The sector was relatively weak yesterday and did not start this morning particular strong. I still am noticing the large cap lagging trend that has been going on for awhile. Is this simply a function of the lack of near term catalysts, increasing bearishness on the large caps, investors chasing returns lower on the capital […]
March 6 Biotech Update
It seems like every day I write this week is a weak start to the morning. It is not surprising that the sector is pulling back after the run yesterday and the renewed bubble chatter. Every run in the sector the past two years has brought out the bubble chatter and every time it was […]
March 4 Biotech Update
Another weak start to the sector, which seems to be a developing theme but the whole market is down so I would not read too much into it. It still looks a lot like a consolidation of the recent move higher both for biotechs and the broader markets. It might not be a bad time […]
March 3 Biotech Update
The market is weaker today and it is bringing down the sector, although it appears that biotechs are underperforming the broader market. It does not appear that this underperformance is concentrated in any market cap group or therapeutic area and simply looks like broadly hitting the sell button. Not exactly sure why the selling was […]
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 […]
Catalyst Watch – Vol. 2, Edition 25 (8/26/14)
Below are current tactical and strategic thoughts on approaching FDA and clinical trial catalysts for select names. Estimates, values and views are as of the date published (or are noted), are subject to potential future, pre-catalyst revision and are not intended as investment recommendations. Please read our Disclaimer: (1) Catalyst Watch List: AEZS: PDUFA is […]
Catalyst Watch – Vol. 2, Edition 23 (7/29/14)
Below are current tactical and strategic thoughts on approaching FDA and clinical trial catalysts for select names. Estimates, values and views are as of the date published (or are noted), are subject to potential future, pre-catalyst revision and are not intended as investment recommendations. Please read our Disclaimer: (1) Catalyst Watch List: AEZS: I continue […]
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 […]
Notes from JP Morgan Healthcare Conference (Monday/Tuesday session)
As we go into the 3rd day of the JP Morgan Healthcare Conference, we wanted to provide some highlights and notes from the first 2 sessions. I tried to keep them as concise as possible. Day 1 Clearly, Celgene Corp.(NASDAQ: CELG) came firing out of the gates by announcing strong financial guidance. This included in-line […]
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, 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 […]
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 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 […]
Orexigen’s Contrave- Making Waves Beyond Obesity Drugs
The success of Orexigen’s weight loss drug, Contrave, with the FDA advisory panel highlights an important area in drug development- repositioning. Orexigen accomplished this by combining the off-patent drugs bupropion and naltrexone in a novel single pill fixed dose formulation. Bupropion is an antidepressant and smoking cessation drug while naltrexone is used to treat alcoholism […]
Orexigen’s Contrave Receives Panel Backing- Great News For Vivus
In a shock to watchers of recent developments in the area of weight loss drugs, the FDA panel of expert advisors voted 13 to 7 recommending the approval of Contrave from Orexigen. They also voted 11 to 8 with one member abstaining, that a long-term cardiovascular study should be conducted after approval of the drug. […]
