GRTX - Why Is Cancer Focused Galera Therapeutics Stock Sinking Today? | Benzinga
Galera Therapeutics Inc (NASDAQ: GRTX) received official meeting minutes from the Type A meeting with the FDA held last month.
The FDA reiterated the need for an additional Phase 3 trial of avasopasem manganese (avasopasem) for radiotherapy-induced severe oral mucositis (SOM).
In August, Galera received an FDA Complete Response Letter for avasopasem, citing that the results from the Phase 3 ROMAN trial, together with the supporting data from the GT-201 trial, are not sufficient to establish substantial evidence of avasopasem's effectiveness and safety for reducing severe oral mucositis ...