We wanted to take a moment to post some analysis on the upcoming FDA decision around Amarin (NASDAQ: AMRN). Amarin’s AMR101 was approved on July 27th under the tradename, VASCEPA. There has been a substantial amount of worry on whether VASCEPA will receive New Chemical Entity(NCE) status and the benefits it brings a new drug. […]
Bristol’s HepC Drug Fails – Now Idenix Compound Is On Clinical Hold
Bristol’s nuc, INX189, crashed not long after the compound was acquired through a $2.5 billion buyout of Inhibitex as a result of heart failure in one patient. Now the FDA has called for a partial clinical hold on a similar compound made by Idenix out of caution. IDIX stock has dropped about 30% today. Toxicity […]
SRPT – Sarepta Therapeutics Develops Promising Treatment For DMD
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 […]
SRPT – Sarepta Makes Strides In DMD
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 […]
HZNP – Horizon Pharma’s unsustainable business model
Horizon Pharma (NASDAQ: HZNP) currently has 2 FDA approved products, one of which is also approved in select EU countries. I view this company as significantly overvalued given their products have no data suggestion superiority claims over cheap generics. Products Duexis is a combination of ibuprofen 800 mg and famotidine 26.6 mg, indicated for rheumatoid […]
BMRN – Update on BioMarin’s BMN-673
As a follow up to our initial piece on BioMarin Pharmaceutical (NASDAQ: BMRN), we caught the 2Q quarterly conference call. We were particularly interested in what was said with respect to their oncology program, BMN-673, a PARP inhibitor. This program is currently being evaluated in 2 Phase 1 trials, one in hematological malignancies and another […]
Recent updates to our proprietary database
We wanted to walk you through the process of how we update our database and highlight a recent updates that we noticed. First off, we tend to update entries in the database about once a week, sometimes faster or slower depending on the number and importance of clinical/regulatory updates. (We get particularly hammered when the […]
CYTK – Cytokinetics Part 2: the skeletal muscle program
The main disease the program aims to treat is Amyotrophic Lateral Sclerosis (ALS). Despite being tested in other muscle wasting and debilitating diseases such as myasthenia gravis and claudication, we consider that the main value generator at present for the company’s skeletal program rests on the ALS indication. This is an unpartnered program that features […]
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 […]
ONCY – Phase III Trade Strategy
Some comments from Patrick on this name: When to expect the data: Oncolytics Biotech is running a two-stage Phase III clinical trial examining REOLYSIN® in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers (REO 018). From the company’s June 20th DMC safety review, “The study design stipulates that the study […]
GILD – Gilead’s battle plans for Hepatitis C
During their quarterly conference call on Jul. 26th, Gilead essentially showed their hand in HCV. With such swift plans in place and competitors much further behind, Gilead should have a commanding lead and marketshare for the foreseeable future in HCV. Their results presented at EASL12 in April have even been convincing some in the medical […]
INFI – A Summer of Transition at Infinity Pharma
So much for July and August being dead months in the biopharma sector. Infinity Pharma (NASDAQ: INFI) has released a string of updates that promise to completely alter the trajectory of the company compared to just a couple quarters ago. Entering 2012, Infinity’s lead program was the hedgehog inhibitor saridegib (IPI-926, background info here). Unfortunately the company […]
CRTX – Analysis on Cornerstone Therapeutics
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 […]
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 […]
