Archive for March, 2013
A.P. Pharma Receives Complete Response Letter on APF530 (APPA.OB, $0.34)
Overview A.P. Pharma has just released the disappointing news that it has received a Complete Response Letter for APF530. The press release described three issues that led to the CRL. · With respect to chemistry, manufacturing and controls (CMC), the FDA has requested the refinement of one product quality analytical test method, and that certain […]
ImmunoCellular Therapeutics: A Close Look at Key Issues for the Ongoing Phase II Trial of ICT-107 (IMUC, $2.69)
Investment Thesis It is my hypothesis that dendritic cell cancer vaccines have the promise to be a major advance in cancer therapy. In October of 2011, Dr. Ralph Steinman was posthumously 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 […]
Cytokinetics: Critical Phase IIB Data is Upcoming in 2013 for Omecamtiv Mecarbil and Tirasemtiv (CYTK, Buy. $6.30)
Key Investment Considerations Cytokinetics Has Two Key Drugs in Phase IIb Development Cytokinetics (CYTK) has been the pioneer in developing new drugs based on muscle biology which modulate the mechanics of muscle, particularly those which affect contractility. It has two late stage drugs that will be reading out data on critical phase IIb trials […]
Discovery Laboratories: The Surfaxin Launch and Beyond (DSCO, $2.38)
Investment Thesis We are now nearing the long awaited launch of Surfaxin. During the recent conference call on results for 4Q, 2012, the Company reaffirmed that it is anticipating the launch of Surfaxin in 2Q, 2013. The company through a debt deal with Deerfield Capital recently brought in $10 million of cash and will receive […]
InSite Vision: Positive Phase III Trial Results for BromSite Reduces Much of Downside Risk in the Stock (INSV.OB, $0.30)
BromSite Results are Strikingly Positive in First Phase III Trial InSite Vision (INSV.OB) just announced top-line results from its first phase III trial of BromSite which is indicated for the reduction of inflammation and pain after cataract surgery. BromSite is the anti-inflammatory drug bromfenac delivered with the Company’s proprietary DuraSite drug delivery system; it was […]
NovaBay: Topline Data from Two Phase IIb Trials Presents an Asymmetric Investment Opportunity in 2013 (NBY, $1.24)
Introduction NovaBay (NBY) is focused on the development of novel anti-microbial products that are topically applied as gels, liquid solutions and instillates. By replicating the mechanism of action used by the body’s innate immune system, NovaBay has created products that hold the potential to treat bacteria and microbes resistant to currently used drugs and as […]
Trius: Topline Data of Second Phase III Trial of Tedizolid is Eminent (TSRX, $6.76)
Investment Summary and Conclusion I began recommending Trius (TSRX) with an initiation of coverage report that was published in May of 2012 and I continue to recommend the stock. That report and three subsequent updates explain my thinking on the clinical and commercial potential of its lead drug tedizolid, an antibiotic that is effective against […]
Cadence: Potential Near Term Catalyst for the Stock (CADX, $5.34)
Investment Thesis I continue with my buy recommendation on Cadence Pharmaceuticals (CADX). I believe that there is a high probability for an important near term catalyst that could give the stock a nice boost. This would be a legal settlement with Exela Pharmaceuticals, which is challenging Ofirmev’s patents. If it is similar to a settlement […]