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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 | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 3.80 | 3.75 | 3.94 | 0 | 01:00:00 |
From Oct 2023 to Apr 2024
By Colin Kellaher
Autolus Therapeutics has filed for U.S. Food and Drug Administration approval of obecabtagene autoleucel, its lead investigational chimeric antigen receptor T-cell, or CAR-T, therapy, for adult relapsed/refractory B-cell acute lymphoblastic leukemia.
The London-based clinical-stage biopharmaceutical company on Monday said it is also on track to submit a marketing authorization application for the therapy, also known as oba-cel, to the European Medicines Agency in the first half of 2024.
Autolus said its FDA filing is based on data from a pivotal Phase 2 study of oba-cel in patients with the cancer that affects the blood and bone marrow.
Autolus in June said the study had met its primary endpoint, with 76% of dosed patients achieving a complete response or complete response with incomplete haematological recovery.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 27, 2023 07:39 ET (12:39 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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