Bicycle Therapeutics Shares Rise 8% After Continuation of BT8009 Development
September 11 2023 - 10:08AM
Dow Jones News
By Chris Wack
Bicycle Therapeutics shares were up 8% at $22.63 after the
company said it will proceed with its plan to expedite development
of BT8009 for metastatic bladder cancer following recent
discussions with the U.S. Food and Drug Administration.
The biotechnology company has aligned with the FDA on a Phase
2/3 registrational trial that has a design allowing for potential
accelerated approval in untreated and previously treated metastatic
bladder cancer.
Bicycle Therapeutics plans to initiate the trial in the first
quarter of 2024.
The Phase 2/3 trial will assess BT8009 in untreated metastatic
bladder cancer and previously treated metastatic bladder cancer.
Discussions with the FDA about the design of the confirmatory trial
for previously treated metastatic bladder cancer are ongoing.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
September 11, 2023 10:53 ET (14:53 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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