By Robb M. Stewart

Larimar Therapeutics' shares rallied ahead of the opening bell after the biotechnology company's lead compound received breakthrough therapy designation from the Food and Drug Administration.

In premarket trading, the shares were 29% higher at $3.63. The stock had been down so far in February, and had lost 23% over the last three months.

Larimar on Tuesday said nomlabofusp, a protein replacement therapy that is being developed as a potential treatment for Friedreich's ataxia, was granted the important designation that is designed to expedite the development and regulatory review of drugs targeting serious conditions.

The company said breakthrough therapy designation and FDA feedback on its submission were based on the regulator's review of available clinical data from an ongoing open label study evaluating nomlabofusp in adult and pediatric patients with Friedreich's ataxia.

Larimar is targeting a biologics license application submission in June, backed by topline open-label study data that is expected in the second quarter.

Write to Robb M. Stewart at robb.stewart@wsj.com

(END) Dow Jones Newswires

February 24, 2026 07:37 ET (12:37 GMT)

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