Galera shares tank after US FDA declines to approve inflammation disease drug

Galera Therapeutics

09/08/2023 23:30

Aug 9 (Reuters) - Galera Therapeutics Inc  GRTX.O  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)
 ((Vaibhav.Sadhamta@thomsonreuters.com;))