---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-043487"
form_type: "8-K"
ticker: "LRMR"
cik: "0001374690"
company_name: "Larimar Therapeutics, Inc."
filed_at: "2025-03-24T23:59:59+00:00"
generated_at: "2026-05-24T06:23:32.754143+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Larimar reports FDA open to FXN as surrogate endpoint; BLA submission on track for end-2025

## Summary
- FDA considers skin FXN concentration reasonably likely surrogate endpoint for accelerated approval of nomlabofusp in Friedreich's ataxia.
- BLA submission for accelerated approval targeted by year-end 2025; global Phase 3 study to initiate mid-2025.
- Net loss of $28.8M in Q4 2024 ($0.45/share) vs. $13.0M ($0.30/share) in Q4 2023; R&D expenses rose to $26.7M.
- Cash and equivalents $183.5M as of Dec 31, 2024; projected runway into Q2 2026.
- OLE study amended to include premedication after anaphylaxis deemed adverse drug reaction; 50 mg data expected Sept 2025.

## SEC filing metadata
- accession: 0000950170-25-043487
- form_type: 8-K
- ticker: LRMR
- cik: 0001374690
- company_name: Larimar Therapeutics, Inc.
- filed_at: 2025-03-24T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1374690/000095017025043487/0000950170-25-043487-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1374690/000095017025043487/lrmr-20250324.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-043487
- JSON: https://secwatch.observer/filing/0000950170-25-043487.json
- Plain text: https://secwatch.observer/filing/0000950170-25-043487.txt

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