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 […]
MACK – Flurry of results in the second half of the year
We would like to take a closer look at the upcoming results of Merrimack Pharmaceuticals’ (MACK) lead drugs, MM-398 and MM-121. MM-398 MM-398 is a liposomal formulation of irinotecan intended for the treatment of pancreatic cancer (PC). Irinotecan is marketed by Pfizer as Camptosar® and approved for first-line treatment of colon cancer in combination with […]
BCRX – BioCryst – Entering The HAE Market
BioCryst announced on Monday July 22 the successful completion of a Phase I study on the safety and PK of BCX4161, a candidate for the treatment of Hereditary angioedema (HAE). HAE is a genetic disorder resulting from the loss or dysfunction of complement C1 Inhibitor (C1INH). Among the functions performed by C1INH is regulation of […]
STML – Follow up on Stemline
In what is becoming increasingly rare these last few months, Stemline made its public debut this January with a drug on track for late stage studies. The company focuses on cancer stem cells, with the clinical candidates SL-401 and SL-701. Today, we will delve into the former, a drug targeted to the IL-3 receptor. Read […]
More biotech IPO’s from the first half of 2013
(jointly with Jason Chew and Juan Pedro Rodriguez Serrate) Today, we continue to highlight some recent biotech/life sciences IPOs. Frankly, our earlier post had a much higher quality group of companies seeking to raise money on the public markets. The companies below all have something about their pipeline or lead products that is in some […]
ASTX – Breaking out of the Downtrend Channel
Astex Pharmaceuticals, Inc. (ASTX) -Nasdaq ASTX had an epic run that started at the end of February from the low of $2.94, just after two months of price consolidation, and reached a six year’s high of $6.95 on April 30, 2012. From that point, the stock started a deep technical correction, trading in a downtrend channel […]
INFI – Infinity Pharma, Staying The Course
This has been one heck of a roller-coaster ride. The stock took 8 months to triple in price, and just 2 to give it all back. Shares began to swoon prior to data presentations at ASCO and ICML. We had expected positive results to soothe the market, but this was not the case. Investors focused […]
July 5- Morning Edition
This is another relatively short note as there is not much news today and I suspect most everyone is enjoying an extended Fourth of July weekend. I just wanted to touch on a couple of points and do so early because my office computer is not working well for some reason. It is a royal […]
SGYP – Cautiously Optimistic On Synergy Pharmaceuticals
We revisit Synergy Pharmaceuticals as the company prepares to initiate a Phase III Chronic Idiopathic Constipation (CIC) study of lead drug plecanatide later this year. Top-line results from the Phase II/III trial were released January 2 early this year, followed by complete data reported at the Digestive Disease Week convention in May. As we had […]
BMY – In A Consolidation Mode
Bristol-Myers Squibb Company (NYSE: BMY) BMY had an amazing run ahead of ASCO-2013 that left many well-planned traders very happy. The stock found strong support near the 50-Day Moving Average around $39.50 where many traders(ourselves included) started initial positions. The stock had a great run into the ASCO abstracts release on May 15th, moving roughly […]
ALNY – Alnylam’s busy summer
Some viewed 2012 as a year of redemption for the field of RNA therapeutics with several notable successes in the sector. This year will likely also mark another important milestone for this specialty sector of the biotech industry. The next 30 days should be rather interesting for Alnylam Pharma (NASDAQ:ALNY) and to some extent Tekmira […]
AEGR – Quick commentary on Aegerion
Aegerion has been one of the best performing stocks over the past 6-12 months. This has been driven by the value creation of Juxtapid (lomitapide), a small molecule microsomal triglyceride transfer protein inhibitor, was approved by the FDA and EMA adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, in […]
