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By Sam Boughedda
Investing.com — Galera Therapeutics Inc (NASDAQ:GRTX) shares jumped more than 144% in early Tuesday trading on the back of amended statistical significance data from its phase 3 trial of its drug to treat those undergoing radiation therapy.
The trial assessed the drug, avasopasem, in treating radiotherapy-induced tissue swelling in the mouth in patients with locally advanced head and neck cancer. The corrected data means the phase 3 trial achieved statistical significance on the primary endpoint of reduction in the incidence of this condition
The FDA has granted avasopasem with Breakthrough Therapy Designation (BTD) for the reduction swelling in the mouth induced by radiotherapy.
Galera had previously announced data that showed statistical significance on the primary endpoint was not achieved.
The company cited an error by the contract research organization. "Correction of this error resulted in improved p-values for the primary and secondary endpoints."