(Reuters) – Galera Therapeutics Inc said the U.S. health regulator declined to approve its drug to treat radiotherapy-induced severe mouth inflammation in patients with advanced head and neck cancer undergoing standard-of-care treatment.
Shares of the drug developer tanked 82.6% after the bell on Wednesday.
The U.S. Food and Drug Administration (FDA), in a complete response letter, has requested for results from an additional trial for re-submission as it was not convinced with the experimental drug’s, avasopasem, effectiveness and safety in reducing severe oral mucositis.
Severe oral mucositis causes inflammation of mucus membranes in the mouth and throat, making it difficult for patients to eat and drink.
The company also announced a plan to initiate a restructuring, including reduction in its workforce by about 70%.
Galera said it would explore strategic alternatives, including partnerships, for the continued development of the experimental drug.
The company intends to request a meeting with the FDA to understand the regulator’s rationale for its decision and discuss next steps to support a re-submission seeking approval of avasopasem.
Galera now estimates that its cash, cash equivalents and marketable securities were $38.8 million as of June-end, and expects it to be sufficient to support operations into the second quarter of 2024.
(Reporting by Vaibhav Sadhamta, Khushi Mandowara and Pratik Jain in Bengaluru; Editing by Shilpi Majumdar)
