Eli Lilly & Co. (NYSE: LLY) is watching its shares in free fall on Wednesday, not from any election or political concerns but a late-stage trial failure. As we have said time and again, clinical trials can make or break Biotech and Pharma companies, and in this case Eli Lilly hit new 52-week lows, not seen since 2014. This won’t be a loss that Eli Lilly will forget anytime soon. Effectively, the company announced results from its Phase 3 solanezumab trial in people with mild dementia due to Alzheimer’s disease (AD).
Keep in mind that Eli Lilly has a strong pipeline outside of this AD treatment, but the fact that solanezumab made it to Phase 3 for this indication means that Eli Lilly has already sunk millions into the study. Perhaps money that it won’t get back.
Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline when compared with patients in the placebo arm of the study.
Although the study results, which included many secondary clinical endpoints, favored solanezumab, the treatment did not make significant differences enough to warrant continuing the study. Eli Lilly has decided that it will not pursue regulatory submissions for solanezumab for the treatment of mild dementia due to Alzheimer’s disease.
Eli Lilly will present further findings from the study at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting on Thursday, December 8.
John C. Lechleiter, Ph.D., Chairman, President and CEO of Eli Lilly, commented:
The results of the solanezumab EXPEDITION3 trial were not what we had hoped for and we are disappointed for the millions of people waiting for a potential disease-modifying treatment for Alzheimer’s disease. We will evaluate the impact of these results on the development plans for solanezumab and our other Alzheimer’s pipeline assets.
Excluding Wednesday’s move, Eli Lilly has underperformed the broad markets with the stock down about 10% year to date.
Shares of Eli Lilly were last trading down 13% at $66.01, with a consensus analyst price target of $97.05 and a 52-week trading range of $64.18 to $88.16.