Galera Shares Halted After FDA Says Avasopasem Needs Additional Phase 3 Trial

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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