Intercept Shares Fall as FDA Rejects Obeticholic Acid New Drug Application
Intercept Shares Fall as FDA Rejects Obeticholic Acid New Drug Application
DJ Intercept Shares Fall as FDA Rejects Obeticholic Acid New Drug Application
By Colin Kellaher
Intercept Pharmaceuticals Inc. on Monday said the U.S. Food and Drug Administration has indicated it won't approve the company's new drug application for obeticholic acid in its current form, sending the company's shares down sharply in premarket trading.
The New York biopharmaceutical company said it received a complete response letter from the FDA in which the agency said it found the predicted benefit of obeticholic acid remains uncertain and doesn't sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to nonalcoholic steatohepatitis, a chronic liver condition commonly known as NASH.
Intercept said the FDA recommended the company submit additional data from its current study of the drug in support of potential accelerated approval, and that the long-term outcomes phase of the study should continue.
Intercept said it is disappointed with the FDA's decision, adding it believes the data it has submitted meet the requirements of the agency's guidance and support the drug's positive benefit-risk profile.
The company said it plans to meet with the FDA as soon as possible to review the letter and to discuss its options for an efficient path to approval.
Shares of Intercept, which closed Friday at $77.49, tumbled 33% to $52.30 in premarket trading.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 29, 2020 07:25 ET (11:25 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
DJ Intercept Shares Fall as FDA Rejects Obeticholic Acid New Drug Application
DJ Intercept 股价下跌，因美国食品药品管理局拒绝奥贝胆酸新药申请
By Colin Kellaher
作者：科林·凯拉赫
Intercept Pharmaceuticals Inc. on Monday said the U.S. Food and Drug Administration has indicated it won't approve the company's new drug application for obeticholic acid in its current form, sending the company's shares down sharply in premarket trading.
Intercept Pharmicals Inc. 周一表示，美国食品药品监督管理局表示不会批准该公司目前形式的奥贝胆酸新药申请，这使该公司的股价在盘前交易中大幅下跌。
The New York biopharmaceutical company said it received a complete response letter from the FDA in which the agency said it found the predicted benefit of obeticholic acid remains uncertain and doesn't sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to nonalcoholic steatohepatitis, a chronic liver condition commonly known as NASH.
这家纽约生物制药公司表示，它收到了美国食品药品管理局的完整回复信，该机构在信中表示，它发现奥贝胆酸的预期益处仍不确定，还不足以超过潜在风险，不足以支持加快批准非酒精性脂肪性肝炎（一种通常称为NASH 的慢性肝病）导致的肝纤维化患者的治疗。
Intercept said the FDA recommended the company submit additional data from its current study of the drug in support of potential accelerated approval, and that the long-term outcomes phase of the study should continue.
Intercept表示，美国食品药品管理局建议该公司提交其目前对该药物的研究的更多数据，以支持可能的加速批准，并且该研究的长期结果阶段应继续下去。
Intercept said it is disappointed with the FDA's decision, adding it believes the data it has submitted meet the requirements of the agency's guidance and support the drug's positive benefit-risk profile.
Intercept表示，它对美国食品药品管理局的决定感到失望，并补充说，它认为其提交的数据符合该机构指导的要求，并支持该药物的积极益处风险状况。
The company said it plans to meet with the FDA as soon as possible to review the letter and to discuss its options for an efficient path to approval.
该公司表示，计划尽快与美国食品药品管理局会面，审查这封信并讨论其有效批准途径的备选方案。
Shares of Intercept, which closed Friday at $77.49, tumbled 33% to $52.30 in premarket trading.
周五收于77.49美元的Intercept的股价在盘前交易中下跌了33％，至52.30美元。
Write to Colin Kellaher at colin.kellaher@wsj.com
通过 colin.kellaher@wsj.com 写信给 Colin Kellaher
(END) Dow Jones Newswires
（END）道琼斯通讯社
June 29, 2020 07:25 ET (11:25 GMT)
美国东部时间 2020 年 6 月 29 日 07:25（格林尼治标准时间 11:25）
Copyright (c) 2020 Dow Jones & Company, Inc.
版权所有 (c) 2020 道琼斯公司
译文内容由第三方软件翻译。
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