CORRECTION FDA Accepts Autolus Therapeutics' Marketing Application For Obecabtagene Autoleucel For Relapsed/Refractory Adult B-cell Acute Lymphoblastic Leukemia, With Target Action Date Of November 16, 2024
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Autolus Therapeutics plc (NASDAQ:AUTL) has announced that the FDA accepted its BLA for obecabtagene autoleucel (obe-cel), a potential treatment for relapsed/refractory Adult B-cell Acute Lymphoblastic Leukemia (ALL). The FDA has set a PDUFA target action date of November 16, 2024, and does not plan to hold an advisory committee meeting on the application.
January 22, 2024 | 12:07 pm
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Autolus Therapeutics' BLA for obe-cel has been accepted by the FDA, indicating progress in the regulatory process for their therapy for Adult B-cell ALL, with a PDUFA date set for November 16, 2024.
The acceptance of the BLA by the FDA is a positive regulatory milestone for Autolus Therapeutics, indicating that the application is sufficiently complete to permit a substantive review. The set PDUFA date provides a clear timeline for potential approval, and the absence of an advisory committee meeting may suggest a smoother path forward. This news is likely to be viewed positively by investors and could lead to short-term optimism in the stock, given the importance of obe-cel to the company's pipeline.
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