Vivus (VVUS), is a specialty pharmaceutical company with two lead product candidates that are facing a regulatory decision within the next 6 months. Besides two PDUFA dates, VVUS also has an FDA Advisory Committee Meeting and results from a key study, dubbed FORTRESS, due out in the coming days. The most anticipated drug candidate […]
AVEO – Initiating Coverage
Overview AVEO Pharmaceuticals(NASDAQ: AVEO) is a clinical stage cancer therapeutics company with 2 main compounds in development. AVEO’s lead candidate, Tivozanib(AV-951), is designed to block the VEGF pathway by inhibiting all three VEGF receptors(1,2,3). Tivozanib is currently being tested in a pivotal Phase 3 clinical trial called TIVO-1, which is comparing Tivozanib to Onyx’s sorafenib […]
YMI – ASH 2011 Update
YM Bioscience stock surged in after hours trading following their presentation of results from an ongoing multi-center Phase I/II study of the JAK1/2 inhibitor CYT387 for the treatment of Myelofibrosis (MF) at ASH Monday afternoon. Shares jumped to as high as $2.04 in after-hours trading before settling to $1.69 Tuesday. It has since fallen to […]
BPAX – Picking up the pieces
After much anticipation, BioSante Pharma $BPAX released top-line data for the two pivotal phase 3 efficacy data for LibiGel, a testosterone gel for the treatment of hypoactive sexual desire disorder (HSDD) on December 14, 2011. Quite simply, the results were disastrous. LibiGel failed to show a significant improvement in the number of satisfying sexual events (SSEs) or sexual […]
INCY – ASH Update: Incyte’s JAK1/2 Inhibitor
ASH Update: Incyte’s JAK1/2 Inhibitor By Patrick Crutcher and Jason Chew On Saturday December 10, we took to the floors of the San Diego Convention Center for the opening rounds of ASH presentations. Today’s focus was mainly on the poster sessions with presenters manning their stations beginning at 5pm. The item we were most interested […]
SPPI – Generic Fusilev fears cause sell-off
Spectrum Pharma $SPPI shares were lower by as much as 10% on Friday 12/9/2011 based on concerns over potential generic competition for their cancer drug Fusilev (levoleucovorin). A flurry of media interviews by management and a press release defending Fusilev’s patent protection helped the stock recover part of its losses by the market close. Fusilev, […]
PCYC – Update- Pharmacyclics Signs Worldwide Development Deal With Janssen Biotech
PCYC: Update- Pharmacyclics Signs Worldwide Development Deal With Janssen Biotech On December 8, 2011, Pharmacyclics announced it had entered into an agreement to jointly develop its lead BTK inhibitor PCI-32765 with Janssen Biotech, a division of Johnson & Johnson. The deal calls for upfront payments of $150 million and up to an additional $825 million […]
ACHN – Initiating Coverage
Achillion: Initiating Coverage Background: Achillion is a small biotech focused on the development of a cure for Hepatitis C. It has several compounds in its pipeline, all unpartnered. The two leading products are next-generation protease inhibitors, ACH-1625 and ACH-2684, followed up by a duo of NS5A inhibitors, ACH-2928 and ACH-3102. There has been considerable M&A […]
ARQL – Initiating Coverage
ArQule Inc.(NASDAQ: ARQL) is a mid-stage small molecule drug company that specializes in the development of tyrosine kinase inhibitors(TKIs). Their in-house drug development program, ArQule Kinase Inhibitor Platform (AKIP™), produced their lead product candidate, ARQ197, a selective small molecule inhibitor of the c-MET receptor tyrosine kinase. With Tivantinib entering Phase 3 trials in non-small cell […]
GILD – Does Pharmasset Acquisition Make Gilead A Growth Company Again?
Does Acquisition Of Pharmasset Make Gilead A Growth Stock Again? Gilead stock has been stagnant for years as growth in its core HIV franchise has slowed. Acquisitions out designed to diversify the company’s pipeline have met with only modest success. Attempts to move quickly into cardiovascular and pulmonary diseases have been disappointing. More recently, Gilead […]
VRUS – Pharmasset Stock Falling- How To Play It
Pharmasset Stock Falling- How to Play It Pharmasset (VRUS) stock has fallen steadily since November 21st when the company announced it had decided to sell itself to Gilead (GILD) for $137 per share in cash. After hitting a high of $135, the stock has subsequently drifted down to $128.89. This leaves a substantial 6% arbitrage […]
Clinical data expected by end of 2011
This post is meant to highlight some of the key data that is expected by year’s end 2011. We have highlighted some of those catalysts which should have a significant impact on price. We have some forthcoming coverage on ONXX, CELG, and ACHN. Data expected at the annual meeting of the American Society of Hematologists, […]
INCY – Stock Running Ahead Of ASH
Incyte Corp: Stock Running Ahead Of ASH Despite today’s slight pull-back, Incyte stock is finally making a comeback. It appears the company’s discussions at the November 29th Piper Jaffray Healthcare Conference have given investors renewed confidence that newly approved Jakafi will indeed have significant sales potential. Patricia S. Andrews, head of commercial operations did most […]
Regulatory catalysts expected by end of 2011
This post is meant to highlight some of the key regulatory decisions that are expected by year’s end 2011. We have highlighted some of those catalysts which should have a significant impact on price. We should have some coverage/ideas coming up for some of these that we haven’t already written about. FDA Decisions or FDA […]
PFE & BMY – Quick Update on Pfizer’s and Bristol’s Apixaban
In the past week Bristol Myers Squibb (NYSE:BMY) and Pfizer (NYSE:PFE) have had two notably regulatory events for Apixiban, or ELIQUIS. On November 25th, the National Institute for Health and Clinical Excellence (NICE) made an unusually rapid decision to adopt and cover Apixaban for use by the state health service in the UK. This […]
MNTA – Quick update on Momenta
Yesterday, we saw Momenta Pharmaceuticals (NASDAQ: MNTA) gain 12% on above average volume following some subtle court news that was not picked up by any news providers. Following Momenta’s win in court on October 28th for a preliminary injunction against Amphastar Pharmaceuticals and Watson Pharmaceuticals (NYSE: WPI) over their generic Lovenox, Amphastar filed an emergency […]
ASH Stock Preview
2011 ASH Stock Preview It’s the end of the year, which can mean only one thing- the American Society of Hematology Convention is coming up! ASH is the year’s largest meeting for researchers and investors interested in hematology, or blood cancers. This year’s convention will be held from December 9th through 12th in sunny San […]
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, […]
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 […]
