FOLD: Initiating Coverage Overview: Now here is an interesting story. Amicus Therapeutics was founded in 2002 by serial entrepreneur and CEO John Crowley. He had previously founded Novozyme seeking a treatment for his daughter and son, both diagnosed with Pompe disease. The effort led to the discovery of enzyme replacement therapy, Myozyme, now marketed by […]
AMLN – Neutral/Bearish Trade for PDUFA
Analyst Notes: These kind of things are troubling because of the cardiovascular nature of the FDA’s qualms. However, give it a 50% success probability “In the second CRL, Amylin and its partners were asked to conduct a thorough QT (tQT) study with Bydureon and submit data from the DURATION-5 study which was conducted to compare […]
CBST – 2011 Q4 Quarterly Report Follow-up; Catalysts Through 2012 and Beyond
CBST: 2011 Q4 Quarterly Report Follow-up; Catalysts Through 2012 and Beyond Thursday, January 19 Cubist announced fourth quarter and full-year 2011 results today that surpassed analyst expectations. Excluding one-time costs, quarterly earnings jumped to 66 cents/share from 24 cents the previous year. This was well above consensus estimates of 31 cents. Profit decreased to 11 […]
LXRX – Lexicon Pharmaceuticals is Overvalued
Lexicon Pharma stocks its drug candidate pipeline with a discovery platform based on mouse gene knockout technology, which has allowed them to study the roles of different proteins in disease and select drug targets accordingly. The company’s major clinical programs are headlined by their candidate for type 2 diabetes, LX4211. LXRX has consistently talked about […]
Preview of ASCO 2012 GU Symposium
The 2012 ASCO Genitourinary Cancers Symposium from February 2-4, 2012. The conference is broken down into 3 days focusing on three main areas: Thursday appears dedicated to prostate cancer, Friday is mostly related to urothelial cancers(penile, urethral, urothelial, and testicular), and Saturday is dedicated to kidney cancer. Abstracts will be released on Tuesday, January 31, […]
ASCO Gastrointestinal (GI) Cancer Symposium – Update
Last night (January 17th), the American Society of Clinical Oncology (ASCO) released the full abstracts summarizing the data contained in all presentations at the upcoming ASCO-GI meeting January 19-21, 2012. In our preview post, we highlighted a number of presentations that caught our attention heading into the meeting. Our notes are below; all in all, […]
CBST – Initiating Coverage
CBST: Initiating Coverage Overview: Cubist is a small commercial stage biotech focused on the development of acute care products. Its revenues are almost entirely derived from the antibiotic Cubicin, used for skin and skin-structure infections. The drug has been one of the most successful recent antibiotic launches, allowing Cubist to focus on building up its […]
Anticipated EMA decisions in the first half of 2012
Following our post on upcoming FDA decisions/panel, we wanted to do the same but for European Medicines Agency (EMA) decisions. As you will see, most of the events listed below just have an estimated date by which we will hear an update. This is largely because the way drugs are approved in the EU is […]
ISIS – Research & Development Day Pipeline Recap
Isis Pharma $ISIS held its annual research and development pipeline update for analysts and investors on January 5, 2012. Unfortunately there was no question and answer session, but I’ll review some of the highlights from the two hours of prepared remarks below. An overview of 2012 goals and milestones for the entire antisense pipeline was […]
ACHN & ARIA – Time To Take Some Profits
Both Achillion and Ariad hit 52-week highs today after running up on positive news. While we continue to believe the companies will be successful, we also believe the stocks are getting fairly expensive and think it is a good time to take profits. Since recommending ARIA on November 10th at $10.72, it has gained 31.25% […]
Upcoming FDA Decisions and Advisory Panels
To help save everyone some time, we went ahead and rounded up the upcoming FDA PDUFA dates and FDA Advisory Committees. We will have trade ideas and opinions on some of these events in the near future. We have highlighted some of those which we feel are the biggest importance to the market with asterisks(*). […]
VVUS – Quick Update – Vivus alters NDA for Qnexa, changes REMS
Vivus Pharmaceuticals (NASDAQ:VVUS) reached an agreement today with the FDA, to alter both it’s REMS and Label for obesity drug candidate, Qnexa. Previous Proposed Label Management took a very conservative approach when filing the initial NDA. Given questions about teratogencity of topiramate, one of the active ingredients in Qnexa, Vivus’s management proposed a label that […]
BMY & INHX – Bristol-Myers Squibb Buys Inhibitex for $2.5 Billion
Bristol-Myers Squibb Buys Inhibitex for $2.5 Billion On Saturday, Bristol announced it would acquire Inhibitex for $26 a share, about $2.5 billion dollars, a 163% premium to the companies $9.87 Friday closing price. Inhibitex had been the hot topic of takeover speculation lately for its HCV drug INX-189, a coveted nucleotide polymerase inhibitor. The hepatitis […]
ACHN & INHX: Two HCV Drugmakers In The Spotlight
ACHN v. INHX: Two HCV Drugmakers In The Spotlight Achillion: On Wednesday January 4, Achillion announced it had received Fast-Track designation from the FDA for its experimental HCV drug ACH-1625. A positive development for sure- investors reacted by lifting the stock 1% on a mostly down day for biotechs. Fast Track status is reserved for […]
Biotech catalysts at two upcoming medical conferences
We want to take a moment to highlight two upcoming oncology focused medical conferences that will showcase data that represent potential catalysts for several biotech companies we’re tracking. First up, we have the 2012 ASCO Gastrointestinal Cancers Symposium from January 19-21, 2012. This conference will be focused on developments in the treatment of cancers of […]
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 […]
