Hammer Stock Blog

Arqule (ARQL) had a quiet 2011 with only two meaningful events, both occurring in January: Initiation of phase III in lung cancer and a public offering. With respect to clinical data, the last meaningful data set was announced in March 2010 in the form of positive phase II results in lung cancer for Arqule’s lead agent, tivantinib (ARQ197). Almost two years later, Arqule returns to investors with more good news, this time in liver cancer. Actual data will be announced only at ASCO in June, however, the limited information provided by the company already positions tivantinib as one of the most promising agents in development for liver cancer. (more…)

Earlier this week, AVEO (AVEO) announced topline results from a phase III trial for tivozanib in renal cancer. Although technically the trial met its primary endpoint and could probably lead to approval, results were far from satisfactory. (more…)

The annual meeting of the American Society of Hematology (ASH) was concluded last week and provided investors a peek into the future of blood cancer treatment. Below are 5 companies that presented promising data that could change the therapeutic landscape in the coming years. (more…)

As far as personalized medicine goes, it doesn’t get any sweeter than Pfizer’s (PFE) Xalkori.  As the industry is moving away from a “one size fits all” model to personalized medicine, this drug sets an enviable example of how to get fast approval for a lucrative niche indication by selecting the right patients. Hailed as the poster child of personalized medicine,  Xalkori is currently approved for lung cancer patients whose tumors have rare mutations in the protein ALK, which occurs in ~4% of non-small cell lung cancer cases. (more…)

Exelixis (EXEL) saw its share price cut in half last week, due to a regulatory setback. Based on what others have published and questions I received there appears to be some confusion with respect to  the implications for the company. I decided to address this issue using a questions and answers format, based on the many inquiries I received. Hope this format sheds some light on the situation.

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It is hard to be neutral on Exelixis’ lead drug - people either love it or hate it. The drug, cabozantinib, got investors and researchers scratching their heads after showing mind boggling activity against bone metastases. The drug led to partial or complete resolution of bone scans in a substantial portion of patients with cancer, including prostate, breast and lung cancer. To my knowledge, this extent of activity has never been observed with approved anti-cancer drugs, all of which rarely affect bone mets. (more…)

Immunogen becomes a $1B company

Immunogen (IMGN) concluded the week with a market cap of ~$1B, up 200% in less than a year. This valuation is quite unusual for a company that ascribes the vast majority of its value from a 3-5% royalty stake in a single drug - Roche’s T-DM1. T-DM1, which utilizes Immunogen’s antibody-drug conjugate (ADC) technology, comprises of Herceptin conjugated to a drug payload. It is in two phase III trials and multiple phase II studies in breast cancer. If proven effective, many believe T-DM1 will eventually replace Herceptin, at least in certain treatment lines.

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One of the questions I am frequently asked is whether there are any good oncology drugs out there which are still available for partnering. The past years saw a surge in licensing and M&A deals, however, there are still several high quality assets out there being developed independently by small or mid cap biotechs. Below are ten companies with promising wholly-owned development stage programs, in alphabetical order.  

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Last week, Exelixis (EXEL) presented updated results for its lead agent cabozantinib (also known as XL184 or “cabo”). Cabo had become a closely watched agent last year after demonstrating unique and unprecedented activity in prostate cancer patients, leading to either partial or complete resolution of bone scans in 19 out of 20 patients. This effect had never been seen with any of the approved or investigational agents for prostate cancer, leading to widespread enthusiasm but also some skepticism.

Following last week’s data, it is now safe to say cabo has a real effect on bone metastases. The data set included 100 response evaluable patients, 62 of whom were evaluable for bone response. 85% of these patients experienced partial or complete resolution of their bone scans (the bone mets shrank or disappeared), 13% had stabilization and 2% (1 patient) had progression. Cabo had a profound effect on bone pain as well as markers for bone metabolism, implying the drug also has potential utility for treating bone related complications.

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Earlier this week, Incyte (INCY) announced positive phase III results for its lead agent, INCB424, in myelofibrosis (MF). Although the full data set was not published, it will almost certainly lead to FDA approval, opening up a $200-$300 market in the US alone. Another similar phase III trial which will be reported in the coming months should support approval in Europe as well.   

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