Larimar Therapeutics Shares Rise 15% Nomlabofusp Selected for FDA Program

By Chris Wack

Larimar Therapeutics shares were up 15% at $8.17 after the company said the Food and Drug Administration has selected nomlabofusp to participate in the Support for Clinical Trials Advancing Rare Disease Therapeutics pilot program.

Nomlabofusp is Larimar's novel protein replacement therapy designed to address the root cause of Friedreich's ataxia by delivering frataxin to mitochondria.

The FDA's START selection was based on demonstrated development program readiness, and provides a path to potential Biologics License Application submission.

The START pilot program was launched by the FDA in September 2023 to further accelerate the pace of development, with an initial selection of up to six novel drugs, three by the Center for Drug Evaluation and Research, and three by the Center for Biologics Evaluation and Research, intended to treat a rare disease or other serious condition with high unmet medical need through an enhanced mechanism for communication with the FDA.

Nomlabofusp is currently being evaluated in an ongoing open label extension study to assess the long-term safety and tolerability, pharmacokinetics, and frataxin levels in peripheral tissues in patients with FA. Interim data from the study is expected in the fourth quarter of 2024.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

05-31-24 1058ET