Breaking: Galera Therapeutics Tumbles on FDA Setback
- August 09th, 2023
- 540 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.
THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY OR DIGITAL ASSET. Please consult with a professional investment advisor before purchasing or selling any securities viewed on or mentioned herein. (Read Full Disclaimer)
Post Your Comments
Want To Find Some News?
Recent Posts
-
FTC Takes Action to Prevent Anticompetitive Arrangement in Beretta, Ruger Deal
September 16th, 2026Why Opponent Preparation Matters for Post-Graduate Athletes
September 16th, 2026The Work Behind the Game: How Football Teams Prepare to Compete
September 15th, 2026NJCP Operates on a Prep Model Built Around a Full Season
September 14th, 2026Earnings Preview: High Tide, Kestra Medical, and RF Industries in Focus
September 12th, 2026
Member Login