We finally got a merger Monday and this should boost the sector. So far the sector is doing well in a generally bad market environment and hope this continues. There are certainly some non-sector related risks to the market that would hit biotech but as long as they remain muted, we should be able to […]
November 15 Biotech Update
Today is an important day for the sector. We are at very long term support (the 200 week MA) that has rarely been breached (occasionally but never in a sustained manner). At levels that should provide some support we get some partnership news that is positive for SMID (it seems like partnerships are the new […]
February 25 Biotech Update
I am back but have not really followed the market the past couple of days. My sense is that it has been relatively weak and could be setting up for a near term pullback. That is likely healthy in that the sector has had a good run and is getting a little stretched. Outside of […]
December 29 Biotech Update
The sector has recovered from the brutal sell off in no small part related to a recovery in GILD. As I noted last week, the sector needs GILD to stabilize/recover to move higher and so I am not surprised to see biotechs move higher in sympathy with GILD. Why is there such a relationship? GILD […]
October 30 Biotech Update
Sort of an up and down morning to start but the sector seems to be outperforming a little, perhaps on the back of good BMY data. At this point the market is in a show me state with both the bulls and bears expecting the next move to validate their view and positions. I still […]
June 11 Biotech Update
Another relatively slow summer day in the market in terms of trading but the sector seemed to outperform the broader market. Even with that marginal outperformance, I would not read anything new into in that I still believe that the macro is going to drive the next move. That being said I would not be […]
October 15- EOD
While this may surprise you (not) but it was another macro driven day (I know you are probably getting as tired of reading that as I am of writing it). Volume also seems to be drying up as investor simply sit on their hands and wait for Washington to get off of their hands. Despite […]
September 16- EOD
It was a strong day in the market but a weak day in biotech. That being said I think there was a definite pattern in that the large caps and biopharmas seemed to outperform (although they were still weaker than the market) than the mid- and small- caps. In my mind, I read that as […]
September 16- EOD
It was a strong day in the market but a weak day in biotech. That being said I think there was a definite pattern in that the large caps and biopharmas seemed to outperform (although they were still weaker than the market) than the mid- and small- caps. In my mind, I read that as […]
September 16- EOD
It was a strong day in the market but a weak day in biotech. That being said I think there was a definite pattern in that the large caps and biopharmas seemed to outperform (although they were still weaker than the market) than the mid- and small- caps. In my mind, I read that as […]
August 29- EOD
We got a trickle of some interesting biotech news but still nothing dramatic. I suspect that the pace will increase in September as the summer ends and the fall healthcare conference season begins. 1. PCYC announced the acceptance of the NDA for previously treated mantle cell lymphoma (MCL) and previously treated chronic lymphocytic leukemia (CLL)/small […]
VVUS – Understanding the Upcoming PDUFA
Vivus’s July 17th PDUFA date is quickly approaching. After the FDA Advisory Committee voted strongly in favor of approving Qnexa, for the treatment of obesity, mostly all pundits and analyst have all but claimed victory for Vivus’s upcoming PDUFA date. We feel that overall, Qnexa has received significantly more positive commentary secondary to a meaningful […]
ARNA – Quick Update on Arena’s upcoming PDUFA date
Arena’s June 27th PDUFA date is quickly approaching. After the FDA Advisory Committee voted strongly in favor of approving Lorcaserin, for the treatment of obesity, mostly all pundits and analyst have all but claimed victory for Arena’s upcoming PDUFA date. We feel that despite modest efficacy, Lorcaserin has a high degree of likelihood for approval. […]
A flurry of upcoming data before the end of June
With the close of the first half of 2012 upon us, we wanted to highlight some of those expected to report data or regulatory decisions before the end of June. Dynavax (NASDAQ: DVAX) is expected to report whether the FDA will designate priority review upon their Biologics License Application (BLA) for HEPLISAV. They are seeking […]
ARNA, VVUS & OREX – Update after Lorcaserin AdCOM
Yesterday, the FDA Advisory Committee voted strongly in favor of approving Lorcaserin, for the treatment of obesity. Previously, our group felt that ARNA’s Lorcaserin along with OREX’s Contrave would eventually gain regulatory approval, but that there would be some delay. In the case of ARNA, we were impressed at how eager the Advisory Committee was […]
ARNA – Quick take on FDA Adcom
Our coverage of the anti-obesity sector continues. Yesterday, the FDA released the briefing documents regarding Arena’s application for Lorcaserin. Lorcaserin, or Lorqess, is a novel therapeutic candidate for treatment of obesity. Brief History: In 2010, Arena submitted the NDA for Lorcaserin, a subsequent AdCom voted against the application, five on the roster voted for the […]
VVUS, OREX, ARNA – Understanding the Advisory Committee
Playing VVUS, OREX, ARNA through FDA Adcomm and Qnexa PDUFA Over the past several months, these three companies, with their respective late-stage anti-obesity drug candidates, have experienced a considerable increase in volatility and share price, due in part to new regulatory revelations regarding clinical pathways to regulatory approval. We believe there will continued volatility leading […]
