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 […]
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 […]
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 […]
IDIX – Quick chat w/ IDIX CEO Ron Renaud
I had a brief conversation w/ Idenix CEO Ron Renaud this afternoon. Not surprisingly, he was caught up in the deluge of EASL abstracts that were released today. Of particular concern for Idenix was one from Roche involving a trial of their nuc mericitabine and protease inhibitor danoprevir in combination with ribavirin. The trial was […]
IDIX – Is IDX-184 Good Enough?
Idenix may have a new lease on life now that the FDA has lifted all holds on its lead nucleotide IDX184. The company is very keen to put its nuc in combination with a pan-genotypic compound, either a protease inhibitor or NS5a inhibitor. To ensure it doesn’t run into the same toxicity problems it had […]
POZN – Succeeds In Two Pivotal Trials- A Chat With Management:
POZN Succeeds In Two Pivotal Trials- A Chat With Management: (Apologies in advance- no transcript, just some notes.) As we know, Pozen announced yesterday positive top-line results from two pivotal Phase 3 clinical trials of PA32540, a novel, coordinated-delivery tablet of immediate-release omeprazole (40 mg) and delayed release aspirin (325 mg). I spoke briefly with […]
POZN – Focusing on PA32540
POZN: Focusing on PA32540 In Pozen’s last earnings call on February 28, CEO John R. Plachetka told analysts top-line results originally projected for the first half of this year, are now expected in mid-March. Refresher: PA32540 is Pozen’s aspirin/omeprazole co-formulation for the prevention of NSAID-associated upper gastrointestinal (UGI) toxicity. It contains 325 mg aspirin and […]
TZYM – Pivotal Results Approaching
TZYM: Pivotal Results Approaching Durham, North Carolina’s Tranzyme Pharma is a small biotechnology company focused on the development of novel treatments for Gastrointestinal (GI) disorders. Its main product is Ulimorelin for post-operative ileus (POI), a Ghrelin agonist designed to aid the recovery of GI function after bowel surgery. It is set to report results from […]
Could Medivir Be The Next HCV Buyout Target?
Could Medivir Be The Next HCV Buyout Target? Medivir is a small, but highly productive Swedish biotech with a deep pipeline consisting mostly of anti-viral candidates. The most prominent of these is TMC435, an NS3/4 protease inhibitor the company is developing in partnership with Tibotec, a unit of Johnson & Johnson, for the treatment of hepatitis […]
Galapagos JAK1 Inhibitor Is One To Contend With
Galapagos’ JAK1 Inhibitor Is One To Contend With Just today, Galapagos announced a major partnership with Abbott to develop its JAK1 specific inhibitor for the treatment of rheumatoid arthritis. This Belgium based biotech snagged a lucrative deal with $150 million in upfront payments. Upon the completion of Phase II studies, Abbott has the option to […]
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 […]
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. […]
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 […]
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 […]
ONTY – The Bull Case
The Bull Case Note: We at Chimera are not in complete agreement on ONTY. This is my view. Background: Oncothyreon developed Stimuvax, liposome vaccine (L-BLP25), as a cancer vaccine for the treatment of non-small cell lung cancer (NSCLC), breast cancer, and multiple myeloma. It licensed worldwide rights to Merck KGaA, who has now taking over […]
FOLD – Initiating Coverage
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 […]
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 […]
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 […]
