Galera Therapeutics, Inc. (NASDAQ: GRTX) is engaged as a clinical-stage biopharmaceutical company, which is focused on the research, development and commercialization of novel therapeutics to help transform radiotherapy for cancer. Shares of the biopharma company are skyrocketing 105% through early trading on Tuesday, December 14, 2021. Over the past three months, Galera Therapeutics has seen average daily volume of 3.05 million shares. However, volume of 184.7 million shares or dollar volume of around $555.95 million, has already exchanged hands through early trading Tuesday.
Shares of Galera Therapeutics are soaring after the company reported corrected Phase 3 ROMAN trial data of Avasopasem, a treatment for RT-induced severe oral mucositis (SOM) in patients suffering from neck or head cancer. The corrected topline data showed that the trial’s primary endpoint saw statistical significance with its ability to reduce radiotherapy-induced severe oral mucositis. As a result, the FDA has granted Avasopasem Breakthrough Therapy Designation (BTD).
In the corrected results, the treatment group saw a 16% relative reduction of SOM versus the placebo group. Furthermore the treatment group saw a 56% relative reduction in the number of days with SOM compared to the placebo group. Lastly, the treatment group saw 27% less severity of SOM compared to the control group.
Roughly 42,000 patients with head or neck cancer undergo standard radiotherapy each year in the U.S. and are at risk of developing SOM. This causes painful mouth sores that limit the ability to eat and drink. Currently, there are no FDA-approved treatments to reduce the severity or duration of SOM in solid tumors.
“Given the high unmet medical need for patients with head and neck cancer who develop radiotherapy-induced severe oral mucositis, we are gratified that the Phase 3 ROMAN trial achieved statistical significance on the primary endpoint after the correction of the statistical programming error,” said Mel Sorensen, M.D., President and CEO of Galera. “ROMAN is our second randomized trial conducted in patients with head and neck cancer to achieve statistical significance and demonstrate improved clinical benefit. As we continue to analyze the full data set and evaluate our resources, we look forward to meeting with the FDA in 2022 to discuss whether the results from this single Phase 3 trial together with the randomized Phase 2b trial could support an NDA submission.”
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