Galera shares tank after US FDA declines to approve inflammation disease
drug
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[August 10, 2023]
(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.
![](http://archives.lincolndailynews.com/2023/Aug/10/images/ads/current/graue_sda_042021.png)
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%.
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![](http://archives.lincolndailynews.com/2023/Aug/10/images/ads/current/businessdirectory_dailycover_2023.png) 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)
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