08:08 AM EDT, 09/29/2025 (MT Newswires) -- Larimar Therapeutics ( LRMR ) said Monday that its ongoing long-term open label study evaluating daily subcutaneous injections of nomlabofusp in patients with Friedreich's ataxia showed consistent directional improvement across four key clinical outcomes.

The data provides support that nomlabofusp increases skin frataxin and that the strategy of skin frataxin replacement has the potential to result in a clinical benefit, the company said.

Anaphylaxis, or severe allergic reaction, has been reported in seven participants in the study, with most occurring on the initial day of administration and all occurring within the first six weeks of dosing, the company said. Excluding these events, long-term dosing of nomlabofusp was generally well tolerated, the company added.

The company said that process performance qualification on the commercial scale drug substance is planned in Q4, in preparation of data for its biologics license application submission.

The company's shares were down more than 36% in premarket activity on Monday.