We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Name | Symbol | Market | Type |
---|---|---|---|
Takeda Pharmaceutical Company Ltd | NYSE:TAK | NYSE | Depository Receipt |
Price Change | % Change | Price | High Price | Low Price | Open Price | Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
0.25 | 1.91% | 13.36 | 4,280 | 12:30:44 |
By Denny Jacob
Takeda Pharmaceutical plans to voluntarily withdraw exkivity following discussions with the Food and Drug Administration.
The company, which develops and manufactures pharmaceutical drugs, said it intends to similarly initiate voluntary withdrawals where the treatment is approved and is working with regulators in other countries where it is available on next steps.
The decision to withdraw was based on the outcome of a Phase 3 trial that didn't meet its primary endpoint, didn't fulfill confirmatory data requirements of the accelerated approval granted by the FDA or the conditional marketing approvals granted in other countries, Takeda said.
The withdrawal of exkivity in the U.S. is for adult patients with epidermal growth factor receptor Exon20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy.
Takeda said it will continue to assess the impact of its withdrawal and will update its outlook for the fiscal year ending March 31 if necessary.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
October 02, 2023 17:01 ET (21:01 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
1 Year Takeda Pharmaceutical Chart |
1 Month Takeda Pharmaceutical Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions