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| Name | Symbol | Market | Type |
|---|---|---|---|
| BeiGene Ltd | NASDAQ:BGNE | NASDAQ | Depository Receipt |
| Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| -0.73 | -0.45% | 162.54 | 158.70 | 166.50 | 165.50 | 161.70 | 163.82 | 101,487 | 01:00:00 |
From Jul 2021 to Jul 2024
By Will Feuer
Oncology biotechnology company Beigene Ltd. said the U.S. Food and Drug Administration has deferred action on the company's Biologics License Application for its esophageal cancer treatment due to Covid-19 travel restrictions in China.
The FDA has been unable to conduct required inspections in China due to restrictions there, the company said. As a result, the agency is deferring action on the application until the inspections are complete.
The company's application for a biologics license for its monoclonal antibody tislelizumab to be used as a second-line treatment for patients with metastatic esophageal squamous cell carcinoma remains under review, it said.
"We are working with our partner, Novartis, to facilitate the required inspections and bring tislelizumab to patients with second-line esophageal cancer in the U.S. following regulatory approval," Beigene Chairman and Chief Executive John Oyler said.
Write to Will Feuer at Will.Feuer@wsj.com
(END) Dow Jones Newswires
July 14, 2022 06:33 ET (10:33 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
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