(Updated October 25th- MTC trial meets primary endpoint) Overview: Exelixis is a developmental stage oncology company with a single wholly owned compound XL184, or “cabozantinib” in Phase III trials for medullary thyroid carcinoma (MTC). This is a double blind placebo controlled trial with a final endpoint of progression free survival (PFS) initiated in 2008 after […]
INCY – Incyte: Q3 2011 Update
Incyte Corporation: October 27, 2011 Q3 Report Highlights: Incyte provided updates on its third quarter finances and key clinical programs this morning. The company is anticipating approval of ruxolitinib by the PDUFA date of December 3. Launch preparations are advancing; 60 reps have been hired. A request for modification of the Phase III RESPONSE trial […]
DEPO – Buying Opportunity after Serada failure
Earlier in October, Depomed (DEPO), announced results from it’s Phase 3 trial, called BREEZE 3, testing Serada, an extended release gabapentin formulation for the use in post menopausal hot flashes. The trial failed to meet 1 of 4 primary endpoints, and failed to meet its key secondary endpoints. Below is an excerpt from Depomed’s press […]
DEPO – Initiating Coverage on Depomed & Examining BREEZE-3
Initiating Coverage: Depomed is a commercial-stage specialty pharmaceutical company with three FDA approved products; ProQuin for infection, Glumetza for Adult Onset Diabetes Mellitus & Gralise for Post Herpetic Neuralgia. Within the next several weeks Depomed will launch Gralise in the USA with a detailing focus to high prescribing neurologists and pain specialists. Also, within the […]
INCY – Initiate Coverage on Incyte
Incyte Pharmaceuticals (INCY) Initiating Coverage: Incyte Pharmaceuticals is a small biotech company focused on developing treatments for cancer and inflammatory disorders. Lead compound Ruxolitinib (INCB18424) is awaiting FDA approval for the treatment of Myelofibrosis (MF) with an expected decision date on December 3rd. Ruxolitinib is also recruiting patients in a global Phase III study for […]
Keryx Rallies, But Remains Undervalued
Keryx Biopharmaceuticals is a developmental stage company with two drugs in the final stages of clinical development- quite an accomplishment for a company its size. With Zerenex, its drug for renal disease and Perifosine, its oncology drug, it appears to have good odds of passing FDA muster. Keryx is developing the phosphate binder, Zerenex, for […]
