Galera Receives Complete Response Letter From U.S. FDA for Avasopasem Manganese; The Co Intends To Request A Type A Meeting With The FDA To Understand The FDA's Rationale For Its Decision
Portfolio Pulse from Happy Mohamed
Galera Therapeutics, Inc. (NASDAQ:GRTX) has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for avasopasem manganese, a treatment for radiotherapy-induced severe oral mucositis. The FDA stated that additional clinical trial results will be required for resubmission. Galera plans to request a Type A meeting with the FDA to discuss the decision and next steps. The company also plans to reduce its workforce by approximately 70% to extend its cash runway.
August 09, 2023 | 8:35 pm
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Galera Therapeutics' stock may be negatively impacted in the short term due to the FDA's decision and the planned workforce reduction.
The FDA's decision to require additional clinical trial results for avasopasem manganese could delay its approval, potentially impacting Galera's revenues. The planned workforce reduction, while aimed at extending the company's cash runway, could also impact its operations and investor sentiment.
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