GRTX - FDA rejects Galera's treatment for mouth sores in cancer patients stock -83% after hours

2023-08-09 17:17:06 ET

Galera Therapeutics ( NASDAQ: GRTX ) on Wednesday said its new drug application for its treatment for a radiotherapy-induced complication had been rejected by the U.S. Food and Drug Administration (FDA).

Shares of the micro-cap clinical-stage biopharma cratered 83% to $0.38 after hours.

The FDA issued a so-called complete response letter (CRL) for GRTX's avasopasem agent to treat severe oral mucositis, or painful mouth sores, induced by radiotherapy in patients with head and neck cancer undergoing standard-of-care therapy.

As per the CRL, the FDA believes that the trial data used to support the new drug application (NDA) was not sufficient enough to establish avasopasem's effectiveness and safety for reducing oral mucositis. The regulator has called for results from an additional clinical trial.

"The Company intends to request a Type A meeting with the FDA to understand the FDA’s rationale for its decision and discuss next steps to support an NDA resubmission seeking approval of avasopasem," GRTX said in a statement .

GRTX also said that due to the rejection of the NDA, the company was initiating a restructuring plan that included a workforce reduction by about 70% and a focus of its resources on its second developmental candidate rucosopasem.

GRTX estimated its balance of cash, cash equivalents and marketable securities as of June 30, 2023 to be $38.8M. The company now expects that its current cash will be sufficient to support operations into Q2 2024.

For further details see: