By Denny Jacob
Galera Therapeutics shares plummeted 82% to 38 cents following a decision by the Food and Drug Administration regarding the company’s new drug application for its cancer drug avasopasem manganese.
The stock, which closed up 6.2% to $2.24, is down 83% on the year.
The clinical-stage biopharmaceutical company said it will reduce its workforce by 70% as part of a broader restructuring to extend its cash runway following the decision. Galera said the FDA stated that trial data of avasopasem’s effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer wasn’t sufficiently persuasive. The company intends to request a Type A meeting with the FDA to discuss the rationale of the decision, and next steps to support a new drug application resubmission for approval.
Other aspects of its restructuring includes a wind-down of commercial readiness efforts. Galera said it will focus resources to define the path forward for avasopasem and to progress the ongoing clinical trials for rucosopasem. Rucosopasem is the company’s second product candidate in development to augment the anti-cancer efficacy of stereotactic body radiation therapy for patients with non-small cell lung cancer and locally advanced pancreatic cancer.
Galera had 31 employees as of March 1, according to a regulatory filing. The company estimated Wednesday its balance of cash, cash equivalents and marketable securities as of June 30 was $38.8 million.
Write to Denny Jacob at [email protected]
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