Galera implodes, as FDA slaps CRL on avasopasem NDA

10 August 2023

The US Food and Drug Administration (FDA) yesterday issued a Complete Response Letter (CRL) regarding US drug developer Galera Therapeutics (Nasdaq: GRTX) New Drug Application (NDA) for avasopasem manganese for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment.

The news sent company shares diving 82% to $0.40 in after-hours trade.

The CRL said that the results from the Phase III ROMAN trial together with the supporting data from the GT-201 trial are not sufficiently persuasive to establish substantial evidence of avasopasem’s effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer. FDA stated that results from an additional clinical trial will be required for resubmission.

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