Biogen Inc. (NASDAQ: BIIB) shares were crushed in Thursday’s session after the firm announced that it would be discontinuing its late-stage trial for Alzheimer’s disease. Specifically, the firm is discontinuing its global Phase 3 trials, Engage and Emerge, designed to evaluate the efficacy and safety of aducanumab in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia.
Ultimately, the decision to stop the trials is based on results of a futility analysis conducted by an independent data monitoring committee, which indicated the trials were unlikely to meet their primary endpoint upon completion. The recommendation to stop the studies was not based on safety concerns.
As part of this decision, the Evolve Phase 2 safety study and the long-term extension of the Prime Phase 1b study of aducanumab also will be discontinued. Initiation of the aducanumab Phase 3 secondary prevention trial will be assessed while the data from Engage and Emerge are further evaluated.
Keep in mind that this is a loss of roughly $17 billion from Biogen’s market cap alone.
Michel Vounatsos, CEO at Biogen, commented:
This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience. We are incredibly grateful to all the Alzheimer’s disease patients, their families and the investigators who participated in the trials and contributed greatly to this research. Biogen’s history has been based on pioneering innovation, learning from successes and setbacks. Driven by our steadfast commitment to patients and our strong business foundation, we will continue advancing our pipeline of potential therapies in Alzheimer’s disease and innovative medicines for patients suffering from diseases of high unmet need.
Shares of Biogen were last seen down 28% at $231.73, in a 52-week range of $229.99 to $338.67. The consensus price target is $380.14.