- Galera Therapeutics Inc (NASDAQ:GRTX) stock has plunged to all-time since its listing in November 2019 in reaction to disappointing data from the Phase 3 ROMAN trial of avasopasem manganese in severe oral mucositis (SOM) patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy.
- The trial did not meet its primary endpoint of reduction in the incidence of SOM. The Company continues to analyze the results.
- Key findings:
- 16% relative reduction in the incidence of SOM in the avasopasem treatment group (54%) vs. placebo group (64%), the primary endpoint.
- 56% relative reduction in the number of days of SOM in the avasopasem treatment group (8 days) vs. placebo group (18 days).
- 27% relative reduction in the severity in the avasopasem treatment group (24%) vs. placebo.
- Avasopasem was generally well tolerated with similar rates of adverse events in the active and placebo arms.
- Oral mucositis is a side effect of radiation therapy characterized by severe pain, inflammation, ulceration, and bleeding of the mouth.
- Related: Galera's Lead Candidate Shows Median OS Of 20 Months In Pancreatic Cancer Study.
- Price Action: GRTX shares dropped 70.7% to $2.17 during the premarket session on the last check Tuesday.
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