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 […]
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, […]
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. […]
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, […]
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 […]
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 […]
Biotech IPO’s hot in the first half of 2013
(jointly with Jason Chew and Juan Pedro Rodriguez Serrate) To say biotech IPOs have been hot seems like an understatement. The past year has been an open feeding frenzy for biotech companies looking to raise capital on the public markets. It would seem there is significant pent up pent up supply and demand for these […]
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 […]
Impressions from ASCO 2013 Days 3 and 4
Having survived ASCO 2013, we wanted to review some of the main data from Days 3 and 4. After a very long first 2 sessions, Day 3 and 4 were less data heavy, however, the outcomes from some of these had a dramatic effect for some (like CLVS, INFI, TSRO and SNTA). PD1’s belle of […]
Biggest takeaway from ASCO 2013
With wrapping up our coverage of the 2013 annual meeting of the American Society of Clinical Oncology, I feel compelled to elucidate a point that we tried to hammer home with our preview of this meeting. I attended at least a dozen presentations covering various indications, but nothing compared to the sessions on the developments […]
Flash takes from ASCO 2013 Day 1/2
With Day 1 and 2 of ASCO 2013 completed, we wanted to review some of our main conclusions from the presentations and posters we reviewed. We will try our best given the vast amount of dense information covered during this time. As we previously said, this was largely a conference dominated by newsflow from big […]
ASCO2013 Take Two: Battleground Hematology
As we said in our initial article on ASCO 2013[link], Gilead will have a significant presence at this year’s meeting. In the May 15th press program for ASCO, they will be featuring Idelalisib(GS-1101), Gilead’s delta-specific PI3K inhibitor. Novel oral agents with dramatic efficacy and limited toxicity have made the hematology space highly competitive. Abstracts can […]
Preview of ASCO2013 Take One
With the 2013 annual meeting of the American Society of Clinical Oncology (ASCO) rapidly approaching, we want to take the time to present our highlights of the meeting. This is one of the largest medical meetings investors focus upon in the biotech and healthcare sectors. Before we get into this, we do have some overarching […]
Highlights from Day 2 at Needham
Today marked the end of the 12th Annual Needham Healthcare Conference. Below is a collection of slides from companies that we are following or have an interest in. These include Chelsea Therapeutics (CHTP), Curis (CRIS), Cytokinetics (CYTK), Intercept (ICPT), Omeros (OMER), Sangamo (SGMO), TG Therapeutics (TGTX) and several others. (See our slideshow from Day 1 […]
Some highlights from Day 1 at Needham
The 12th Annual Needham Healthcare Conference began today with a number of presentations by widely biotech companies. Below we have a slideshow of the summary slides from companies that we are following or have an interest in. These include Astex (ASTX), Cubist (CBST), Infinity (INFI), Insmed (INSM), ISIS (ISIS), Sarepta (SRPT) and several others.
Busy week ahead for Biotech
This week is going to be particularly heavy on the earnings updates and FDA actions. Below are some of our views on potential updates and major events at biopharmaceutical companies this week. Additionally, the 12th Annual Needham Healthcare Conference takes place this week from 4/30-5/1. Monday, April 29th Main story for Dynavax will be the potential […]
Upcoming FDA approval decisions
The end of April will be marked by 2 FDA decisions. On Tuesday, April 30th, Raptor Pharmaceuticals (NASDAQ: RPTP) will receive the FDA’s decision on PROCYSBI (RP103, Cysteamine Bitartrate Delayed-Release Capsules) for treating nephropathic cystinosis. The original PDUFA date of 1/30/13 was delayed 3-months following additional data submitted by Raptor. It is a novel reformulation […]
