AMRN – Will AMR101 receive New Chemical Entity (NCE) Status from the FDA?
Why does this question of New Chemical Entity (NCE) status matter? Simply put, if AMR101 is designated as a New Chemical Entity (NCE) by the FDA, the product receives five years of market exclusivity after approval in the United States, regardless of the patent situation (sometimes referred to as Hatch-Waxman exclusivity). During this time the FDA will […]
AVEO – Quick take on top-line data
AVEO Pharmaceuticals(NASDAQ: AVEO) kicked off the 2012 trading year with news from their Phase 3 trial, TIVO-1. AVEO announced that Tivozanib had demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in TIVO-1, a global, randomized Phase 3 clinical trial evaluating the efficacy and safety of Tivozanib compared to Nexavar(sorafenib) in patients […]
POZN – Interview With POZN CEO John Plachetka and COO Liz Cermak
Interview With POZN CEO John Plachetka and COO Liz Cermak After seeing its shares slide for much of the year, Pozen stock jumped 46% when it struck a deal to sell the right to its royalties from the migraine drug Treximate to CPPIB Credit Investments Inc. for $75 million. Pozen will now end the year […]
AIS – “Lies, Damn Lies, and Statistics”
Anatres Pharma (AIS) has been the subject of biotech stock buzz lately, due to two closely spaced news events concerning the company’s proprietary topical gel products. The failure of LibiGel, a testosterone product for female sexual dysfunction, in phase 3 efficacy trials conducted by their partner BioSante Pharma (BPAX), has grabbed the headlines. While that […]
MITI – Initiate Coverage
Micromet: Initiate Coverage Background: Micromet specializes in the development of cancer drugs based on a new class of therapeutics called “bispecific antibodies.” These novel antibodies are capable of recognizing and binding two different antigens and have been termed “bispecific T-cell engagers” or BiTE antibodies. Bispecific antibodies are part of a new generation of more advanced […]
VRUS – Pharmasset Halts Trial- And The Winner Is…
Pharmasset, a leader in the development of next generation HCV treatments, took a stumble today as it announced the halt of all trials involving its drug PSI-938 due to possible liver toxicities. This compound is the second of Pharmasset’s two nucleotide analog polymerase inhibitors (nuc) and further behind in the clinic. The more advanced compound, […]
VVUS – Vivus Pharmaceuticals – Initiating Covereage – Neutral
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 […]
BPAX: Trade Idea for LibiGel Phase 3 Data (#2)
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AFFY – AdCom Trading Strategies (#2)
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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 […]
