ARNA – Quick take on FDA Adcom

Our coverage of the anti-obesity sector continues. Yesterday, the FDA released the briefing documents regarding Arena’s application for Lorcaserin. Lorcaserin, or Lorqess, is a novel therapeutic candidate for treatment of obesity. Brief History: In 2010, Arena submitted the NDA for Lorcaserin, a subsequent AdCom voted against the application, five on the roster voted for the […]

CLDX – Analysis of Celldex Therapeutics

Celldex Therapeutics (NASDAQ: CLDX)‎ had many biotech investors quite excited for the upcoming 2012 American Society of Clinical Oncology meeting in June, where they had hoped to present initial Phase 2B results of their EMERGE study of CDX-011 in patients with advanced breast cancer. However, news came this morning that a clerical error lead to […]

PLX – Analysis of Protalix BioTherapeutics

It’s 2012 and Protalix BioTherapeutics(AMEX: PLX) Gaucher’s disease treatment, UPLYSO (taliglucerase alfa) is up for approval again. The FDA is set to make a decision on their application tomorrow, May 1st, after delaying the application from February 1st. We think this time around with the FDA will approve Uplyso. UPLYSO was originally granted all the […]

INCY – Summary Q1 2012 Report

Incyte Pharmaceuticals had a very good quarter- the company recorded $25.1 million of total product shipped to distributors, and $19.3 million in net sales. This compares to $2 million in net sales during the last few weeks of Q4 following Jakafi’s FDA approval on November 16 2011. Shares have jumped about 16% the last couple […]

POZN – FDA Asks For More Data

During a pre-submission meeting for the filing of PA32540, the FDA asked Pozen to seek approval for a lower aspirin dosage formulation of 81mg along with their current 325mg. The FDA indicated that without a lower dosage form, it may restrict PA32540’s indication to use in use in post coronary artery bypass graft surgery (CABG) […]

CHTP – Commentary on Chelsea Therapeutics

Chelsea Therapeutics (NASDAQ: CHTP)‎ didn’t quite start 2012 off like some had hoped. On March 28th, the company received a complete response letter on their NDA of Northera (Droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension(NOH). The company plans on discussing what exactly the FDA will require for approval; we imagine they hope the […]

FOLD – Update on Amicus Therapeutics

Investors in Amicus Therapeutics (NASDAQ: FOLD) are anxiously awaiting data from several ongoing trials in rare-diseases. We initiated coverage on Amicus back in January[link]. We are waiting data from the Phase II co-treatment data for Amigal in Fabry disease(Study 013) and the Phase 2 study of AT2220 in combo with enzyme-replacement therapy(ERT) for Pompe disease. […]

GEVA – Hype or Substance?

Synageva shares have risen sharply in the last few months from a low of $8.30 to $38.04 today, now sporting a market cap of $800 million. Its most recent catalyst came on a Morgan Stanley analyst initiation on April 20th with a $76 price target. Synageva has only been a public company for less than […]

PCYC – Update on Pharmacyclics

With the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) rapidly approaching, Pharmacyclics will be providing several updates there that the Street will be watching closely. Their lead drug is a Bruton’s Tyrosine Kinase (Btk) inhibitor for hematological disorders, Ibrutinib(PCI-32765), which is in multiple Phase II trials. PCI-32765 is the company’s major […]

SGEN – Update on Seattle Genetics

A series of recent moves by Seattle Genetics is positioning the company to capitalize on its current success to build for future growth. As previously mentioned in our last report, Seattle Genetics is on track to start three Phase III studies for Adcetris in the front line setting this year: Hodgkin’s Lymphoma (HL), Mature T-cell […]

ARQL – Update on Arqule

We wanted to take some time to review some of Arqule’s (NASDAQ: ARQL) plans going forward in 2012. Management seems more confident than ever in Tivantinib(ARQ197) following their successful Phase 2 in 2nd-line hepatocellular carcinoma(HCC, liver cancer). This success helped convince investors to participate in their recent 7.1M share offering that brought in around $48.7 […]

IDIX – Interview With CEO Ron Renaud

Idenix CEO Ron Renaud Q&A  April 11, 2012 Idenix has been the subject of considerable attention with EASL (The European Association for the Study of the Liver) approaching and embargoed abstracts flying around the web. The company’s shares have been battered, dropping nearly 50% from January highs as questions have arisen over the potency of […]