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 美國食品和藥物管理局拒絕藥新藥申請，攔截股價下跌
By Colin Kellaher
由科林·凱拉赫
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.
截取藥品公司週一表示，美國食品和藥物管理局表示，它不會批准該公司目前形式的藥物新藥申請藥物，從而在售前交易中大幅下降該公司的股票。
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.
紐約生物製藥公司表示，它收到了 FDA 的完整回應信，該機構表示，奧替膽酸的預測益處仍然不確定，並且不足以超過支持加速批准的潛在風險，以支持由於非酒精性脂肪性肝炎（一種常稱為 NASH）引起的肝纖維化患者的加速批准。
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，FDA 建議該公司從其目前對該藥物的研究中提交額外數據，以支持潛在的加速審批，並且該研究的長期結果階段應該繼續進行。
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，對 FDA 的決定感到失望，並補充說，它認為它提交的數據符合該機構指導的要求，並支持該藥物的積極收益風險狀況。
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.
該公司表示，計劃盡快與 FDA 會面，以審查這封信並討論其選項，以獲得有效的批准途徑。
Shares of Intercept, which closed Friday at $77.49, tumbled 33% to $52.30 in premarket trading.
截取的股票週五收盤價為 77.49 美元，在盤前交易中跌了 33％，至 52.30 美元。
Write to Colin Kellaher at colin.kellaher@wsj.com
寫信給科林·凱拉赫：colin.kellaher@wsj.com
(END) Dow Jones Newswires
(完) 道瓊斯通訊社
June 29, 2020 07:25 ET (11:25 GMT)
2020 年六月 29 日 07:25 東部時間 (格林威治標準時間 11:25)
Copyright (c) 2020 Dow Jones & Company, Inc.
版權所有 (c) 2020 道瓊斯公司
譯文內容由第三人軟體翻譯。
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