Antares Pharma $ATRS (formerly $AIS) developed Anturol, a proprietary drug-device combination for overactive bladder (OAB) consisting of a metered-dose pump that dispenses a gel containing the active ingredient oxybutynin. The product was licensed to Watson Pharma $WPI in July 2011, received FDA approval in December 2011, and launched in April 2012 with the brand name […]
ARNA – Quick Update on Arena’s upcoming PDUFA date
Arena’s June 27th PDUFA date is quickly approaching. After the FDA Advisory Committee voted strongly in favor of approving Lorcaserin, for the treatment of obesity, mostly all pundits and analyst have all but claimed victory for Arena’s upcoming PDUFA date. We feel that despite modest efficacy, Lorcaserin has a high degree of likelihood for approval. […]
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 […]
ALNY TKMR – Updates on Alnylam and Tekmira
This post will provide a few updates from a number of recent presentations by Alnylam $ALNY (First Quarter 2012 earnings call and conference call regarding ALN-RSV data) and Tekmira $TKMR (First Quarter 2012 earnings), two developers of RNAi technology and therapeutics that are simultaneously partners and bitter opponents in a series of legal battles. My […]
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 […]
CBST – An Outlook
Cubist management gave a five-year outlook at their Investor Day presentation on June 11; it was quite impressive. The most notable point was management’s projection of $2 billion in global revenue by the end of 2017- more than double expected 2012 sales. Moreover, Cubist aims to increase non-GAAP operating income to $700 million. Achieving the […]
IDIX – Quick Take on IDX184
Idenix released SVR4 data for its lead drug IDX184 and early 3-day results of the promising NS5A inhibitor IDX719 Tuesday afternoon. Both sets of data looked good, sending IDIX shares soaring in after-hours trading. 31 patients from the first cohort of Idenix’s Phase IIb study were randomized to either 50mg (n=16) or 100mg (n=15) IDX184 […]
INFI – Update on Infinity Pharmaceuticals
For the second time this year, on June 18th, 2012 Infinity Pharma held a conference call to discuss their hedgehog pathway inhibitor drug candidate saridegib (IPI-926). Unfortunately, as in January, the news was not good. After the data monitoring committee stopped the saridegib plus gemcitabine trial in January, Infinity decided to proceed with additional trials in […]
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 […]
Updates from the Jefferies Global Healthcare Conference
The 2012 Jefferies Global Healthcare Conference was held June 4-7, 2012. You can access the full schedule and webcasts here. I’ll provide brief updates on the presentations by several companies in this post. Keep your eye on the Chimera Proprietary Calendar for all upcoming investor meetings, with links to the webcasts and schedules. Note that […]
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 […]
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 […]
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 […]
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 […]
EASL – A Look Back- Lessons Learned
There were some early winners and losers this year at EASL. Here we examine a few new interferon-free combination treatments, the most exciting development in HCV today; and look outward to determine how the future may shape up. The Good News: The star of the stage, once again, was GS-7977 (formerly PSI-7977). Gilead’s nucleotide polymerase […]
