Biotechnology and small pharma companies must recognize the opportunity presented by FDA Breakthrough Therapy Designation (BTD) to expedite drug development for serious conditions. This paper evaluates BTD economic and developmental impacts on such companies. Analysis of 29 BTD events from 2017 to 2022 revealed immediate share price boosts and improved drug approval rates, alongside faster development times. Yet, long-term share prices underperformed relative to the broader market, underscoring the persistent risks in pharma investments. Although offering new insights, the limited sample size calls for further investigation.

中文翻译：

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揭示 FDA 突破性疗法认定的影响：生物技术公司经济和发展成果的双重视角审查

生物技术和小型制药公司必须认识到 FDA 突破性治疗指定 (BTD) 提供的机会，以加快针对严重疾病的药物开发。本文评估了 BTD 对此类公司的经济和发展影响。对 2017 年至 2022 年 29 个 BTD 事件的分析显示，股价立即上涨，药物批准率提高，同时开发时间加快。然而，长期股价相对于大盘表现不佳，凸显了制药投资持续存在的风险。尽管提供了新的见解，但有限的样本量需要进一步研究。