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 […]
September 18 Biotech Update
Seems like a mixed day for the sector with the broader markets offering a nice background for gains but the biotech sector is not really rallying as you would expect. It is still early and I am not sure there is too much to read into this but one would prefer to see a more […]
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 […]
May 12 Biotech Update- Gearing Up for ASCO
We are getting into the ASCO frenzy and so it is not surprising that biotechs caught a bid this morning. It could just be coincidence or it could be yet another false start but we have been basing for a little while, so perhaps this is something more significant. The next leg higher will start […]
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 […]
June 3- EOD
Happy mid-ASCO (although most of the data is already presented). Some interesting ASCO and, surprisingly, non-ASCO stories. 1. I added to my SGEN position today (at $33.67). It has been under pressure recently and I’ve been looking to add over the summer in anticipation of HL data at ASH. I am intimately aware of the […]
VVUS – PDUFA approaching, company revving Branding & Marketing
Vivus’s (VVUS), a specialty pharmaceutical company, had faced many setbacks with it’s drug candidate, Qnexa, an investigational treatment for obesity, obstructive sleep apnea and diabetes. In October 2010, Vivus received a Complete Response Letter from the FDA. In March of 2011, several studies were published demonstrating teratogenicity with one of Qnexa’s main ingredients, topiramate. Despite […]
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. […]
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 […]
VVUS – Vivus & the FDA; Understanding the Advisory Committee
Our Previous Coverage: Initial Report – 12/16/11 Quick Update 1 – 01/09/12 Last week, the FDA released the briefing documents for an upcoming Advisory Committee meeting set to discuss Vivus’s Qnexa, an investigational compound for the treatment of obesity. Our team combed through over 400 pages of material, in an effort to synthesize this data […]
Upcoming FDA Decisions and Advisory Panels
To help save everyone some time, we went ahead and rounded up the upcoming FDA PDUFA dates and FDA Advisory Committees. We will have trade ideas and opinions on some of these events in the near future. We have highlighted some of those which we feel are the biggest importance to the market with asterisks(*). […]
VVUS – Quick Update – Vivus alters NDA for Qnexa, changes REMS
Vivus Pharmaceuticals (NASDAQ:VVUS) reached an agreement today with the FDA, to alter both it’s REMS and Label for obesity drug candidate, Qnexa. Previous Proposed Label Management took a very conservative approach when filing the initial NDA. Given questions about teratogencity of topiramate, one of the active ingredients in Qnexa, Vivus’s management proposed a label that […]
VVUS – Vivus Pharmaceuticals – Initiating Covereage – Neutral
Vivus (VVUS), is a specialty pharmaceutical company with two lead product candidates that are facing a regulatory decision within the next 6 months. Besides two PDUFA dates, VVUS also has an FDA Advisory Committee Meeting and results from a key study, dubbed FORTRESS, due out in the coming days. The most anticipated drug candidate […]
