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Bristol-Myers Squibb Misled on Opdivo Drug Trial Securities Class Action

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Investors depend on pharmaceutical companies for accurate descriptions of the findings of their drug trials. Unfortunately, the complaint for this class action claims that Bristol-Myers Squibb Company violated the Securities Exchange Act of 1934 by providing misleading information while its drug trials for cancer drug Opdivo were in progress.

The class for this action is all persons and entities who acquires Bristol-Myers securities between January 27, 2015 and October 9, 2016.

Bristol-Myers Squibb makes and licenses biopharmaceutical products that are sold globally. In January 2015, the company was running its CheckMate-026 study on the use of Opdivo (nivolumab) monotherapy as a first-line therapy in patients with advanced non-small cell lung cancer (NSCLC).

During the class period, according to the complaint, the company’s statements on its 026 trials were optimistic. They included frequent praise for the design of the study and other comments:

  • “[I]t’s our intent to beat chemotherapy, double it” in terms of progression-free survival rates.
  • The study had “been designed appropriately to read out significantly in the next several months.”
  • “The data … suggests that we’re very confident that the study will be a positive study, in particular the characterization of the survival.”
  • “[W]e believe we really have got the optimum balance of speed and the design to deliver positive results in the widest population of first line lung patients…”
  • “And we are increasingly comfortable about the choices we’ve made … as it relates to the efficacy we are seeing, both in the marketplace and in clinical choices.”

On August 5, 2016, however, the company announced that the trial had not met its primary endpoint of progression-free survival. At the news, the company’s stock price declined by 16%, and in subsequent days by another 4.7%.

According to the complaint, however, the company continued to try to mislead the public, claiming that once all the data was released, it would show the efficacy of Opdivo.

On October 9, 2016, the company finally released its analysis of the full data set. In a related conference call, the complaint says it admitted that the trial had failed to demonstrate the efficacy of Opdivo versus chemotherapy. According to the complaint, some analysts believed that the study’s design was flawed and contributed to the trial’s failure. The company’s stock price fell another 10%.

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