Galera Therapeutics (GRTX) Company Overview

We look at a few biotech companies, LEGN, KOD, GRTX, which are poised to beat second-quarter earnings estimates.

Galera Therapeutics shares plunged by almost 85% after the clinical-stage biopharmaceutical company revealed its New Drug Application for its investigational therapeutic avasopasem manganese (avasopasem) for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment was not approved by the Food and Drug Administration (FDA).  The company said that the FDA had informed it that the data from its Phase 3 ROMAN trial and supporting data from its GT-201 trial were “not sufficiently persuasive to establish substantial evidence of avasopasem's effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer.

Galera Therapeutics (NASDAQ: GRTX ) stock is falling hard on Thursday following a drug rejection by the FDA! In a Complete Response Letter ( CRL ), the FDA rejected the company's New Drug Application (NDA) for avasopasem manganese.

Galera Therapeutics Inc said the U.S. health regulator declined to approve its drug to treat radiotherapy-induced severe mouth inflammation in patients with advanced head and neck cancer undergoing standard-of-care treatment.