---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-088704"
form_type: "8-K"
ticker: "LRMR"
cik: "0001374690"
company_name: "Larimar Therapeutics, Inc."
filed_at: "2025-06-23T23:59:59+00:00"
generated_at: "2026-05-18T23:26:52.877488+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Larimar gets FDA safety database guidance; nomlabofusp BLA submission planned for Q2 2026

## Summary
- FDA recommends safety database of ≥30 participants with 6-month continuous exposure (≥10 with 1-year), majority on 50 mg dose.
- BLA submission for accelerated approval now targeted for Q2 2026 to include recommended safety data.
- OLE data expected September 2025 from 30-40 participants, including those on the 50 mg dose.
- Adolescent PK run-in data also expected September 2025 from 14 participants (some placebo).
- FDA open to skin frataxin as reasonably likely surrogate endpoint; global Phase 3 study activities ongoing.

## SEC filing metadata
- accession: 0000950170-25-088704
- form_type: 8-K
- ticker: LRMR
- cik: 0001374690
- company_name: Larimar Therapeutics, Inc.
- filed_at: 2025-06-23T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1374690/000095017025088704/0000950170-25-088704-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1374690/000095017025088704/lrmr-20250623.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-088704
- JSON: https://secwatch.observer/filing/0000950170-25-088704.json
- Plain text: https://secwatch.observer/filing/0000950170-25-088704.txt

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