Galera Therapeutics Inc. (GRTX) stock gained a further 7.92% in the after-hours on December 20. During the regular session, the stock saw a huge gain of $28.04% at its close of $3.79. GRTX continued going up in the after-hours, to reach $4.09 at 1.63 million shares.

With no recent news, the stock seems to be gaining on the positive corrected efficacy data published on December 14.

GRTX and its Movement

On December 14, the company announced corrected efficacy data from its Phase 3 ROMAN Trial of Avasopasem. According to this, avasopasem achieved the primary endpoint of statistical significance. The stock has been gaining well on the new data, while it did see profit booking events in the midst of the gains.

On December 20, the stock reached a high of $4.73 at a huge volume of 113.96 million shares. Hence, the day’s volume was a staggering 1,046% of its 65-day average of 10.89 million shares. The stock then continued to gain further in the after-hours on Monday.

Hence, GRXT has added over 174.6% in the past five days alone, making its one-month gain 165.03%. Moreover, the stock has lost 62.95% year to date.

Corrected Topline Efficacy Data

GRXT has been conducting a Phase 3 ROMAN trial of avasopasem for the treatment of RT-induced severe oral mucositis (SOM) in advanced HNC (head and neck cancer) patients. SOM is a side effect of radiation therapy that causes painful mouth sores. These sores cause difficulty and pain in eating and drinking. Moreover, every year almost 42,000 HNC patients undergo RT in the U.S. All these patients are at continuous risk of SOM throughout their treatment. In addition, there are no FDA-approved drugs for SOM reduction or treatment in solid tumors currently.

On Monday, GRTX disclosed corrected topline efficacy data from the trial. According to this, the trial resulted in the achievement of the primary endpoint of statistical significance. Previously, the company had announced that the trial was unable to achieve the endpoint. Moreover, the new data also provided corrected p-values, which are:

• The incidence of SOM reduced by 16%; primary endpoint corrected p=0.0451, against previous p=0.113
• The number of days od SOM reduced by 56%; secondary endpoint p=0.0022, against previous p=0.011
• The severity of SOM reduced by 27%; secondary endpoint p=0.052 against previous p=0.167

In addition, avasopasem was generally well tolerated according to the topline results from Phase 2a EUSOM trial conducted in Europe.