idea of changing pharmaceutical drug trials in response to data generated within the trial has been around for at least 10 years, the idea may finally be on the cusp of being realized. Should this concept become more commonplace, it could be a major step forward for biotechnology and pharmaceutical companies.
Read the full column at:
http://stocks.investopedia.com/stock-analysis/2010/Will-Adaptive-Design-Change-The-BioPharma-World-AMGN-GILD-ITMN-EXEL-LLY-PFE-PRXL0513.aspx
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