YMI – YM Biosciences- A Quick Take

YM Biosciences- A Quick Take Tuesday, November 22 saw some wild moves in this stock, which plunged close to 38% in early afternoon trading before recovering for a 9.4% loss on the day. An astonishing 7.6 million shares changed hands, more than eight times the average for the previous three months. The action occurred on apparently no relevant news, […]

ONXX – Trade Idea

Onyx Pharmaceuticals(ONXX) submitted their NDA for Carfilzomib to the FDA under the accelerated approval process on 9/28/11 and are seeking a 6-month priority review. At the earliest, they could be hearing back from the FDA on Saturday, November 26th. Typically, the FDA will notify the sponsoring company within 60 days as to whether or not […]

PFE & BMY – The anticoagulant market & the Apixaban Catalyst

Background: The market for anti-thrombosis agents is set for dramatic changes.  A thrombus is an aggregation of platelets which plays a key part in several life-threatening diseases, such as myocardial infarction, stroke, deep-vein thrombosis, pulmonary embolism, stent thrombosis, as well as other medical conditions. The market for therapies against thrombosis can be broken down simply […]

Clinical database updates

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 […]

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 […]

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) […]