We got a chance over the past weekend to update the clinical database. After doing so, we felt the need to quickly highlight some potential catalysts. These events are likely to take place in the next 6 months and several companies have multiple upcoming value creating events. (To continue reading, sign up here or subscribers should […]
GILD – Gilead To Acquire Pharmasset For $11 Billion
Gilead To Acquire Pharmasset For $11 Billion Gilead has agreed to buy HCV drug developer Pharmasset Inc. for $11 billion in cash. The deal calls for payment of $137 per share, and represents an 89% premium to its Friday closing price. Gilead, a titan in the HIV space, has seen its shares stagnate in recent […]
INCY – Incyte’s Drug Receives FDA Approval- Update
Incyte Receives Approval For JAK Inhibitor In Myelofibrosis Following a trend begun earlier this year, the FDA skipped ODAC and approved another innovative cancer drug before its PDUFA date. Incyte’s JAK1, JAK2 inhibitor ruxolitinib, now dubbed Jakafi, received marketing authorization today, November 16, two and a half weeks ahead of the original December 3 decision […]
MNTA: Initiating Coverage
Overview Momenta Pharmaceuticals(NASDAQ:MNTA) is a biotechnology company that specializes in the development of complex generic and novel drugs. Momenta specializes in the detailed structural characterization and engineering of complex sugars and proteins. Momenta was the first company to receive approval for a generic Lovenox, which is low molecular weight heparin, required very precise characterization of […]
ARIA – Initiate Coverage on Ariad
ARIAD Pharmaceuticals: Initiate Coverage Overview Ariad is a clinical stage biotech company with three compounds in development, ranging from Phase I to NDA submission. The most important of these is ponatinib, a pan BCR-ABL inhibitor for the treatment of Chronic Myeloid Leukemia (CML) and potentially other cancers. The compound is in a global registration study […]
SNTS – Initiating Coverage on Santarus
On November 8th, Santarus (NADSAQ:SNTS) reported third quarter earnings of $0.01 per share, which was in-line with estimates. Interesting to note, SNTS management has guided higher on Glumetza sales, and has indicated that they are hiring 40 more sales reps to detail the drug. Management further indicated that they anticipate at least $25 million in […]
DEPO, XNPT, PFE – Managed-care to stunt Lyrica, Horizant and Gralise with step-edits
The Neurology and Pain sectors have been very interesting for biotech investors focused over the past year. Xenoport (NASDAQ:XNPT), Depomed (NASDAQ:DEPO), GlaxoSmithKline (NYSE:GSK) and Pfizer (NYSE:PFE) have all had regulatory successes over the past several months. The problem is the regulatory successes haven’t necessarily resulted in financial success for companies and their shareholders. At a […]
EXEL – Exelixis Update November 2, 2011- FDA Denies SPA
Exelixis Update November 2, 2011- FDA Denies SPA After hours on Halloween, Exelixis announced it could not reach an agreement with the FDA for the design of its pivotal ‘306 trial of cabozantinib in metastatic castrate resistant prostate cancer (mCRPC) four months after its initial application. That said, the company has decided to initiate the […]
EXEL – Exelixis Update And Catalyst Report
Exelixis Update and Catalyst Report Overview: Lots going on at Exelixis end of this year. The company gave an overview of top-line data from recently announced successful EXAM medullary thyroid cancer (MTC) trial. As previously mentioned, patients on XL184 (cabozantinib) had progression free survival (PFS) of 11.2 months compared to 4.0 months for placebo. The […]
PCYC – Pharmacyclics: Initiate Coverage
Overview: Pharmacyclics is a mid-stage drug discovery company with several compounds in clinical development. The company’s major focus is a Bruton’s Tyrosine Kinase (Btk) inhibitor for non-Hodgkin’s Lymphoma (NHL) and Multiple Myeloma, PCI-32765, now in Phase II trials. It is in a broad program in testing against the major NHL subtypes both as monotherapy and […]
EXEL – Initiating Coverage on Exelixis
(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 […]
