A mixed day in the market which was nice to see a day in which not all stocks were moving in the same direction. Obviously had some stock specific news with AMRN and the PSDV PDUFA and some more general biotech news. 1. AMRN was the stock of the day with about a 67% haircut […]
PSDV ALIM – Analysis of Iluvien for DME
On Thursday, Alimera (ALIM) and Psivida (PSDV) are expected to hear from the FDA on the status of their new drug application(NDA) for Iluvien(fluocinolone acetonide intravitreal implant) to treat chronic diabetic macular edema. With it’s third attempt, one could say Iluvien has taken the long and winding road to approval. The PDUFA date is October […]
ISIS Huntington’s Disease Program: A good start on an ambitious target
Huntington’s Disease (HD) is a neurodegenerative disease characterized by motor, cognitive and psychiatric symptoms. The most typical symptom, but by far not the only, is the occurrence of incontrollable, random and sudden movements (chorea). Symptoms appear around 30 and 40, and the life expectancy after the first manifestations is two decades. Huntington’s is caused by […]
Quick comments on Achillion and TG Therapeutics
(with Jason Chew) In biotech, all too often are investors given news on Friday that is not so good. With many updates expected by the end of the quarter, someone was bound to have the honors of being one of those companies. Today we had quite bad news out of Achillion and an update from […]
What to look for at AASLD 2013
We wanted to take a moment to highlight some of the presentations at the 2013 Annual Meeting of the American Association for the Study of Liver Diseases. This conference takes place Friday, November 1st thru Tuesday, November 5th and covers . Research interest in new therapies against the hepatitis C virus(HCV) still remain high, although […]
What to look for at ESMO 2013
Apropos to our post yesterday on upcoming medical conferences, we wanted to begin with some coverage of the European Cancer Congress 2013 (ECCO-ESMO). This conference takes place Friday, September 27th thru Tuesday, October 1st. Below we have some of the datasets and updates we are looking forward to seeing. ESMO planners also put out their, […]
KaloBios: a look at KB003 and KB004
(jointly with Jason Chew) KaloBios (NASDAQ: KBIO) completed its initial public offering this past January, securing $61.5 million in proceeds to fund operations and it recently raised $30M in a stock offering. In contrast to many companies in this year’s IPO class, KaloBios stock has suffered a drop of about 45% from its $8 debut […]
September 24- EOD
Not a lot going on today, which works out well as it has been a busy day for me outside of biotech. The market seemed to find its footing a little and biotechs appeared (dare I say it) a shade stronger than usual. A day does certainly not make a trend but I suspect that […]
September 24- EOD
Not a lot going on today, which works out well as it has been a busy day for me outside of biotech. The market seemed to find its footing a little and biotechs appeared (dare I say it) a shade stronger than usual. A day does certainly not make a trend but I suspect that […]
September 24- EOD
Not a lot going on today, which works out well as it has been a busy day for me outside of biotech. The market seemed to find its footing a little and biotechs appeared (dare I say it) a shade stronger than usual. A day does certainly not make a trend but I suspect that […]
Upcoming Fall medical conferences
With Fall approaching quickly, we head into one of the busier periods of medical conference presentations. In the next month, we have several widely followed conferences approaching and abstract releases for a number of others. Below are some of the key conferences that we will be tracking with some analysis to follow in subsequent articles. […]
GERN – Quick Take on Geron
Geron shares have run up substantially in recent days on speculation of positive results for its telomerase inhibitor imetelstat in an investigator sponsored study for the treatment of myelofibrosis. During the August 8th Q2 conference call, management noted the second 11 patient cohort had completed enrollment and met the pre-specified criteria of at least 2 […]
MYGN – To Myriad Investors – Your Risks are MyRisk
Co-Author: Dr. Tro Kalayjian Myriad (NASDAQ:MYGN) is a molecular diagnostics company that focuses on the development and marketing of predictive medicine, personalized medicine, and prognostic medicine tests in the United States. Their most well-known tests include BRACAnalysis/ BART, which are tests for hereditary breast and ovarian cancer, and COLARIS, another hereditary cancer test for colon […]
SGMO – Abstracts
The SGMO ICAAC abstracts are now available. This links to the late breaker abstract. Abstract: Background: Expression of CCR5 by CD4 cells is necessary for productive R5 HIV infection. Biallelic KO of CCR5 in CD4 cells by SB-728-T is enhanced in CCR5 Δ32HZ. This study was undertaken to assess the effect of SB-728-T on Δ32HZ, […]
CADX – USPTO deals blow to Cadence
On August 15th, the United States Patent and Trademark Office(USPTO) released their initial office action in response to the Ex Parte Re-examination of U.S. Patent No. 6,028,222. This was done after a 3rd party requested the USPTO re-examine the claims of the patent. The company’s press release failed to convey the seriousness of what occurred, […]
CYTK – Flash note on ATOMIC-AHF data
Today, Amgen (NASDAQ: AMGN) and Cytokinetics (NASDAQ: CYTK) reported data from the Phase IIb ATOMIC-AHF study of i.v. omecamtiv mecarbil (OM) in patients with acute heart failure. As we hypothesized in this piece, only the high dose met the primary endpoint of improvement of dyspnea (breathlessness) after 48 hours, albeit due to a markedly lower […]
RTRX – Notes on Retrophin’s PKAN program
August was a month full of news for Retrophin (RTRX): financing, PR on preclinical results of their PKAN candidate (RE-024), PR on agreement to negotiate a candidate for autism and schizophrenia. In addition, rumors came out on Alexion making an offer for $10 a share, motivated by the strong preclinical results of RE-024. All this […]
Three European biotech companies building value through partnerships
Galapagos NV Galapagos (Brussels: GLPG; Pink Sheets: GLPYY.PK) is a Belgian biotech company whose lead product is JAK1 inhibitor GLPG0634 for rheumatoid arthritis (RA) and Crohn’s disease (CD). Jason covered the drug in this article. Since then, the company has presented more data at various forums; the latest was EULAR in June. They have multiple […]
NLNK – The Fly in the Ointment at NewLink Genetics
NewLink Genetics (NASDAQ: NLNK) is a company which has risen dramatically on the backs of datasets that on the surface may surprise most in the field. These trials have been lauded by executives as game changers and caused much excitement among patient communities. However, upon further review, we believe the data appear seemingly too good […]
SRPT – Sarepta Quick Commentary
It Has Everything And Nothing To Do With Dystrophin Investors have been intensely focused on Sarepta CEO Chris Garabedian’s July 24 “Regulatory Update”, parsing each sentence as if it were one of Bernanke’s speeches. The call went generally as expected: following discussions with the FDA, Sarepta announced plans around an NDA filing based on Phase […]
