orphan drug designation;
regulatory designations;
economic impact;
pharmaceutical regulation;
small pharmaceutical companies;
D O I:
10.1016/j.drudis.2023.103807
中图分类号:
R9 [药学];
学科分类号:
1007 ;
摘要:
This analysis explores the impact of the FDA's orphan drug designation (ODD) on biotechnology companies' share prices in the short and long term. Our analysis reveals that there is a significant immediate increase in share prices following an ODD announcement, which underscores its potential as a robust indicator of short-term investor returns. However, the long-term findings present a more complex picture, with a sustained impact within the biotech industry but a significant depreciation against the broader market over time. These findings elucidate the nuanced effects of regulatory milestones on the financial performance of pharmaceutical companies and highlight the need for more comprehensive studies to further unravel these complex dynamics.
机构:
US FDA, Off Planning, Off Commissioner, Silver Spring, MD 20993 USA
Univ North Carolina Chapel Hill, Gillings Sch Global Publ Hlth, Dept Hlth Policy & Management, Chapel Hill, NC 27599 USAUS FDA, Off Planning, Off Commissioner, Silver Spring, MD 20993 USA