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) […]
Three bloated valuations with approaching exclusivity and patent expirations
With the strong performance of pharmaceutical and biotechnology stocks over the past few years, some have even outperformed expectations. Specialty pharmaceutical companies have filled various niches recently with reformulated products for various indications. However, at some point, their valuations exceed the fair value of their respective opportunities and do not account for the risks they […]
ACHN – Sell Achillion, Buy Idenix
A lot has happened since we last discussed HCV stocks back in October ahead of AASLD. One thing that remains unchanged is Gilead’s dominant lead in the development of next-generation HCV drugs. Beating expectations, Gilead is set to submit its regulatory filing of an all-oral combo consisting of sofosbuvir and GS-5885 by mid-2014 with potential […]
AVEO – An analysis of Aveo’s upcoming advisory committee
(in collaboration with Juan Pedro Rodriguez Serrate) The FDA’s Oncologic Drugs Advisory Committee (ODAC) is slated to review AVEO Oncology (NASDAQ: AVEO) / Astellas Pharmaceuticals’ Tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC) during the morning session of its meeting on May 2, 2013. An FDA decision is expected by Jul […]
ECYT – Update on Endocyte
It’s been awhile, but we wanted to update our coverage on Endocyte (NASDAQ: ECYT). Endocyte has a novel small molecule drug conjugates or SMDCs, and companion imaging diagnostics; think Seattle Genetics(NASDAQ: SGEN), but given orally. Endocyte expects that its cash will be between $145-160 million at the end of this year. Following the strong move […]
DCTH – Our take on Delcath’s upcoming advisory committee
The FDA’s Oncologic Drugs Advisory Committee (ODAC) is slated to review Melblez (previously known as Chemosat) on May 2nd. An FDA decision is expected on June 15th. Melblez is a chemosaturation system that isolates the liver in order to allow the administration of high doses of melphalan for the treatment of liver metastases from other […]
CRIS – Curis Pipeline May Propel Shares
Curis is best known for its hedgehog (Hh) pathway inhibitor Erivedge, which has been licensed to Genentech (Roche). Erivedge was approved for the treatment of inoperable basal cell carcinoma (BCC) in January 2012. The launch has been slow; sales reached only $30.6 million last year. Partnered early, Curis receives only 5% royalties, escalating to high […]
Recent Biotech IPOs
We want to highlight some biotech companies that have recently come public. The end of 2012 and continuing into the spring of 2013 brought forward a number of companies in search of new funding across various stages of development(Phase 1-3). Initially, shares in these companies will be rather illiquid, so expect to see some volatility. […]
ASTX – Astex Is One To Watch
Astex Pharmaceuticals is a promising small cap biotech company with both a marketed drug and pipeline products waiting in the wings. The Dublin, CA based company generates royalty revenue from sales of hypomethylating agent Dacogen (decitabine) for the treatment of AML and MDS. In recent years, the growing revenue stream has helped offset research spending […]
