Archive for April, 2012
Antares: Settlement of Litigation on EpiPen is a Positive (AIS, $3.08)
Conclusion I believe that the settlement on the EpiPen litigation is a positive for Antares. It pushes the launch date for the generic epinephrine injector from 2013 to 2015. However, during this time, EpiPen sales are expected to grow rapidly increasing from $600 million in 2012 to $1.3 billion in 2015. Based on calculations shown […]
Initiating Coverage of A.P. Pharma with a Buy (APPA, $0.42)
I have just published a report initiating coverage on A.P. Pharma (APPA, $0.42) in which I recommend purchase; my 2015 price target is $5.00+. The recommendation is keyed to the projected approval of APF530 for the treatment of chemotherapy induced nausea and vomiting in early 2013 and launch in the US in mid-2013. Most newly […]
Highlighting A New Report on Dendritic Cell Cancer Vaccines
Northwest Biotherapeutics’ (NWBO) DCVax-L and ImmunoCellular Therapeutics’ ICT-107 are dendritic cell cancer vaccines that are in phase II trials for the treatment of glioblastoma multiforme, the most malignant form of brain cancer. Their dendritic cell technology is the same as that used by Dendreon’s Provenge. Importantly, NWBO and IMUC both have much more efficient manufacturing […]
The Rationale Behind Dendritic Cell-Based Cancer Vaccines and How They are Manufactured (NWBO.OB, $0.22)
Dendritic Cell-Based Cancer Vaccines Could Be a Major Advance In October of 2011, Dr. Ralph Steinman was post-humously awarded one-half of the Nobel Prize in Physiology or Medicine for his discoveries of the dendritic cell and its role in adaptive immunity. His discoveries have made possible the development of therapeutic cancer vaccines that are produced […]
Savient: Recommending A Switch Into Discovery Laboraratories (SVNT, $2.31)
I have decided to go the sidelines on Savient (current price of $2.31) and I am recommending a switch into Discovery Laboratories (current price of $3.05). The critical issue with Savient is when a significant inflection point for Krystexxa sales might occur. It appears that based on audit data that sales are growing quarter over […]
A.P. Pharma: Initiating Coverage with a Buy (APPA.OB, $0.42)
Key Investment Conclusions In this report, I have made projections for sales, earnings and cash flow for A.P. Pharma (APPA.OB) through 2016. The underlying assumptions and calculations are explained within this report. However, let’s start with the conclusions. My base investment case is that A.P. Pharma will gain approval for its first commercial product APF530 in […]
The Launch of Transcept’s Intermezzo by Purdue Has Begun (TSPT, $10.92)
Investment Opinion and Overview Now is the moment of truth for Transcept (TSPT) as the launch of Intermezzo has begun. I recommended Transcept in a report published on January 24, 2012 and I continue to recommend the stock. I would suggest that investors who need a refresher or are not familiar with the Transcept story […]
Levadex Receives Complete Response Letter, What Does This Mean for the Stock? (MAPP, $16.44)
Summary I think that it is a question of when and not if Levadex is approved. The complete response letter or CRL issued for Levadex appears to be resolvable fairly quickly and could result in approval in July to October of 2012 in my best case scenario. In the worst case, I estimate that approval […]
Levadex Has a Good Chance for Approval on its March 26th PDUFA Date (MAPP, $17.09)
Investment Opinion, In Brief The PDUFA date for Levadex, MAP Pharmaceutical’s lead product, is looming on March 26, 2012. I believe that there is a very high probability for approval and only a small chance for a Complete Response Letter. A CRL, if issued, would likely relate to the Chemical, Manufacturing and Control (CMC) section […]
There are Good Reasons to Remain Positive on Dendreon (DNDN, $11.14)
When I was in high school I played the trombone in the marching band. I could never stay in step, but my mother always encouraged me when she said that everyone was out of step except me. I feel the same way now as I am positive on the outlook for Dendreon (DNDN) at a […]