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| Name | Symbol | Market | Type |
|---|---|---|---|
| Autolus Therapeutics PLC | NASDAQ:AUTL | NASDAQ | Depository Receipt |
| Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| -0.005 | -0.13% | 3.795 | 3.79 | 3.80 | 3.87 | 3.61 | 3.74 | 2,418,375 | 17:54:04 |
From Oct 2023 to Apr 2024
By Chris Wack
Autolus Therapeutics said that the U.S. Food and Drug Administration has accepted its Biologics License Application for obecabtagene autoleucel for patients with relapsed/refractory Adult B-Cell acute lymphoblastic leukemia.
Under the Prescription Drug User Fee Act, the FDA has set a target action date of Nov. 16.
The FDA isn't currently planning to hold an advisory committee meeting to discuss this application.
The BLA submission is based on data from a Phase 2 study of obe-cel in adult r/r B-ALL.
Autolus plans to submit a Marketing Authorization Application for obe-cel in relapsed/refractory ALL to the European Medicines Agency in the first half of 2024.
Obe-cel has been granted Orphan Drug Designation by the FDA and Orphan Medical Product Designation by the EMA.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 22, 2024 07:39 ET (12:39 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.
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