Cornerstone Therapeutics (NASDAQ:CRTX) recently caught our attention following the announcement of an FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) to review their NDA for lixivaptan (CRTX 080) for the proposed indication of the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively. The meeting […]
VNDA – Flash take on Vanda Pharmaceuticals
Vanda Pharmaceuticals (NASDAQ: VNDA) is a pharmaceutical company that carries a certain amount of folklore around it amongst traders. As legend has it, they fell upon hard times following the FDA’s rejection of their Fanapt for schizophrenia in 2008 and faced bankruptcy in 2009. They later re-emerged from bankruptcy, gained FDA approval of Fanapt in […]
A few recent biotech IPO’s
There have been a few recent IPOs from biotech companies that we want to briefly highlight. Some have upcoming data or regulatory decisions that we will be adding to the database shortly. (1) Hyperion Therapeutics (NASDAQ: HPTX), a biotech focused on the treatment of urea cycle disorders and hepatic encephalopathy. Hyperion plans to raise $50 […]
AMRN HZNP – Amarin’s VASCEPA and Horizon’s RAYOS receive FDA approval
Late Thursday afternoon, we learned that both Amarin (NASDAQ: AMRN) and Horizon Pharmaceuticals (NASDAQ: HZNP) separate new drug applications had been approved by the FDA. We have some insight to share on both names. With respect to Horizon, unfortunately, their future is not looking so bright. Rayos is a delayed-release formulation of low-dose prednisone. Prednisone […]
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 […]
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 […]
A flurry of upcoming data before the end of June
With the close of the first half of 2012 upon us, we wanted to highlight some of those expected to report data or regulatory decisions before the end of June. Dynavax (NASDAQ: DVAX) is expected to report whether the FDA will designate priority review upon their Biologics License Application (BLA) for HEPLISAV. They are seeking […]
CELG – An analysis of Celgene’s CVR for Abraxane(CELGZ)
When Celgene (Nasdaq: CELG) acquired Abraxis back in June 2010 for around $2.9 billion, they tied contingent value rights(CVRs) to Abraxane, Abraxis’ lead drug. These CVRs trade under the ticker (Nasdaq: CELGZ). These CVRs have the potential to deliver some pretty substantial gains if any of the potential payments are delivered. There are roughly 43M […]
VRTX – Speculating on Vertex
In going through the database, I noticed that Vertex Pharmaceuticals (NASDAQ: VRTX) has a plethora of upcoming data that is worth mentioning. It’s data on literally the two hottest sectors: rare disease and hepatitis C(HCV). – Viral Kinetic Studies of Two Alios Nucleotides: Seven-day viral kinetic studies of the nucleotide analogues ALS-2200 and ALS-2158 are […]
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 […]
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 […]
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, […]
CLDX – Follow up on Celldex Therapeutics
It’s been a busy couple of weeks between traveling and ASCO 2012, so pardon the lateness of this report on the preliminary Phase 2 data that Celldex Therapeutics(NASDAQ: CLDX) presented on May 23rd. In our view, the data warrant further investigation of CDX-011 earlier in the disease and we look forward to the full results […]
BMRN – What’s going on at BioMarin
Biomarin(NASDAQ: BMRN) is a company that specializes in developing treatments for rare diseases. They currently have 4 approved drugs in Kuvan for PKU, Naglazyme for MPS VI Aldurazyme for MPS I, Firdapse(approved in the EU only) for LEMS. The majority of their current revenue comes from sales of Naglazyme with 2012 revenue guidance of $250 […]
ARQL – Post-ASCO take on Arqule
At ASCO 2012, Arqule (NASDAQ: ARQL) presented the full results from their randomized Phase 2 trial of Tivantinib in previously treated second-line treatment in hepatocellular carcinoma (HCC). In the ITT population, time-to-tumor progression was statistically significant with a hazard ratio [HR] = 0.64 (p-value = 0.04) with 6.9 weeks vs. 6.0 weeks. No real difference […]
ARRY – Post-ASCO take on Array Biopharma
Now that I have had some time to digest most of what I saw and heard at ASCO 2012, I wanted to share some of my thoughts on Array Biopharma (NASDAQ: ARRY). They had 2 key presentations: full data from their randomized Phase 2 of Selumetinib + Docetaxel(S+D) versus Docetaxel(D) in 2nd-line patients with KRAS […]
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 […]
ASCO 2012 presentations on my schedule
With the 2012 Annual Meeting of the American Society of Clinical Oncology(ASCO 2012) set to kickoff on Friday, June 1st (thru the 5th), I thought I would share my list of must-see presentations(the bolded ones with links). Abstracts for all others can be found here[link]. There are so many presentations but so little time, it […]
CLDX – Departing comments on Celldex
With Celldex Therapeutics (NASDAQ: CLDX) due to report results today at 4:30pm EST, we wanted to take a few moments to review a few additional points. For those unfamiliar with the Celldex story, see our recent article[link]. In my opinion, success in this and future trials depends on several variables: whether CDX-011 actually hits GPNMB […]
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 […]
