The annual Leerink Swann Global Healthcare Conference was held February 15-16th, 2012. Several companies that I follow for BiotechDueDiligence and Chimera Research Group presented, and I will summarize the highlights below. Isis Pharmaceutical $ISIS (Archived Chimera content – Pipeline Notes) KYNAMRO (mipomersen) Genzyme/Sanofi are preparing for launch this year. EU application was filed July 2011. […]
NVS – Novartis $440 Million Deal With Enanta- A Shift Away From Nucs
Novartis $440 Million Deal With Enanta- A Shift Away From Nucs The HCV landscape took another turn Tuesday with the announcement that Novartis (NYSE:NVS) had agreed to pay Enanta Pharmaceuticals $34 million upfront and up to $406 million in milestones for their Phase I ready NS5A inhibitor, EDP-239. If not for the HCV setting, this […]
VVUS – Vivus & the FDA; Understanding the Advisory Committee
Our Previous Coverage: Initial Report – 12/16/11 Quick Update 1 – 01/09/12 Last week, the FDA released the briefing documents for an upcoming Advisory Committee meeting set to discuss Vivus’s Qnexa, an investigational compound for the treatment of obesity. Our team combed through over 400 pages of material, in an effort to synthesize this data […]
ARIA – Update on Ariad Pharmaceuticals
Below we have an update on ARIAD Pharmaceuticals(NASDAQ: ARIA) that includes our take on the Ponatinib data at ASH 2011, Ridaforolimus PDUFA thoughts, fourth quarter and full year 2011 updates. Ponatinib At ASH 2011, one of the main presentations to be at was ARIAD’s Ponatinib update,“Initial Findings from the PACE Trial:A Pivotal Phase 2 Study […]
Quick updates from BIO CEO & Investor Conference
The annual BIO CEO & Investor conference was held February 13-14th in New York, a key forum for small biotech companies, especially those that do not receive an invite to the JP Morgan conference in January. Below are some very quick notes from a number of presentations; be sure to note some changes in the […]
INCY – 2011 Q4 Report- Results and Analysis
INCY 2011 Q4 Report- Results and Analysis 2/15/2012 Incyte Pharmaceuticals (NASDAQ:INCY) reported Q4 and full 2011 financials Wednesday morning. Results were pretty much in-line with analyst expectations. Despite management’s repeated statements that uptake of their newly approved myelofibrosis treatment, Jakafi, will be gradual, there are signs that this could be a big year for the […]
SGEN – 2011 Q4 Report: Adcetris Launch On Track
SGEN 2011 Q4 Report: Adcetris Launch On Track 2/13/2012 Well, that certainly didn’t seem to go well. On a day when Regeneron (NASDAQ:REGN) saw its stock jump 12% on better than expected sales guidance of its macular degeneration treatment Eylea, Seattle Genetics (NASDAQ:SGEN) stock tumbled 5% the next day for only meeting quarterly revenue estimates. […]
CELG – Key events for Celgene in 2012
For the most part, investors in Celgene (NASDAQ: CELG) have been fully focused on their blockbuster drug, Revlimid. Celgene recently reported 2011 full year Non-GAAP net sales of $4.6 billion, net income of $1.75 billion(or EPS of $3.79), coming largely from the spectacular growth of Revlimid. With full year 2011 REVLIMID sales of $3.2 billion, […]
Quick take on some upcoming catalysts
With Gilead’s (NASDAQ: GILD) recent announcement about the 7977 data(100% RVR, 25/25 in genotype 1 patients so far) should have Idenix(NASDAQ: IDIX) and Achillion(NASDAQ: ACHN) investors thinking hard about the relative risk-reward at this point. GILD announced that data would be available at CROI12 on March 5th-8th; they plan to annouce more SVR data on […]
MYRX – Myrexis update following earnings release
Myrexis $MYRX (spun off from Myriad Genetics $MYGN and formerly known as Myriad Phamaceuticals), announced fiscal second quarter 2012 earnings on February 9, 2012. A very brief webcast was held, though there was no question and answer session (it was not clear whether there was no one on the line to ask a question, or […]
ANTH – Catalysts Approaching
ANTH: Catalysts Approaching Background: Anthera Pharmaceuticals (NASDAQ:ANTH) began by in-licensing the anti-inflammatory compounds A-001 and prodrug A-002 from Eli Lilly (NYSE:LLY) and Shionogi & Co. in 2006. The company gained worldwide rights to the these sPLA inhibitors, except for Japan, which was retained by Shionogi. A-002, the orally available prodrug of A-001, has completed Phase […]
AMGN, REGN, MNTA & THLD – Quick Updates
Below are some brief note on about a dozen stocks that we felt compelled to brief subscribers on. Today, the briefing documents and panel attendees list for Amgen’s (NASDAQ: AMGN) Xgeva were posted. The panel is schedule for February 8, 2012 with a PDUFA date of April 26, 2012. Amgen hopes to add the indication […]
MDVN – ASCO GU Update
Last night, the abstracts for clinical trials presenting at the 2012 ASCO Genitourinary Cancers Symposium. For now, we want to focus on the most important abstract: Medivation’s (NASDAQ: MDVN) MDV3100 Phase III AFFIRM study of men with castration-resistant prostate cancer(CRPC) that were previously treated with docetaxel. After reviewing the abstract, we believe MDV3100 will replace […]
SNMX – Initiating Coverage on Senomyx
Introduction to Senomyx Senomyx $SNMX is unique from every one of the other companies we cover – while SNMX uses the same tools and techniques of biotech and pharmaceutical drug discovery, they apply these efforts to the discovery of novel food and beverage ingredients. Senomyx develops high throughput assays to screen large compound libraries for […]
CLSN – Quick Take- It’s Bear Territory
CLSN: Quick Take- It’s Bear Territory Overview: Celsion is developing a drug called Thermodox, a heat labile liposomal form of the chemotherapy doxorubicin. Investors are mainly interested in the HEAT trial, a multinational trial in patients with hepatocellular carcinoma (HCC) comparing Thermodox with radiofrequency ablation (RFA) versus RFA alone. The Wrong Endpoint: It does not […]
INFI – Hedgehog inhibitor fails phase 2 trial in pancreatic cancer
Infinity Pharma $INFI announced on January 27th that it was halting a randomized phase 2 trial of the Hedgehog inhibitor saridegib (IPI-926) in metastatic pancreatic cancer, sending the stock down by about 40% to around $6.00 (~$160m market cap). I’ll recap what happened and what is next for INFI based today’s conference call as well […]
