Galera Therapeutics Implements Restructuring Plan After FDA Rejection


Galera Therapeutics, a biotechnology company, has undertaken a significant restructuring effort after the U.S. Food and Drug Administration (FDA) rejected its avasopasem manganese treatment for radiotherapy-induced severe oral mucositis in patients with head and neck cancer. The rejection led to an 83% drop in Galera’s shares in after-hours trading.

The FDA’s Complete Response Letter cited inadequate persuasive data from Galera, prompting the need for additional trial results if the company seeks to resubmit its application. The avasopasem manganese New Drug Application was supported by Phase III ROMAN study data, revealing a significant reduction in severe oral mucositis incidence. The Phase IIb GT-201 trial also corroborated these findings.

Galera CEO Mel Sorensen expressed disappointment over the FDA’s decision and announced the company’s intent to request a Type A meeting to comprehend the rejection and chart potential paths forward.

Avasopasem manganese functions as a selective dismutase mimetic, converting superoxide into hydrogen peroxide to enhance cancer cell sensitivity to radiation while safeguarding healthy cells. This mechanism holds promise for patients enduring radiation-related severe oral mucositis, an area currently lacking approved treatments.

To navigate its future course, Galera initiated a comprehensive restructuring plan involving staff reductions of approximately 70% across multiple departments. The company aims to allocate resources to advancing the clinical trials of its second candidate, rucosopasem, designed to enhance anti-cancer effects in non-small cell lung cancer and advanced pancreatic cancer through stereotactic body radiation therapy.

The restructuring seeks to optimize Galera’s operations while focusing on its promising pipeline, with available cash, cash equivalents, and marketable securities estimated at around $38.8 million, sustaining the company through the second quarter of 2024.

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