Hammer Stock Blog

Last week, Roche announced that the FDA was unwilling to accept T-DM1’s accelerated approval filing for breast cancer, sending Immunogen’s (IMGN) shares tumbling almost 40%. The filing was based on impressive results from a single arm phase II trial in 3^rd line HER2 breast cancer. Typically, gaining regulatory approval requires a large, randomized phase III study but in cases of highly unmet need where patients are bereft of effective treatment options, the FDA may consider approval in a limited patient population.

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Synta (SNTA) is recuperating nicely from last year’s meltdown following the failure of its melanoma drug, elesclomol. The company is gaining momentum thanks to its early stage Hsp90 (heat shock protein 90) inhibitor, STA-9090. STA-9090 seems to garner a lot of attention in the medical community following the presentation of encouraging phase I data at ASCO last June. Based on the preliminary results, STA-9090 could be what the industry has been waiting for: An broad and potent Hsp90 with an acceptable safety profile.

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Exelixis (EXEL) came under a lot of pressure recently and the stock is now trading near its 52 week low following two unrelated events that took place last month. In late June, the company announced the resignation of its CEO, George Scangos, who was appointed as Biogen Idec’s (BIIB) CEO. Earlier that month, the company announced BMS (BMY) decided to give back rights for Exelixis’ flagship product, XL184. Adding to the pressure are interesting but not stellar clinical results for some of the company’s compounds at ASCO and potentially an additional partnership termination. (more…)

The hottest theme at this year’s 2010 ASCO (American Society of Clinical Oncology) annual meeting was without a doubt cancer immunotherapy, an old paradigm that deals with redirecting the patient’s immune system against tumors. After decades of failures, this concept is finally proving itself useful. There are basically two approaches:  1) cancer vaccines that aim at eliciting an immune response against specific targets on cancer cells and 2) immunomodulatory drugs that aim at stimulating the immune system in a more general manner (not target specific). The undisputed leader in cancer vaccines is Dendreon (DNDN), which currently has the only FDA approved cancer vaccine. Following ASCO, it looks like the leader in immunomodulation drugs is BMS (BMY).

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