Breaking: Galera Therapeutics Tumbles on FDA Setback
- August 09th, 2023
- 216 views
Shares of Galera Therapeutics, Inc.? (Nasdaq: GRTX) plunged over 70% in after-hours trading as the company received a Complete Response Letter (CRL) from the FDA, addressing its New Drug Application (NDA) for avasopasem manganese, a potential treatment for severe oral mucositis in head and neck cancer patients undergoing standard-of-care treatment.
The FDA's communication cited insufficiency in data from the Phase 3 ROMAN trial and supporting GT-201 trial to establish avasopasem's effectiveness and safety. An additional clinical trial will be required for resubmission.
In response, Galera stated its intention to request a Type A meeting with the FDA and outlined plans to enhance financial stability by cutting its workforce by approximately 70%.
$GRTX was trading at $0.38 in after-hours, down $1.85 (-82.59%) following the announcement.
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