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  • BIOBUSINESS BRIEFS

Stock price effects of breakthrough therapy designation

By
  1. David Hoffmann

    1. Institute of Molecular Biotechnology, Vienna, Austria.

  2. Shane Van Dalsem

    1. School of Business, Washburn University, Topeka, KS, USA.

  3. Frank S. David

    1. Pharmagellan, Milton, MA, USA.

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.

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Nature Reviews Drug Discovery 18, 165 (2019)

doi: https://doi.org/10.1038/d41573-019-00019-6

Supplementary Information

  1. 41573_2019_CM16440414_MOESM1_ESM

Competing Interests

F.S.D. works for Pharmagellan, an advisory firm that provides paid consulting services to pharmaceutical and biotechnology companies in areas related to the topics covered in this article.

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