---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-286780"
form_type: "8-K"
ticker: "LRMR"
cik: "0001374690"
company_name: "Larimar Therapeutics, Inc."
filed_at: "2026-06-29T10:33:36+00:00"
generated_at: "2026-06-29T10:35:19.501667+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Larimar submits BLA module for nomlabofusp accelerated approval; positive open-label data in Friedreich's ataxia

## Summary
- Submitted first module of rolling BLA to FDA for accelerated approval of nomlabofusp; FDA confirmed existing data appears sufficient.
- Open-label study: 100% (9/9) of participants achieved skin FXN levels >50% of healthy volunteer mean at 1 year.
- Clinical outcomes improved vs natural history: mean 1.0-point mFARS improvement vs 1.6-point worsening at 1 year.
- Safety: anaphylaxis in 10/43 patients; 9 had prior nomlabofusp exposure, 1 no prior; all recovered.
- First patient in confirmatory Phase 3 expected Q3 2026; targeting mid-2027 launch if approved.

## SEC filing metadata
- accession: 0001193125-26-286780
- form_type: 8-K
- ticker: LRMR
- cik: 0001374690
- company_name: Larimar Therapeutics, Inc.
- filed_at: 2026-06-29T10:33:36+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1374690/000119312526286780/0001193125-26-286780-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1374690/000119312526286780/lrmr-20260629.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-286780
- JSON: https://secwatch.observer/filing/0001193125-26-286780.json
- Plain text: https://secwatch.observer/filing/0001193125-26-286780.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.