Larimar Therapeutics Shares Tumble Premarket as FDA Hold Continues

By Colin Kellaher

Shares of Larimar Therapeutics Inc. plummeted in premarket trading Tuesday after the clinical-stage biotechnology company said the U.S. Food and Drug Administration extended a clinical hold on CTI-1601, its lead compound.

The Bala Cynwyd, Pa., company said the agency is maintaining the hold, in place since May of last year, and is requesting additional data.

Larimar, which is working to develop CTI-1601 in the rare neuromuscular disease Friedreich's ataxia, said it is further analyzing previously completed studies and evaluating whether more studies are warranted.

The company said that it plans to discuss with the FDA how best to provide the data, adding that it still believes there is a path forward through the resolution of the clinical hold.

The company said it is also reassessing the timing of planned open-label extension and pediatric multiple-ascending dose studies as it works to meet the FDA's request.

Larimar shares, which closed Monday at $8.37, were recently down 58% to $3.55 in premarket trading.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

February 15, 2022 06:48 ET (11:48 GMT)

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