With the JP Morgan Healthcare Conference wrapped up, I wanted to highlight some notes from the Wednesday session. I tried to keep them as concise as possible. We will say that we did see a lot of material that will keep up us busy for the year. You can find the webcasts to any of […]
EXEL – Looking for Direction Ahead of the PDUFA date
Exelixis (NASDAQ: EXEL) On 5/30/12, Exelixis submitted their NDA for Cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). They were subsequently granted priority review with a PDUFA date set for 11/29/12. Recently, the FDA announced they had planned to hold an Advisory Committee to discuss this […]
Updates out of ESMO12
The European Society for Medical Oncology (ESMO) Congress 2012 kicked off this weekend and goes until October 2nd(Tuesday). Abstracts with data for those presentations that have already occurred can be viewed and searched here(link). We did get several updates from companies that we would like to review. First up is Threshold Pharmaceuticals (NASDAQ: THLD). On Saturday, they presented […]
Upcoming events for EXEL, ARQL, CLDX
This is the second installment in our series about upcoming events across the biotech sector(see our 1st piece). As we have said before, this fall should be full of meaningful data catalysts for biotech companies. In our next segment, we will take a look at a few larger biotech companies and what we will be […]
ESMO12 Abstracts of interest
The European Society for Medical Oncology (ESMO) Congress 2012 kicks off on September 28th thru October 2nd. Abstract titles are currently able to be viewed and searched here(link), but no other descriptive information is available. Abstracts will be available before-hand on September 17th, with late-breaking abstracts coming during the Congress. Synta Pharmaceuticals (NASDAQ: SNTA) Several sources […]
EXEL – In A Consolidation Mode
EXEL “Exelixis” had an impressive uptrend starting in June 2012, anticipating the FDA reply for the NDA filling & priority review, starting from the $4.40 area, reaching the $6.95 point on the day of the announcement that the FDA accepted its potential medullary thyroid cancer (MTC) treatment, cabozantinib, for priority review , which is shorter […]
Upcoming FDA Decisions
We will have several regulatory decisions expected this week, some more important than others. This coming week got slightly tamer with the FDA’s approval decision for Carfilzomib on Friday for Onyx and Ligand. Horizon Pharmaceuticals (NASDAQ: HZNP) has a PDUFA date of Thursday, July 26, 2012 for LODOTRA(delayed-release low-dose prednisone), for the treatment of rheumatoid […]
EXEL – Post-ASCO thoughts on Exelixis
This post will be a follow up on what was previously said[link] about Exelixis (NASDAQ: EXEL) at ASCO 2012. Their key presentations in castration-resistant prostate cancer (CRPC) took place on Monday/Tuesday of the conference. Exelixis provided a link to all of their posters and presentations at the conference[link] and held an investor briefing[link]. Cabo for […]
Some thoughts on data at ASCO 2012 (Days 1,2)
Medivation (NASDAQ:MDVN), Johnson & Johnson (NYSE: JNJ) and Dendreon (NASDAQ: DNDN) are woven in a closely watched battle in prostate cancer. JNJ’s AA-302 has been chopped up many ways and there are some weird things that come to mind. We don’t think the AA-302 was all that damaging to Dendreon’s Provenge, but the headline risk […]
EXEL – On Overall Survival And Bone Scans
Exelixis’ abstract of its final data from its pivotal Phase III study of cabozantinib in medullary thyroid (MTC) cancer was released on May 16th during the ASCO abstracts data dump. Investors already knew from top-line data released October 2011 that the drug was highly active and met the primary endpoint of progression free survival (PFS) […]
Quick commentary on ASCO12 abstracts
Last night we had the release of the abstracts for the 2012 Annual Meeting of the American Society of Clinical Oncology(ASCO12 for short). It’s quite the data deluge. Below is some quick commentary on my read on abstracts related to several companies. Onyx(NASDAQ: ONXX) and Seattle Genetics (NASDAQ: SGEN) both had interesting datasets that we […]
ASCO 2012: American Society of Clinical Oncology Preview Part 2
The 2012 American Society of Clinical Oncology (ASCO) Annual Meeting[link] will take place from June 1st to 5th in Chicago. This is the world’s largest meeting of oncology professionals where some of the industry’s most important data presentations will take place. With conferences like these, come the abstracts releases for presentations; this year abstracts will […]
EXEL – Exelixis Update November 2, 2011- FDA Denies SPA
Exelixis Update November 2, 2011- FDA Denies SPA After hours on Halloween, Exelixis announced it could not reach an agreement with the FDA for the design of its pivotal ‘306 trial of cabozantinib in metastatic castrate resistant prostate cancer (mCRPC) four months after its initial application. That said, the company has decided to initiate the […]
EXEL – Exelixis Update And Catalyst Report
Exelixis Update and Catalyst Report Overview: Lots going on at Exelixis end of this year. The company gave an overview of top-line data from recently announced successful EXAM medullary thyroid cancer (MTC) trial. As previously mentioned, patients on XL184 (cabozantinib) had progression free survival (PFS) of 11.2 months compared to 4.0 months for placebo. The […]
EXEL – Initiating Coverage on Exelixis
(Updated October 25th- MTC trial meets primary endpoint) Overview: Exelixis is a developmental stage oncology company with a single wholly owned compound XL184, or “cabozantinib” in Phase III trials for medullary thyroid carcinoma (MTC). This is a double blind placebo controlled trial with a final endpoint of progression free survival (PFS) initiated in 2008 after […]
Exelixis- Why The Holdup?
Why so long to file an SPA (Special Protocol Assessment), investors wonder. An SPA in itself is not necessary, but sets up agreed upon protocols and endpoints of a pivotal trial that will be used to file for a new drug application (NDA). Having one in place may give the trial sponsor more confidence while […]
