投资者是否看重美国食品药品监督管理局（FDA）的孤儿药认定？
Do investors value the FDA orphan drug designation?
作者信息
Miller Kathleen L
机构信息
Office of Planning, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.
Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
出版信息
Orphanet J Rare Dis. 2017 Jun 19;12(1):114. doi: 10.1186/s13023-017-0665-6.
BACKGROUND
The Orphan Drug Act is an important piece of legislation that uses financial incentives to encourage the development of drugs that treat rare diseases. This analysis studies the effects of a portion of the Orphan Drug Act, the orphan drug designation. Specifically, it studies the value that investors place on the orphan drug designation, by investigating how investors react to companies' announcing that their product has received the designation.
RESULTS
The results, on average, show that the stock price of a company increases by 3.36% after the announcement of the designation, increasing the value of the company. The results are more pronounced for oncology drugs, and drugs being developed by the smallest companies.
CONCLUSION
The orphan designation appears to be successful at generating positive value for companies, as seen by the positive and significant average increases in stock price.
背景
《孤儿药法案》是一项重要的立法，它通过经济激励措施鼓励研发治疗罕见病的药物。本分析研究了《孤儿药法案》的一部分，即孤儿药认定的影响。具体而言，通过调查投资者对公司宣布其产品已获得该认定的反应，研究投资者对孤儿药认定的重视程度。
结果
平均而言，结果表明公司宣布获得认定后，股价上涨3.36%，公司价值增加。对于肿瘤药物以及最小规模公司正在研发的药物，结果更为显著。
结论
从股价平均出现正向且显著的上涨可以看出，孤儿药认定似乎成功地为公司创造了积极价值。
Zotero 插件