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.

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