Since 2012, the FDA has awarded ‘breakthrough therapy designation’ (BTD) to drug candidates in clinical development that aim to treat serious diseases and have shown preliminary evidence of substantial effects. BTD provides sponsors with more frequent regulatory interactions and senior-level involvement during trial design and execution, submission and review. Prior studies have found that the term ‘breakthrough’ leads the public (
JAMA Intern. Med. 175, 1856–1858; 2015) and physicians (
JAMA 315, 1516–1518; 2016) to have over-optimistic views of a drug’s efficacy. The effect of BTD on investors’ perceptions of recipient firms, however, has not previously been examined.
