Galera Therapeutics Faces Setback in FDA Approval Process

Shares in Galera Therapeutics, a clinical-stage biopharmaceutical company, were halted from premarket trading on Tuesday. This action followed an announcement by the Food and Drug Administration (FDA) stating that the firm needs an additional Phase 3 trial for its treatment of radiotherapy-induced severe oral mucositis.

Stock Performance Takes a Hit

Galera's stock closed on Monday at 21 cents on the Nasdaq exchange, marking an 86% decline for the year thus far. This setback underscores the importance of obtaining FDA approval for the company's new drug application.

FDA Emphasizes the Need for Another Trial

Galera recently received the official meeting minutes from the FDA, in which the agency reiterated its requirement for an additional trial of avasopasem. This trial is deemed necessary to support the resubmission of Galera's new drug application. While disappointing, this feedback from the FDA serves as vital guidance for Galera's future endeavors.

Halting Trials to Evaluate Strategic Alternatives

In response to the FDA's requirements, Galera has decided to halt two important trials. Firstly, a Phase 2b trial of rucosopasem manganese, intended to treat locally advanced pancreatic cancer, has been put on hold. Additionally, a Phase 1/2 trial of the same drug for treating nonsmall cell lung cancer has been paused.

While this decision is regrettable, it allows Galera to conserve valuable financial resources. The company can now redirect its efforts towards assessing potential strategic alternatives in light of the recent setback.