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 […]

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 […]

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 […]

INCY – Initiate Coverage on Incyte

Incyte Pharmaceuticals (INCY) Initiating Coverage: Incyte Pharmaceuticals is a small biotech company focused on developing treatments for cancer and inflammatory disorders. Lead compound Ruxolitinib (INCB18424) is awaiting FDA approval for the treatment of Myelofibrosis (MF) with an expected decision date on December 3rd. Ruxolitinib is also recruiting patients in a global Phase III study for […]

Run Biologics- The JAKs Are Coming

A new class of drugs targeting the JAK kinases is set to challenge today’s biggest selling biologics for the treatment of arthritis and other inflammatory diseases. Heading this class is Pfizer’s tofacitinib; this potent, but relatively un-selective JAK inhibitor demonstrated positive results in five pivotal trials earlier this year. Pfizer intends on filing for marketing […]

Opioid Pain Drug by Pfizer and Acura approved by FDA

The FDA has granted approval for an abuse-resistant opioid formulation made by Acura Pharmaceuticals (NASDAQ:ACUR) and Pfizer (NYSE:PFE).  The drug is a reformulation of immediate release oxycodone.  The trade name of the drug will be OXECTA, it was previously known as ACUROX.  Pfizer’s media relations said that they can provide more information once the press […]

Good News For Pfizer Oral RA Drug

Pfizer announced results from two clinical trials of its JAK inhibitor, tofacitinib for rheumatoid arthritis at the European League Against Rheumatism (EULAR) in London on Wednesday. One study, a Phase III trial called ORAL Sync compared tofacitinib plus methotrexate to methotrexate alone in 792 patients with moderate to sever active RA who had an inadequate […]

Pfizer moves forward with Pristiq for Hot Flashes

Last week, Pfizer (NYSE:PFE) announced that they had presented results from sub-study of Pristiq (desvenlafaxine) at the 59th annual clinical meeting of the American College of Obstetricians and Gynecologists (ACOG). The results were from a large, phase 3 trial, that sought to elaborate the safety and efficacy of Pristiq for the use in hot flashes […]