Why Galera Shares Are Surging More Than Double Today?

Galera Therapeutics Inc GRTX has announced corrected results from its Phase 3 ROMAN trial of avasopasem for RT-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC).
The corrected data showed that avasopasem achieved statistical significance on the primary endpoint of reduction in the incidence of SOM.
Previously it announced that the trial did not achieve statistical significance on the primary endpoint.
An error was identified in the statistical program upon further analysis, resulting in improved p-values.
- 16% relative reduction in the incidence of SOM in the avasopasem treatment group (54%) vs. placebo group (64%) (p=0.0451) (previously p=0.113) (primary endpoint)
- 56% relative reduction in the number of days of SOM in the avasopasem treatment group (8 days) vs. placebo group (18 days) (p=0.0022) (previously p=0.011) (secondary endpoint)
- 27% relative reduction in the severity of SOM in the avasopasem treatment group (24%) vs. placebo group (33%) (p=0.052) (previously p=0.167).
The Company also announced topline results from its single-arm Phase 2a EUSOM trial of avasopasem in Europe.
Avasopasem appeared to be generally well tolerated. In EUSOM, the incidence of SOM was 54.5%, and the median number of days of SOM was 9 days, in line with the ROMAN trial.
Price Action: GRTX shares are up 116.4% at $2.99 during the market session on the last check Tuesday.