Post archive for ‘Company Reports’
Budesonide MMX’s Potential in Ulcerative Colitis (SNTS, $3.18)
Investment Thesis This report focuses on the ulcerative colitis market and particularly on budesonide MMX, an important new drug being developed by Santarus for this disease. It uses a novel drug delivery technology in combination with the now generic, non-systemic corticosteroid budesonide. Santarus currently markets three drugs. Its first marketed drug Zegerid has been impacted […]
FDA Advisory Committee Recommendation for Approval of Xarelto Bodes Well for Approval of Eliquis (apixaban)
The FDA had apparently slammed the door shut on approval of Johnson & Johnson’s Xarelto (rivaroxaban) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF). The FDA reviewer in his briefing papers to the committee had recommended that the product be given a Complete Response Letter (not approvable at this time). The reviewer did […]
FDA Advisory Committee Goes Against FDA and Recommends Approval of Xarelto
The FDA had apparently slammed the door shut on approval of Johnson & Johnson’s Xarelto (rivaroxaban) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF). The FDA reviewer in his briefing papers to the committee had recommended that the product be given a Complete Response Letter (not approvable at this time). The reviewer did […]
Rhucin in the Hereditary Angioedema Market Can Be A Meaningful New Product for Santarus (SNTS, $3.14)
Investment Thesis This report is intended to highlight the potential for four current products and one in development for the treatment of hereditary angioedema (HAE), a rapidly growing market. The HAE market is in an early and dynamic period of growth that should last for the next several years. I project that the US market […]
Kalbitor Prospects Are Not Good in Hereditary Angioedma (DYAX, $1.61)
Investment Thesis This report is intended to highlight the potential for four current products and one in development for the treatment of hereditary angioedema (HAE), a rapidly growing market. The HAE market is in an early and dynamic period of growth that should last for the next several years. I project that the US market […]
Firazyr Has Excellent Potential in the Hereditary Angioedema Market (SHPGY, $96.48)
Investment Thesis This report is intended to highlight the potential for four current products and one in development for the treatment of hereditary angioedema (HAE), a rapidly growing market. The HAE market is in an early and dynamic period of growth that should last for the next several years. I project that the US market […]
ViroPharma’s Cinryze is Well Positioned for Growth in the Hereditary Angioedema Market (VPHM, $18.99)
Investment Thesis This report is intended to highlight the potential for four current products and one in development for the treatment of hereditary angioedema (HAE), a rapidly growing market. The HAE market is in an early and dynamic period of growth that should last for the next several years. I project that the US market […]
Xarelto’s Problems are Eliquis’ Opportunities (BMY. $29.90)
Investment Opinion I have been on the fence in deciding whether to upgrade Bristol-Myers (BMY) to a Buy. The issues now facing rivaroxaban are all significantly to the benefit of BMY’s apixaban and cause me to go to a Buy on Bristol-Myers Squibb. The FDA problems encountered with rivaroxaban are a significant, but not crushing […]
How Effective is Provenge (DNDN, $12.15)
A criticism that is heard over and over from lay people is that Provenge provides only marginal benefit with an increase of 4.5 months median overall survival. This view is in direct opposition to the views of the FDA and expert oncology community on the importance of improvements of this magnitude in mean overall survival. […]
Initiation of Coverage of ImmunoCellular Therapeutics (IMUC.OB)
Investment Overview ImmunoCellular Therapeutics (IMUC.OB) lead product ICT-107 is a dendritic cell vaccine for treating glioblastoma multiforme (GBM). Its technology is a next generation version of that used by Dendreon to develop Provenge for prostate cancer. GBM is a relatively rare, but deadly primary tumor of the brain. While it only affects about 11,000 Americans […]