With the summer almost over, we want to highlight some of the major medical meetings that will be pivotal events for many companies. September thru early December is ripe with upcoming data releases that can be presented at these events. We have attempted to list some of the more important conferences, but it’s entirely possible […]
Smallcap Phase 3 data expected by year-end 2012
This report will focus on some of the most anticipated Phase 3 trials that should read-out by the end of 2012. We’ve provided some thoughts on the potential for success of each program. This installment will focus on companies with market capitalizations below $1 billion. (Note, they are in alphabetical order, not most to least […]
SNMX – Senomyx shareholders need a bitter-blocker
Senomyx $SNMX is a company that uses biotechnology to develop novel flavor ingredients for the global food and beverage industry [see our initiation report for a detailed profile, and see the 2q-2012 news release for current status of each program]. We thought shares were attractively valued then, but SNMX has continued it’s steady downward slide ever since, […]
ESMO12 Abstracts of interest
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 […]
