Why Is Greenwich Lifesciences (GLSI) Stock Up Today?

  • Greenwich Lifesciences (GLSI) stock is jumping on clinical trial news.
  • The U.S. Food and Drug Administration (FDA) is allowing it to resume a Phase III clinical trial.
  • This trial was on hold due to issues related to manufacturing.
colorful pills and vials sitting on a table representing GLSI Stock.

Source: Bukhta Yurii / Shutterstock.com

Greenwich Lifesciences (NASDAQ:GLSI) stock is heading higher on Tuesday after the U.S. Food and Drug Administration (FDA) lifted a hold on a Phase III clinical trial.

That hold from the FDA was keeping the biopharmaceutical company from advancing its Flamingo-01 Phase III clinical trial. This is a study focusing on GP2, which is “an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery.”

The clinical trial was put on hold after the FDA raised issues with the manufacturing and the pharmacy process of the drug. Greenwich Lifesciences notes that it has addressed the complaints raised by the FDA.

According to Greenwich Lifesciences, the FDA alerted it on July 11 that it can resume its Phase III clinical trial of GP2. The company has already started site initiation visits and plans to provide further updates in the future.

The update from the FDA has GLSI stock experiencing heavy trading on Tuesday. As of this writing, more than 4 million shares of the company’s stock have changed hands. That’s a massive jump compared to its daily average trading volume of about 149,000 shares.

GLSI stock is up 25.9% as of Tuesday morning. Even so, it is still down 54% since the start of the year.

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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.


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