Galera Shares Halted After FDA Says Avasopasem Needs Additional Phase 3 Trial
October 31 2023 - 8:09AM
Dow Jones News
Adriano Marchese
Shares in Galera Therapeutics were halted from premarket trading
on Tuesday after the Food and Drug Administration said the company
needs an additional Phase 3 trial for its treatment
radiotherapy-induced severe oral mucositis.
The stock closed Monday at 21 cents on the Nasdaq exchange, down
about 86% for the year to date.
The clinical-stage biopharmaceutical company said it received
the official FDA meeting minutes in which the agency reiterated the
need for another trial of avasopasem to support the resubmission of
Galera's new drug application.
Galera also decided to halt a Phase 2b trial of rucosopasem
manganese, which aimed to treat locally advanced pancreatic cancer,
as well as a Phase 1/2 trial of the same drug to treat nonsmall
cell lung cancer.
Galera said this decision will allow it to better conserve cash
while it continues to assess potential strategic alternatives.
Write to Adriano Marchese at adriano.marchese@wsj.com
(END) Dow Jones Newswires
October 31, 2023 07:54 ET (11:54 GMT)
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