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Syncona, Arix Note US FDA Acceptance Of Autolus Drug Application

17th Apr 2020 06:08

(Alliance News) - Syncona Ltd and Arix Bioscience PLC on Thursday said that the US Food & Drug

Administration has accepted the investigational new drug application submitted by investee Autolus Therapeutics PLC.

FTSE 250-listed Syncona holds a stake of 28% in Autolus, while Arix has a 6.5% holding.

The healthcare-focused investors said the US regulatory body has accepted the investigational new drug application for AUTO1, a treatment for adults with acute lymphoblastic leukemia. The active application allows initiation of the US sites in Autolus's first study AUTO1-AL1.

Separately, Syncona and Arix noted that Autolus said it does not expect the Covid-19 outbreak to significantly hurt the AUTO1-AL1 clinical study, adding that its manufacturing operations in Stevenage as well as the supply of clinical products to the US - for the treatment of diffuse large B-cell lymphoma patients in its AUTO3-ALEXANDER study - have continued without interruption.

Shares in Syncona closed 4.4% lower at 207.50 pence each on Thursday in London. Arix Bioscience shares closed 2.4% higher at 84.50p each.

By Ife Taiwo; [email protected]

Copyright 2020 Alliance News Limited. All Rights Reserved.


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