Duchenne’s Muscular Dystrophy (DMD) is a genetic disorder that afflicts approximately 1 out of every 3,600 male infants. The inherited disease is caused by mutations in the gene for dystrophin- a muscle protein- resulting in muscle weakness at an early age that quickly worsens over time. Breathing difficulties and heart disease typically begin in the […]
INCY – Q2 Earnings Call
For the first time since the launch of recently approved myelofibrosis drug Jakafi, Incyte provided revenue guidance for the year – and investors were disappointed. Overview: While Q2 product sales were slightly above expectations at $32.7 million, projected 2012 revenue of between $120 and $135 million were below some analyst estimates of as high as […]
ECYT – Holds Promise
Endocyte was looking good during ASCO 2011 when it released results from its Phase II PRECEDENT study of women with platinum-resistant ovarian cancer (PROC). Data presented showed the company’s lead compound, EC145, in combination with pegylated liposomal doxorubicin (PLD) improved median progression free survival (PFS) over PLD alone. A pivotal Phase III trial was initiated […]
FOLD – Quick Take – Amigal P3 Monotherapy
Amicus Therapeutics is expected to unveil results from its Phase III registration trial for migalastat (Amigal) as monotherapy for the treatment of Fabry disease in the third quarter of this year. The study, if successful, will allow Amicus to file for marketing approval in the U.S. A separate global Phase III is also in progress. […]
YMI – A Billion Dollar Company?
Shares of YMI are trading at about $1.96, valuing the company at $309 million; adding in 7.4 million warrants along with 8.2 million options gives a fully diluted value of $339 million. YM Biosciences has several assets: JAK inhibitor CYT387, anti-EGFR antibody Nimotuzumab, and CYT997, a so-called vascular disrupting agent. Investors are focused largely on […]
INCY – An Immunotherapy Play?
At ASCO this past June, Incyte presented early data from its new Indoleamine 2,3-dioxygenase-1 (IDO-1) inhibitor project. Their small molecule inhibitor, INCB024360, was tested primarily to determine safety and tolerability; secondary endpoints included PK, biomarkers, and signs of anti-tumor activity. The compound demonstrated a good safety profile among 38 patients, with the maximum tolerated dose […]
INFI – Pivoting From Hedgehog to PI3K
Failed trials can’t hold this stock down. In recent months, the hedgehog pathway inhibitor saridegib (also known as IPI-926) – once the company’s leading pipeline candidate – has crashed out of pancreatic cancer, chondrosarcoma and myelofibrosis trials, but the stock has since broken out to new 52-week highs. Following these disappointments, Infinity has discontinued all […]
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 […]
A Deliberate Walk Down Wall Street – Opinion
The Random Walk Hypothesis first emerged in the 1800s and was popularized in 1973 by Burton Malkiel in his book titled, “A Random Walk Down Wall Street”. This theory asserts that stock prices move randomly and can not be predicted by market participants; any observed cycles are purely due to chance. It is closely linked […]
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 […]
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 […]
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 […]
IDIX – The Patent Interference Case
In early March, Idenix announced the USPTO (US Patent and Trademark Office) had declared a patent interference between its U.S. Patent Application no. 12/131,868 and Pharmasset’s (now Gilead’s) U.S. Patent no. 7,429,572. Idenix, with the earlier filing date, has been designated the senior party in this dispute, where the principal issue is to determine priority […]
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) […]
INCY – An Acquisition Target?
Today, any biotech company with a promising product may be considered a potential acquisition target. Incyte Pharmaceuticals can certainly be considered one such candidate. It is well known that Big Pharma has been struggling with a lack of productivity, exacerbated by expiring patents on their biggest drugs. Some companies have managed this better than others. […]
VRTX – Vertex Sweat Chloride to FEV1 Correlation in Cystic Fibrosis
Vertex released interim data May 7th of an ongoing combination study of VX-809 and KALYDECO in Cystic Fibrosis patients with two copies of the F508del mutation. Results were very good- VX809 plus Kalydeco led to significant improvements in lung function (as measured by absolute change in percent predicted FEV1). Treatment Group Absolute Improvement from Baseline in Lung Function (FEV1) […]
IDIX – To Market By 2015?
Idenix presented at the 37th Deutsche Bank Annual Health Care Conference May 7th. Yeah, not the most exciting event, but still worth mentioning. CEO Ron Renault gave a run-down of the company’s highlights, mostly rehashed from previous presentations, but there were some interesting tidbits. It will be key to be on the market by the […]
INCY – Summary Q1 2012 Report
Incyte Pharmaceuticals had a very good quarter- the company recorded $25.1 million of total product shipped to distributors, and $19.3 million in net sales. This compares to $2 million in net sales during the last few weeks of Q4 following Jakafi’s FDA approval on November 16 2011. Shares have jumped about 16% the last couple […]
POZN – FDA Asks For More Data
During a pre-submission meeting for the filing of PA32540, the FDA asked Pozen to seek approval for a lower aspirin dosage formulation of 81mg along with their current 325mg. The FDA indicated that without a lower dosage form, it may restrict PA32540’s indication to use in use in post coronary artery bypass graft surgery (CABG) […]
