Business

Larimar Therapeutics Publishes Nonclinical Data Supporting the Therapeutic Potential of Nomlabofusp in Patients with Friedreich’s Ataxia

Nonclinical findings provide evidence of the mechanism of action of nomlabofusp and support the potential use of skin FXN concentrations as a novel surrogate endpoint for Larimar’s planned BLA submission in Q2 2026 seeking accelerated approval BALA CYNWYD, Pa., July 08, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the publication of two peer-reviewed

articleLarimar Therapeutics, Inc.July 8, 20255/company/larimar-therapeutics-inc/news/larimar-therapeutics-publishes-nonclinical-data-110000538
Larimar Therapeutics Publishes Nonclinical Data Supporting the Therapeutic Potential of Nomlabofusp in Patients with Friedreich’s Ataxia

About this update from Larimar Therapeutics, Inc.

[{"type":"image","alt":"Larimar Therapeutics","displaySize":"","headline":null,"caption":"Larimar Therapeutics","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":107,"url":"https://media.zenfs.com/en/globenewswire.com/59a0cb6afa06818e6bf352c70da11d95"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/1uUrf9fLQ_8GcyV6eEAsEw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE1MDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/59a0cb6afa06818e6bf352c70da11d95","width":300,"height":107}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"Nonclinical findings provide evidence of the mechanism of action of nomlabofusp and support the potential use of skin FXN concentrations as a novel surrogate endpoint for Larimar’s planned BLA submission in Q2 2026 seeking accelerated approval","length":243,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":243,"olType":false},{"type":"text","content":"BALA CYNWYD, Pa., July 08, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the publication of two peer-reviewed articles highlighting nonclinical data on the therapeutic potential, pharmacology, and mechanism of action of nomlabofusp as a novel frataxin (FXN) protein replacement therapy designed to address the underlying cause of Friedreich’s ataxia (FA). These data were included in the briefing package reviewed by the U.S. Food and Drug Administration (FDA) in support of potentially using skin FXN concentrations as a reasonably likely surrogate endpoint (RLSE) for Larimar’s registrational program seeking accelerated approval for nomlabofusp.","length":795,"tagName":"p"},{"type":"text","content":"The articles, now available online, are titled:","length":47,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"“Pharmacokinetics and Pharmacodynamics of Nomlabofusp in Non‑clinical Studies of Friedreich’s Ataxia” (link)","length":108,"tagName":"p"}]},{"val":[{"type":"text","content":"“Nomlabofusp, a Fusion Protein of Human Frataxin and a Cell Penetrant Peptide, Delivers Mature and Functional Frataxin into Mitochondria” (link)","length":144,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":252,"olType":false},{"type":"text","content":"“We are please...

More updates from Larimar Therapeutics, Inc.

Friedreich’s ataxiaForward-Looking Statementsrare diseasesFDALarimar Therapeutics, Inc.Larimarclinical Studies