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 […]
CYTK – Our take on the upcoming ATOMIC-AHF study results
Results from ATOMIC-AHF, a Phase IIb clinical trial of omecamtiv mecarbil, are quickly approaching. Cytokinetics (NASDAQ: CYTK) and partner Amgen (NASDAQ: AMGN) expect to release top-line data around mid-year, probably in June or July. We published a comprehensive analysis of Cytokinetics’ cardiac muscle program in this article. The ATOMIC-AHF study is a double-blind, placebo-controlled clinical […]
INFI – Infinity Pharmaceuticals: Down But Not Out
Less than two months ago on April 2, INFI hit a multi-year high of $50.26. Since then, the stock tumbled more than 50% in a relentless fall driven by high trading volume. Shares recently recovered some and now sit at about $25. Many have argued the stock was overpriced in early April when it carried […]
VICL – Bear take on Allovectin-7
with Patrick Crutcher Vical (NASDAQ: VICL) is approaching the release of top-line data from a Phase III clinical trial of Allovectin-7 (A7) in patients with metastatic melanoma. According to the company’s last earnings call, it’s slated to occur sometime during the third quarter of this year. A7, also known as velimogene aliplasmid, is a DNA […]
GILD – Gilead – Building An Oncology Powerhouse
Having solidified its position as the leading provider of HIV medicines, Gilead turned toward a strategy of diversification, first with pulmonary and cardiovascular disease, then HCV. The first two were mostly busts, but a strong focus on Hepatitis C has paid dividends for stakeholders. Now the company is building on its momentum to create an […]
ASCO2013 Take Three: PD1 antibodies will have significant presence
This is our third piece in a series of articles on developments expected at ASCO 2013[1,2]. Currently, we think the majority of the exciting presentations at ASCO 2013 will be from clinical candidates at big pharma. In particular, anti-programmed death-1 monoclonal antibodies(anti-PD-1) like Bristol Myers’ Nivolumab(BMS-936558), Merck’s Lambrolizumab (MK-3475), GSK’s AMP-224, Teva/CureTech’s CT-011 and Roche/Genentech’s […]
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 […]
GERN – Geron: Time To Turn Out The Lights
Once a high-flying stem cell company, Menlo Park based Geron has fallen on hard times. Year-to-date, shares are off some 25% even as most biotech indices have soared over 20%. The company is in the midst of a restructuring, reducing its workforce from 64 to 44; this is down from 174 employees in November 2011 […]
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 […]
IBB – Biotechnology Index at All Times High
Nasdaq Biotechnology Index Fund ETF (IBB) The best indicator for our biotech portfolio are the biotechnology indexes like IBB, NBI, XBI or XLV. Since we already published “The IBB and SPX In The Decision Zone“, we will maintain our focus on the IBB. By looking at the IBB daily chart, we get the whole picture […]
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 […]
Upcoming earnings and conferences this week
With the first quarter behind us, we look to updates across the biotech industry on new product launches and guidance for the year. We are also coming upon the summer medical conference series. Additionally, we briefly discuss 2 upcoming FDA approvals. Upcoming earnings releases and updates Monday, April 22nd After-Hours: ILMN Tuesday, April 23rd Pre-Market: […]
POZN – Hurdles Lay Ahead For Pozen
We have been actively following Pozen for the last couple years and believe now is a good time to pick up coverage once again. The company submitted an NDA for PA32540/PA8140 only a month ago, a full year after announcing positive top-line results from the second of two Phase III trials. An indication will be […]
Q2 outlook for ARIA, AEGR, CLDX, GHDX, ISIS, MNTA, RPRX, XNPT
First quarter updates for 2013 are on the horizon. Below we outline some of the main events for some biotech companies we’re tracking closely. Aegerion Pharmaceuticals (NASDAQ: AEGR) Most investors will be focused on the how the US launch of Juxtapid(Lomitapide) is tracking. JUXTAPID was approved by the FDA in December 2012. They anticipate a […]
Whats next for ALXN, BMRN, INCY, MDVN, ONXX, REGN, VRTX
First quarter earnings for 2013 are on the horizon. We want to outline some of the main events for some of the larger biotech companies we follow. It can be hard to track the progress of such large companies, but there are meaningful updates still expected in the next 6 months. Alexion Pharmaceuticals (NASDAQ: ALXN) […]
