Galera soars after corrected late-stage trial data on lead drug

Galera Therapeutics

14/12/2021 12:46

** Shares of drug developer Galera Therapeutics  GRTX.O 
jumps ~81% to $2.50 premarket- its highest in nearly two months 
    ** Co announces corrected positive results from its
late-stage study of lead drug candidate, Avasopasem, for the
treatment of radiotherapy-induced severe oral mucositis (SOM) in
patients with locally advanced head and neck cancer  urn:newsml:reuters.com:*:nGNXp35Yp 
    ** SOM is a common debilitating complication of cancer
treatments like radiation therapy or chemotherapy, leading to
tissue swelling in the mouth
    ** Data shows Avasopasem achieved statistical significance
on the main goal of reduction in the incidence of SOM
    ** Co in October said that the drug did not achieve
statistical significance on the main goal in the late-stage
study  urn:newsml:reuters.com:*:nL4N2RF3PR 
    ** Upon further analysis, an error by the contract research
organization was identified in the statistical program that
resulted in the previous incorrect data – GRTX
    ** Correction of the error resulted in improved p-values for
the primary and secondary goals
    ** GRTX plans to discuss the corrected data with the U.S.
FDA next year, to understand whether it could support a
marketing application submission for Avasopasem
    ** Up to Monday's close, stock had fallen 86.51% YTD 

 (Reporting by Oishee Majumdar in Bengaluru)
 ((oishee.majumdar@thomsonreuters.com;))