The FDA issued a Complete Response Letter (CRL) to Galera Therapeutics Inc's GRTX New Drug Application (NDA) for avasopasem manganese (avasopasem) for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment.
According to the CRL, the FDA remains unconvinced by the Phase 3 ROMAN trial and the GT-201 trial data. They have expressed the need for another clinical study to be convinced of avasopasem's efficacy and safety.
Galera, in response, is seeking a Type A meeting with the FDA to understand their reasoning and determine further steps for NDA resubmission.
They are also contemplating partnership options for avasopasem's continued development.
Galera is also restructuring, reducing its staff by around 70% to extend its financial lifespan. "The focus now is to delineate avasopasem's future and advance the rucosopasem clinical trials," Dr. Sorensen remarked.
Rucosopasem, another promising product by Galera, is intended to enhance the anti-cancer properties of stereotactic body radiation therapy (SBRT) for specific cancer types. The company's GRECO-2 trial hopes to offer a revolutionary treatment option for pancreatic cancer patients.
Galera reported preliminary financials, estimating a balance of $38.8 million. The company forecasts its current funds to support them till the second quarter of 2024.
Price Action: GRTX shares are down 83.40% at $0.37 on the last check Thursday.
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