Arena Pharmaceuticals (ARNA) Rough Share Price Target if Approved
I have gotten a lot of questions about a target price for Arena or the market share for their drug Lorcaserin if it gets approved. I’ll be honest, I haven’t done a lot of due diligence into the pricing that Arena was looking to put on the drug, but previously I had done an analysis on Vivus for what kind of revenues that company might be expecting. » Read more: Arena Pharmaceuticals (ARNA) Rough Share Price Target if Approved
Jazz Pharmaceuticals (JAZZ) JZP-6 Part I
This is part I of an analysis I’ll be doing on Jazz Pharmaceuticals drug JZP-6. Part I is geared towards newbies in pharma investing and covers the basic dates before the advisory panel.
So anytime there is an Advisory hearing I like to post a timeline of events that will occur before the panel meeting. On August 20, 2010, the FDA will meet with Jazz Pharmaceuticals to discuss their fibromyalgia drug JZP-6, » Read more: Jazz Pharmaceuticals (JAZZ) JZP-6 Part I
Geron Corporation (GERN): The Story of the Day
Geron received really positive news this morning. The company said that the FDA has notified the company that the clinical trial hold that was placed on their Stem Cell Phase I clinical trials is now allowed to proceed. » Read more: Geron Corporation (GERN): The Story of the Day
Dr. Pazdur Speaks out on Cancer Trials and Accelerated Approvals
So a lot of investors have been wondering what will happen to cancer drugs that are in the Accelerated approval process because of the recent fiasco surrounding Avastin. For those that don’t know the story, Avastin is a drug for breast cancer that has had significant setbacks. The drug was approved under the FDA’s coveted Accelerated Approval Process. » Read more: Dr. Pazdur Speaks out on Cancer Trials and Accelerated Approvals
Intermune (ITMN) Conference Call Rundown
So during the Intermune conference call there were several questions regarding the company’s Roche partnership on Danoprevir, but I think what investors really wanted to hear was more information on Pirfenidone. So let me cover the more important parts of the call in relation to the drug. » Read more: Intermune Update on Pirfenidone
Jazz Pharmaceuticals’ (JAZZ) FDA Warning Letter and its Implications
I have to admit, I only briefly reported on this when it happened about a month ago, but I was surprised to find out when I spoke with a couple of investors who were long time followers of the company that they hadn’t heard about it. » Read more: Jazz Pharmaceuticals’ (JAZZ) FDA Warning Letter and its Implications
Generex (GNBT):
Generex said this morning that they had now achieved 75% of the required number of per-protocol completers in its Phase III trial of Oral-lyn. The company noted that early results may suggest that the use of Oral-lyn will support a non-inferiority claim relative to standard of care injectable insulin. The company reiterated that patients taking Oral-lyn on average showed no weight gain and an actual decrease in Body Mass Index (BMI). » Read more: Daily Pharma Watch
So I have gotten a lot of questions about whether or not I think Cell Therapeutics will effect a reverse stock split or if they will need to raise capital. So per my last post back at the beginning of July I briefly went through their financing situation. Here it is: » Read more: Cell Therapeutics (CTIC) : Financing Options Ahead
Questions for the Intermune (ITMN) Conference Call
So after the rebuff earlier this year from the FDA for Intermune’s lead product pirfenidone, the company will hold a conference call to discuss its quarterly progress. Since there has not been much clarity on how the company plans to come forward I expect there to be several questions on the topic of moving the pirfenidone development program forward. » Read more: Questions for the Intermune (ITMN) Conference Call
Antigenics Inc. (AGEN):
This morning Antigenics announced positive results from their Phase I clinical trial in herpes patients. The company was testing their developmental vaccine AG-707 on 35 herepes positive patients. The company noted that the patients who received the vaccine showed a statistically significant CD4+ T Cell response and a majority also showed a CD8+T Cell response. CD4+ cells are also known as helper cells because assist other white blood cells in the immunologic processes, while CD8+ cells are known as Cytotoxic cells because they destroy virally infected cells and tumor cells. » Read more: Daily Pharma Watch
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