Biogen's stock lost $30B of market value when it announced the study failure. Because aducanumab is potentially the first disease-modifying treatment for Alzheimer's, it could be one of the best-selling drugs of all time. This was shocking because a few months prior, Biogen announced it was stopping development of this drug because one of its pivotal trials failed - their drug did no better than placebo at improving Alzheimer's symptoms like dementia. In October 2019, Biogen announced that it was submitting its potential Alzheimer’s drug, aducanumab, for FDA approval. I have no position in Biogen or intention of initiating a position in the near future. It isn't meant to be a definitive or expert analysis, nor is it an investment recommendation. I'll note that this is intended to be an introduction to analyzing clinical trials through a real life analysis. I'll walk through my interpretation of the data, and hopefully will provide enough context for you to draw your own conclusions. Then we will walk through the slides that Biogen used to announce what STAT News calls “the most shocking biotech news in all of 2019”: Biogen's decision to submit aducanumab for approval, just months after announcing it was canceling the program after a failed pivotal study (STAT’s podcast on this topic is well worth a listen). In this post, I'll provide a bit of background on the aducanumab situation. Aducanumab is being developed as a treatment for Alzheimer's disease, and could be the first disease-modifying therapy for one of the largest and fastest growing causes of death in the US.īut does it work? That is one of the biggest questions in the biotech world today. In this post, we'll introduce basic concepts in interpreting clinical data using a real-world example: a case study of Biogen's aducanumab. Data dredging or a $50B drug: an intro to interpreting clinical data
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