Not a particularly news rich day but the sector seemed to continue its momentum from yesterday and seemed to outperform the general market with a lot of green on a red day. 1. Well, it looks like JNJ is tossing another wrench in ECYT trials with more doxil supply problems. ECYT noted that they have […]
July 29- EOD
We finally had a major biotech merger but it was not one that got people excited as volumes and price action in biotech were neutral to negative for most of the day. Despite the lack of enthusiasm this was actually a pretty interesting day from the news front, so I will quickly touch on a […]
July 16- EOD
Seemed like a slow news day as the markets pulled back to consolidate some of the recent moves. Biotechs were not immune to the move, although some clearly performed better than others. 1. EPZM has shown incredible strength since the IPO. While I like this company’s technology and would like to own some shares, it […]
July 15- EOD
Well, there was not a lot of news out there in biotech land but oddly there is a lot I want to talk about and will work through it over the next couple of days. 1. ARIA Iclusig prescriptions came in weak again with new prescriptions down 26% and only a 9% gain in continuing […]
July 1- EOD
Today was the fallout of the AMGN bid for ONXX. There are a couple of aspects of it that I want to touch on and go a little further than my article this morning. 1. In my article I tried to cover the companies that I thought had the most compelling reasons to be interested […]
June 7- EOD
[This was meant to be posted Friday afternoon but did not seem to go through, so you get a bonus EOD of today] I do not think there is not much out there to add from today. I will touch on a couple of themes but it was generally a bounce back day for the […]
May 21 – End Of Day Biotech Wrap-up
Perhaps it is the start of the summer season but the market seems to have been quite the past couple of days or perhaps I am simply looking at the wrong parts of the market. 1. There were a number of EHA abstracts released today for PCYC and perhaps one of the most important was […]
Busy week ahead for Biotech
This week is going to be particularly heavy on the earnings updates and FDA actions. Below are some of our views on potential updates and major events at biopharmaceutical companies this week. Additionally, the 12th Annual Needham Healthcare Conference takes place this week from 4/30-5/1. Monday, April 29th Main story for Dynavax will be the potential […]
AVEO – An analysis of Aveo’s upcoming advisory committee
(in collaboration with Juan Pedro Rodriguez Serrate) The FDA’s Oncologic Drugs Advisory Committee (ODAC) is slated to review AVEO Oncology (NASDAQ: AVEO) / Astellas Pharmaceuticals’ Tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC) during the morning session of its meeting on May 2, 2013. An FDA decision is expected by Jul […]
Rheumatoid Arthritis Treatments: The Decade Ahead
Rheumatoid arthritis sufferers have seen dramatic improvements in the standard of care over the last 25 years. Prior to the approval of methotrexate (MTX) in 1988, the best that doctors had to offer were NSAIDs and analgesics to manage pain and inflammation. As the first approved disease modifying drug, MTX revolutionized RA treatment and is […]
INCY – Q2 Earnings Call
For the first time since the launch of recently approved myelofibrosis drug Jakafi, Incyte provided revenue guidance for the year – and investors were disappointed. Overview: While Q2 product sales were slightly above expectations at $32.7 million, projected 2012 revenue of between $120 and $135 million were below some analyst estimates of as high as […]
INCY- 12-week RA Results Follow-up
Incyte and partner Eli Lilly presented complete full 12-week results for its JAK inhibitor INCB28050 (LY300904), now known as baricitinib June 8 at EULAR as a late-breaker. A total of 301 subjects with inadequate response to methotrexate (MTX) were enrolled in Eastern Europe, India, Mexico, and the U.S. The trial was run by Lilly. This is a […]
INCY – Outstanding 3-Month RA Data
Data from the 12-week portion of Incyte’s 24-week Phase IIb study in patients with moderate to severe RA were released in an abstract ahead of EULAR today. In this 301 patient trial, patients were randomized to placebo, 1mg, 2mg, 4mg, or 8mg INCB28050 (also known as LY3009104). All endpoints were met for the 4mg and […]
DEPO, SNTS, XNPT, PFE – Update on Q1 Earnings
DEPO – Reaffirming Buy Yesterday, Depomed reported better-than-expected earnings for the first quarter. Gralise revenue was $1.75 million, Glumetza revenue was $9.2 million, Janumet XR was $0.2 million. We are reaffirming our BUY recommendation for this company. We feel that increases in total sales for Glumetza, price increases, and an increase in the percentage revenue […]
DEPO – Quick Update on Depomed’s plan to file NDA for Serada
On Tuesday, Depomed announced that they intend to file an NDA for Serada. At one point, in after hours trading the stock peaked up almost 7%, at which point we cautioned investors, here, to consider selling into this strength. Since then, it seems that the stock price had settled back down pre-news levels until […]
PFE & BMY – Quick Update on Pfizer’s and Bristol’s Apixaban
In the past week Bristol Myers Squibb (NYSE:BMY) and Pfizer (NYSE:PFE) have had two notably regulatory events for Apixiban, or ELIQUIS. On November 25th, the National Institute for Health and Clinical Excellence (NICE) made an unusually rapid decision to adopt and cover Apixaban for use by the state health service in the UK. This […]
ASH Stock Preview
2011 ASH Stock Preview It’s the end of the year, which can mean only one thing- the American Society of Hematology Convention is coming up! ASH is the year’s largest meeting for researchers and investors interested in hematology, or blood cancers. This year’s convention will be held from December 9th through 12th in sunny San […]
PFE & BMY – The anticoagulant market & the Apixaban Catalyst
Background: The market for anti-thrombosis agents is set for dramatic changes. A thrombus is an aggregation of platelets which plays a key part in several life-threatening diseases, such as myocardial infarction, stroke, deep-vein thrombosis, pulmonary embolism, stent thrombosis, as well as other medical conditions. The market for therapies against thrombosis can be broken down simply […]
DEPO, XNPT, PFE – Managed-care to stunt Lyrica, Horizant and Gralise with step-edits
The Neurology and Pain sectors have been very interesting for biotech investors focused over the past year. Xenoport (NASDAQ:XNPT), Depomed (NASDAQ:DEPO), GlaxoSmithKline (NYSE:GSK) and Pfizer (NYSE:PFE) have all had regulatory successes over the past several months. The problem is the regulatory successes haven’t necessarily resulted in financial success for companies and their shareholders. At a […]
DEPO – Buying Opportunity after Serada failure
Earlier in October, Depomed (DEPO), announced results from it’s Phase 3 trial, called BREEZE 3, testing Serada, an extended release gabapentin formulation for the use in post menopausal hot flashes. The trial failed to meet 1 of 4 primary endpoints, and failed to meet its key secondary endpoints. Below is an excerpt from Depomed’s press […]