Post archive for ‘Company Reports’
InSite Vision: Upcoming Topline Results from Clinical Trials Presents a Buying Opportunity (INSV.OB, $0.34)
Investment Overview and Opinion In the first half of 2013, InSite Vision (INSV.OB) will release significant topline data from two phase III trials involving three new products: BromSite, AzaSite Plus and DexaSite. Topline data for the first of two phase III trials of BromSite to treat pain and inflammations following cataract surgery likely will be […]
Discovery Laboratories: Disappointment with the Delay in the Surfaxin Launch Has Created a Buying Opportunity (DSCO, $2.24)
Introduction I had the opportunity to meet with the management of Discovery Laboratories (DSCO) recently and focused on several issues: The problem with one of a number of tests used in quality assurance that was announced in October, 2012 and has delayed introduction from the planned launch of Surfaxin from November, 2012 to 2Q, 2013. […]
OncoSec Medical Initiation of Coverage
Introduction OncoSec Medical is an emerging immunotherapy and drug delivery company with unique and interesting products and encouraging clinical data. Those who follow my work know that I have a special interest in active immunotherapy. I see OncoSec as having a promising and differentiated approach to immunotherapy with its lead product ImmunoPulse. At present, only […]
Repligen: Initiating Coverage with a Buy (RGEN, Buy, $6.13)
Investment Opinion Repligen (RGEN) has gone through a metamorphosis that has dramatically changed its business model and investment outlook. For years, it was focused on drug development but it was also building a high quality bioprocessing business that provides consumable products used in the manufacturing of biological products. The acquisition of a major competitor, Novozymes […]
NovaBay Swings for the Fences with NVC-422 Trial In Viral Conjunctivitis
Investment Thesis Although NovaBay is a small company as judged by its $43 million market capitalization, it is complex to analyze. It is developing one molecule, NVC-422, for three separate indications, impetigo, viral conjunctivitis and urinary encrustation and blockage. While the molecule is the same, the disease states are quite different as is the formulation: […]
Initiating Coverage of Neuralstem with a Buy (CUR, $0.92)
Product Development Overview This report provides an introduction to stem cells and the cells that comprise the central nervous system. Basic knowledge of both is needed to understand the investment thesis for Neuralstem. Its technology platform is based on first isolating neural stem cells from fetal tissue and then expanding them in cell cultures to […]
Focusing on the Impetigo Indication for NVC-422 (NBY, $1.29)
Investment Thesis Although NovaBay(NBY) is a small company as judged by its $37 million market capitalization, it is complex to analyze. It is developing one molecule, NVC-422, for three separate indications, impetigo, viral conjunctivitis and urinary catheter encrustation and blockage. While the molecule is the same, the disease states are quite different as is the […]
NovaBay’s Robust Clinical Pipeline Approaches Critical Clinical Trial Results in 2013
Investment Thesis NovaBay has just received approval in the US for its first product NeutroPhase and will be commercializing it throughout the world using regional partnerships. It has a much more important second product, NVC-422, which is being developed for three distinct disease indications: as a dermal gel for the skin disease impetigo, an eye […]
Settlement Between Pfizer and Teva on Generic Zyvox is a Significant Positive for Trius Therapeutics
The Issue On May 31, 2012, Pfizer Inc. (PFE) and Teva (TEVA reached a settlement that licenses to Teva a generic version of Pfizer’s antibiotic Zyvox (linezolid). Pfizer first sued Teva in January 2010 for patent infringement after Teva informed Pfizer that it had filed an abbreviated new drug application with the FDA.This was done […]
Northwest Biotherapeutics and ImmunoCellular Therapeutics Can Both Be Winners with their Cancer Vaccines (NWBOD, $5.50)
Investment Perspective I think that some investors are incorrectly viewing the investment outlook for Northwest Biotherapeutics and ImmunoCellular Technologies (IMUC.OB). Both companies are developing dendritic cell vaccines for glioblastoma multiforme, the deadliest form of primary brain cancer; NWBOD’s product is called DCVax-L and IMUC’s is ICT-107. Some investors have portrayed this as a winner take […]