Galectin Therapeutics stock plummets after FDA feedback on drug

Investing.com -- Galectin Therapeutics Inc (NASDAQ:GALT) stock plummets 33.6% in premarket trading Friday after the company received written feedback from the FDA regarding its belapectin development program instead of the requested in-person meeting.

The biopharmaceutical company, which focuses on developing galectin-3 targeted therapeutics for MASH cirrhosis patients, will now pursue a follow-up Type C meeting with the FDA to finalize remaining components of its next clinical trial design. While the company stated there is alignment with the agency on the proposed patient population for a registration trial, key aspects of the trial design remain unresolved.

Galectin Therapeutics indicated it views this next FDA interaction as an important step toward ensuring clarity as it advances belapectin toward a pivotal Phase 3 clinical trial. The company plans to present recently generated biomarker data at the follow-up meeting, including findings highlighted at last month’s American Association for the Study of Liver Diseases meeting.

"We appreciate the FDA’s written feedback and are encouraged by the agency’s evolving consideration of non-invasive tools and surrogate markers into clinical development for MASH cirrhosis," said Dr. Khurram Jamil, Chief Medical Officer at Galectin Therapeutics.

Separately, the company announced a new $10 million unsecured, convertible line of credit financing agreement provided by its chairman, Richard E. Uihlein. The maturity dates of all the company’s convertible lines of credit and convertible notes payable to its chairman have been extended through June 30, 2027, giving the company sufficient funding through at least March 2027.

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