Galera Therapeutics announces FDA priority review of NDA for avasopasem in SOM; PDUFA date Aug 9, 2023

Galera Therapeutics, Inc.

FDA accepted NDA for avasopasem manganese for radiotherapy-induced severe oral mucositis in head/neck cancer.
Priority review assigned; PDUFA target action date of August 9, 2023; no advisory committee meeting planned.
Company estimates total US market opportunity for SOM exceeds $1 billion.
Preliminary cash and investments balance of ~$31.6M as of Dec 31, 2022; audited results pending.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.