Galera Therapeutics shares plunged by almost 85% after the clinical-stage biopharmaceutical company revealed its New Drug Application for its investigational therapeutic avasopasem manganese (avasopasem) for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment was not approved by the Food and Drug Administration (FDA).
The company said that the FDA had informed it that the data from its Phase 3 ROMAN trial and supporting data from its GT-201 trial were “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.”
The FDA said that the results from an additional clinical trial would be required for Galera to resubmit its New Drug Application, the company noted.
Galera intends to meet with the FDA as soon as possible to discuss the next steps regarding resubmission and said that it will take actions to extend its cash runway and continue enrollment in its rucosopasem clinical trials.
As a result, the company said it would be slashing its workforce by approximately 70% and winding down its commercial readiness efforts.
“We continue to believe in avasopasem’s potential to bring a meaningful benefit to these patients who currently have no FDA-approved drugs for this debilitating condition,” Galera CEO Dr. Mel Sorensen said in a statement.
Galera shares had fallen 84.1% at US$0.36 in the early afternoon on Thursday.
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