The European Society for Medical Oncology (ESMO) Congress 2012 kicks off on September 28th thru October 2nd. Abstract titles are currently able to be viewed and searched here(link), but no other descriptive information is available. Abstracts will be available before-hand on September 17th, with late-breaking abstracts coming during the Congress. Synta Pharmaceuticals (NASDAQ: SNTA) Several sources […]
A glance at the upcoming European Respiratory Society meeting
This year’s meeting of the European Respiratory Society will be held in Vienna on September 1-5. There will be a good deal of presentations from some companies developing drugs in the respiratory space that we’ve covered in this article . British company Vectura (LSE: VEC) along with partner Novartis (NYSE: NVS), will be presenting further data […]
SGYP – Synergy Pharmaceuticals, Expecting Positive Data
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 […]
EXEL – In A Consolidation Mode
EXEL “Exelixis” had an impressive uptrend starting in June 2012, anticipating the FDA reply for the NDA filling & priority review, starting from the $4.40 area, reaching the $6.95 point on the day of the announcement that the FDA accepted its potential medullary thyroid cancer (MTC) treatment, cabozantinib, for priority review , which is shorter […]
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 […]
PPHM – More downside expected in Peregrine Pharmaceuticals
We have recently posted on Peregrine Pharmaceuticals (NASDAQ: PPHM) in the forums and decided to further elaborate on the company. There appears to be significant reasons to be cautious with this name. Upcoming catalysts for Peregrine over the next 12 months The following catalysts are expected, which are led by the median OS readouts from […]
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. […]
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 […]
