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 […]
AMRN – Put Sale
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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 $137 per share, and represents an 89% premium to its Friday closing price. Gilead, a titan in the HIV space, has seen its shares stagnate in recent […]
BPAX – Trade Ideas for LibiGel Phase III Data
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INCY – Incyte’s Drug Receives FDA Approval- Update
Incyte Receives Approval For JAK Inhibitor In Myelofibrosis Following a trend begun earlier this year, the FDA skipped ODAC and approved another innovative cancer drug before its PDUFA date. Incyte’s JAK1, JAK2 inhibitor ruxolitinib, now dubbed Jakafi, received marketing authorization today, November 16, two and a half weeks ahead of the original December 3 decision […]
INCY – Incyte’s Jakafi post-approval conference call – Live Blog
INCY post-approval conference call
TSPT – Put Ratio (Part 2)
Video: http://content.screencast.com/users/biotechtraderHB/folders/Default/media/2acf5e03-4146-4f98-b857-f005296c5ffc/$TSPT111411a.swf&blurover=false
TSPT – Neutral Trade Idea (Part 1)
Video: http://content.screencast.com/users/biotechtraderHB/folders/Default/media/aec06074-e5c3-4827-8aeb-1d9a9b38b1b9/$TSPT111411.swf
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 […]
ALIM & PSDV – Trade Review
We fully expected that pSivida(NASDAQ: PSDV) and Alimera Sciences(NASDAQ:ALIM) will receive another Complete Response Letter for ILUVIEN in the treatment of diabetic macular edema (DME). We see little reason for the FDA to approve this NDA, based on the safety and efficacy data. Both PSDV and ALIM will be hard up for cash if ILUVIEN […]
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 $25 million in […]
INHX – Trade Idea
Video: http://content.screencast.com/users/biotechtraderHB/folders/Default/media/e7f5888c-ae53-412d-ad9e-36eee29a425b/$INHX110911.swf Analyst Notes: INHX showed only 7 day viral reduction data, which has not been shown to be highly correlated to a sustained viral response. What we want to see are 4 week results demonstrating high rates of rapid virologic response, or undetectable levels of viral rna. 4 week data is highly predictive of […]
INCY – PDUFA Trade Note
Incyte Pharmaceuticals is awaiting FDA approval of its lead compound Ruxolitinib (INCB18424) for the treatment of Myelofibrosis (MF) with an expected decision date on December 3, 2011. Our analysis suggests a high probability of approval (please see our recent Research Report). We expect the shares to trade over $15 a share. Analyst estimates currently place […]
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 […]
Trade Strategy: Approaching Catalysts
Its end of year 2011 and there are a large quantity of trading opportunities approaching. On the docket: $ALIM – PDUFA (NOV 12, 2011) $SPPI – PDUFA (NOV 20, 2011) $TSPT – PDUFA (NOV 27, 2011) $INCY – PDUFA (DEC 3, 2011) $AFFY – Advisory Committee (DEC 2, 2011 / PDUFA on MAR 27, 2012) […]
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 […]
