Synergy is a different kind of company- that is for certain. It is the epitome of a virtual biotech: it’s staff of nine is charged with running a pivotal 880 patient Phase II/III study; initiating follow-on projects; and in-licensing new compounds. The company’s lead candidate is plecanatide, a peptide analog of the human hormone uroguanylin. […]
September at the FDA
Upcoming regulatory decisions at the FDA in September should make for another FDA decisions expected on 4 New Drug Applications(NDAs) Salix Pharmaceuticals (NASDAQ: SLXP) – 9/5/12 Salix has a PDUFA date of Wednesday, September 5th, for Crofelemer 125 mg tablets. The indication sought is “for the control and symptomatic relief of diarrhea in patients with […]
ONCY – What’s going on at Oncolytics
Oncolytics Biotech (NASDAQ: ONCY) 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). We originally believed there was a chance to see data before August options expiration. This analysis provides further insight into why we believe this trial […]
HALO – Halozyme – The Platform Still Stands
Halozyme shares cratered following a Complete Response Letter (CRL) received by Pharma partner Baxter for the potential blockbuster drug HyQ on August 1. The FDA had concerns over high levels of non-neutralizing antibodies patients developed to recombinant human hyaluronidase, or rHuPH20, Halozyme’s platform technology. HyQ is a combination of PH20 with Baxter’s Gammagard (basically a […]
DEPO – Quick Update on Depomed
With Depomed’s recent PPS drop to below $5, many long-term investors have found themselves questioning their investment thesis. Although this past quarter has seen some interesting news releases, none have been able to move the stock price. Furthermore, the endless staring and tracking of weekly Gralise data has left investors, who lack patience, without a […]
AMRN – Issues surrounding the NCE status
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. […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]
CYTK – Cytokinetics Part 1: Omecamtiv mecarbil a promising drug that faces a tough road ahead.
This is the first of a two part series on Cytokinetics Inc (NASDAQ: CYTK). For the first article, we’ll discuss its cardiac program and in the second part, we’ll focus on the skeletal muscle program. Over the last few quarters, Cytokinetics has continued its downtrend amidst no relevant catalysts in the very short term, a […]
SNTA SPPI – Updates from JMP Securities Healthcare Conference
Next up in our dispatches from the JMP Securities Healthcare conference is a pair of oncology companies, Spectrum Pharma SPPI and Synta Pharma SNTA, that always seem to generate strong opinions among biotech investors. Spectrum Pharma $SPPI presentation by Shiv Kapoor, VP of Strategic Planning and Investor Relations This year we have already made […]
