On Monday, November 5th, abstracts submitted to 2012 Annual Meeting of the American Society of Hematology (ASH) Annual Meeting will be published online. A time has not been released, but we have heard they will be released at 10AM Eastern time. Below are some comments on companies we expect to have a present at the […]
Upcoming events for REGN, MDVN, and BMRN
This is the third installment in our series about upcoming events across the biotech sector(be sure to see our 1st piece and 2nd piece). This time around we want to take a look at some upcoming events at some larger biotech companies and what we will be drivers for them going forward. If there are any companies […]
LGND – Updates from the JMP Securities
The JMP Securities Healthcare Conference was held July 12-13, a rare biotech investor event during the summer doldrums [webcast link and check back at BiotechDueDiligence where I will archive select slides]. We will follow up with reports on Synta Pharma SNTA, Biosante Pharma BPAX, Spectrum Pharma SPPI, Alnylam ALNY and Isis Pharma ISIS, but for now […]
ONXX – Upcoming events at Onyx Pharmaceuticals
Onyx Pharmaceuticals(NASDAQ: ONXX) has a pretty long list of upcoming news that will keep the stock’s momentum following the positive FDA ODAC vote for Kyprolis™ (proposed brand name for carfilzomib) in June. As we said in our blog piece, the briefing documents pointed to a very different FDA stance than what actually transpired. With that […]
CELG ONXX – Lessons in humility courtesy of Celgene and Onyx
First, Onyx Pharmaceuticals (NASDAQ:ONXX) received an unanimous recommendation for approval of Kyprolis™ (proposed brand name for carfilzomib) by the FDA’s Oncologic Drugs Advisory Committee (ODAC) by a vote of 11-0 [with 1 abstention]. This indication will be for patients with relapsed and refractory multiple myeloma who have received at least 2 prior lines of therapy […]
ONXX – Preview of Onyx Pharmaceuticals ODAC
On Monday investors are expecting the FDA’s briefing documents to be posted for Onyx Pharmaceuticals (NASDAQ: ONXX) upcoming Oncologic Drugs Advisory Committee (ODAC) to review their NDA for Krypolis(Carfilzomib) for the treatment of patients with relapsed and refractory multiple myeloma(MM) who have received at least two prior therapies. The ODAC will take place on Wednesday, […]
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 […]
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 […]
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 […]
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 […]