The 2012 ASCO Genitourinary Cancers Symposium from February 2-4, 2012. The conference is broken down into 3 days focusing on three main areas: Thursday appears dedicated to prostate cancer, Friday is mostly related to urothelial cancers(penile, urethral, urothelial, and testicular), and Saturday is dedicated to kidney cancer. Abstracts will be released on Tuesday, January 31, […]
Anticipated EMA decisions in the first half of 2012
Following our post on upcoming FDA decisions/panel, we wanted to do the same but for European Medicines Agency (EMA) decisions. As you will see, most of the events listed below just have an estimated date by which we will hear an update. This is largely because the way drugs are approved in the EU is […]
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(*). […]
Biotech catalysts at two upcoming medical conferences
We want to take a moment to highlight two upcoming oncology focused medical conferences that will showcase data that represent potential catalysts for several biotech companies we’re tracking. First up, we have the 2012 ASCO Gastrointestinal Cancers Symposium from January 19-21, 2012. This conference will be focused on developments in the treatment of cancers of […]
AVEO – Quick take on top-line data
AVEO Pharmaceuticals(NASDAQ: AVEO) kicked off the 2012 trading year with news from their Phase 3 trial, TIVO-1. AVEO announced that Tivozanib had demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in TIVO-1, a global, randomized Phase 3 clinical trial evaluating the efficacy and safety of Tivozanib compared to Nexavar(sorafenib) in patients […]
AVEO – Initiating Coverage
Overview AVEO Pharmaceuticals(NASDAQ: AVEO) is a clinical stage cancer therapeutics company with 2 main compounds in development. AVEO’s lead candidate, Tivozanib(AV-951), is designed to block the VEGF pathway by inhibiting all three VEGF receptors(1,2,3). Tivozanib is currently being tested in a pivotal Phase 3 clinical trial called TIVO-1, which is comparing Tivozanib to Onyx’s sorafenib […]
ARQL – Initiating Coverage
ArQule Inc.(NASDAQ: ARQL) is a mid-stage small molecule drug company that specializes in the development of tyrosine kinase inhibitors(TKIs). Their in-house drug development program, ArQule Kinase Inhibitor Platform (AKIP™), produced their lead product candidate, ARQ197, a selective small molecule inhibitor of the c-MET receptor tyrosine kinase. With Tivantinib entering Phase 3 trials in non-small cell […]
Clinical data expected by end of 2011
This post is meant to highlight some of the key data that is expected by year’s end 2011. We have highlighted some of those catalysts which should have a significant impact on price. We have some forthcoming coverage on ONXX, CELG, and ACHN. Data expected at the annual meeting of the American Society of Hematologists, […]
Regulatory catalysts expected by end of 2011
This post is meant to highlight some of the key regulatory decisions that are expected by year’s end 2011. We have highlighted some of those catalysts which should have a significant impact on price. We should have some coverage/ideas coming up for some of these that we haven’t already written about. FDA Decisions or FDA […]
MNTA – Quick update on Momenta
Yesterday, we saw Momenta Pharmaceuticals (NASDAQ: MNTA) gain 12% on above average volume following some subtle court news that was not picked up by any news providers. Following Momenta’s win in court on October 28th for a preliminary injunction against Amphastar Pharmaceuticals and Watson Pharmaceuticals (NYSE: WPI) over their generic Lovenox, Amphastar filed an emergency […]
ONXX – Trade Idea
Onyx Pharmaceuticals(ONXX) submitted their NDA for Carfilzomib to the FDA under the accelerated approval process on 9/28/11 and are seeking a 6-month priority review. At the earliest, they could be hearing back from the FDA on Saturday, November 26th. Typically, the FDA will notify the sponsoring company within 60 days as to whether or not […]
Clinical database updates
We got a chance over the past weekend to update the clinical database. After doing so, we felt the need to quickly highlight some potential catalysts. These events are likely to take place in the next 6 months and several companies have multiple upcoming value creating events. (To continue reading, sign up here or subscribers should […]
INCY – Incyte’s Jakafi post-approval conference call – Live Blog
INCY post-approval conference call
MNTA: Initiating Coverage
Overview Momenta Pharmaceuticals(NASDAQ:MNTA) is a biotechnology company that specializes in the development of complex generic and novel drugs. Momenta specializes in the detailed structural characterization and engineering of complex sugars and proteins. Momenta was the first company to receive approval for a generic Lovenox, which is low molecular weight heparin, required very precise characterization of […]
ALIM & PSDV – Trade Review
We fully expected that pSivida(NASDAQ: PSDV) and Alimera Sciences(NASDAQ:ALIM) will receive another Complete Response Letter for ILUVIEN in the treatment of diabetic macular edema (DME). We see little reason for the FDA to approve this NDA, based on the safety and efficacy data. Both PSDV and ALIM will be hard up for cash if ILUVIEN […]
