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 […]

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: […]

AASLD 2012 – An HCV Primer

It seems EASL has just ended, but AASLD is fast approaching, coming mid November. For HepC watchers, here is an overview of some companies that will be presenting at the Liver Meeting. Despite the tremendous progress made to-date, new advances keep it exciting. Gilead: Acknowledged leader in the race to bring an all-oral drug combination […]

IDIX – Quick Take on IDX184

Idenix released SVR4 data for its lead drug IDX184 and early 3-day results of the promising NS5A inhibitor IDX719 Tuesday afternoon. Both sets of data looked good, sending IDIX shares soaring in after-hours trading. 31 patients from the first cohort of Idenix’s Phase IIb study were randomized to either 50mg (n=16) or 100mg (n=15) IDX184 […]

EASL – A Look Back- Lessons Learned

There were some early winners and losers this year at EASL. Here we examine a few new interferon-free combination treatments, the most exciting development in HCV today; and look outward to determine how the future may shape up. The Good News: The star of the stage, once again, was GS-7977 (formerly PSI-7977). Gilead’s nucleotide polymerase […]

IDIX – The Patent Interference Case

In early March, Idenix announced the USPTO (US Patent and Trademark Office) had declared a patent interference between its U.S. Patent Application no. 12/131,868 and Pharmasset’s (now Gilead’s) U.S. Patent no. 7,429,572. Idenix, with the earlier filing date, has been designated the senior party in this dispute, where the principal issue is to determine priority […]

IDIX – Is IDX-184 Good Enough?

Idenix may have a new lease on life now that the FDA has lifted all holds on its lead nucleotide IDX184. The company is very keen to put its nuc in combination with a pan-genotypic compound, either a protease inhibitor or NS5a inhibitor. To ensure it doesn’t run into the same toxicity problems it had […]

Quick take on some upcoming catalysts

With Gilead’s (NASDAQ: GILD) recent announcement about the 7977 data(100% RVR, 25/25 in genotype 1 patients so far) should have Idenix(NASDAQ: IDIX) and Achillion(NASDAQ: ACHN) investors thinking hard about the relative risk-reward at this point. GILD announced that data would be available at CROI12 on March 5th-8th; they plan to annouce more SVR data on […]

ACHN – Initiating Coverage

Achillion: Initiating Coverage Background: Achillion is a small biotech focused on the development of a cure for Hepatitis C. It has several compounds in its pipeline, all unpartnered. The two leading products are next-generation protease inhibitors, ACH-1625 and ACH-2684, followed up by a duo of NS5A inhibitors, ACH-2928 and ACH-3102. There has been considerable M&A […]

Is Pharmasset The Next Gilead?

Private: Patrick Crutcher

The HCV landscape is looking eerily similar to that of HIV treatments at its infancy, with a few differences. While the development of drugs for HIV took off quickly after identification of the disease, only now are truly effective therapies coming to market for HCV, led by pioneering work from Vertex. HIV drug development was […]

Where Is Lilly In The PI3K Race?

Some 15 years ago, scientists at Eli Lilly discovered the first PI3kinase inhibitor, code name LY294002. Although only of modest potency and selectivity, it became widely used by the research community as a tool compound to elucidate the PI3K pathway. In recent years, the field has taken off with compounds in development for oncology and […]

Gilead Is On A Roll

It appears the tide is finally turning for Gilead Pharmaceuticals. After hitting a 52-week low of $31.76 in late August 2010, it has since rallied 30% to reach $41.30 on news of successful Phase III trials of its integrase inhibitor, though that is still well below the stock’s $48.44 high from March last year. Gilead […]