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.
Grafico Azioni Bicycle Therapeutics (NASDAQ:BCYC)
Storico
Da Mag 2024 a Giu 2024 Clicca qui per i Grafici di Bicycle Therapeutics
Grafico Azioni Bicycle Therapeutics (NASDAQ:BCYC)
Storico
Da Giu 2023 a Giu 2024 Clicca qui per i Grafici di Bicycle Therapeutics