Galera Therapeutics rises as co submits marketing application for oral mucositis drug

Galera Therapeutics

12/12/2022 13:35

** Shares of drug developer Galera Therapeutics Inc  GRTX.O 
gain 8.43% at $1.80 premarket
    ** Co submits marketing application to the U.S. FDA for its
lead drug, avasopasem, for the treatment of radiotherapy-induced
severe oral mucositis in patients with locally advanced head and
neck cancer, which leads to swelling in the mouth
    ** The marketing application is based on data involving end-
and mid-stage studies that enrolled a total of 678 patients
    ** The FDA has granted "fast-track" tag to the drug, says
company
    ** The fast-track tag facilitates development and expedites
review of therapies with the potential to treat a serious
condition where there is an unmet medical need
    ** FDA has also granted avasopasem the "breakthrough
therapy" designation — a tag to expedite the development and
regulatory review of drugs that are intended for serious or
life-threatening conditions
    ** Up to Friday's close, Galera shares down ~64% YTD 
 (Reporting by Sriparna Roy)
 ((Sriparna.Roy@thomsonreuters.com))