---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-23-034217"
form_type: "8-K"
ticker: "LRMR"
cik: "0001374690"
company_name: "Larimar Therapeutics, Inc."
filed_at: "2023-07-25T23:59:59+00:00"
generated_at: "2026-06-13T02:59:10.925980+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA clears Larimar's Phase 2 CTI-1601 trial to proceed to 50 mg cohort and OLE trial

## Summary
- FDA cleared Phase 2 dose exploration trial to proceed to 50 mg cohort; dosed daily for 14 days then every other day to day 28.
- FDA also cleared initiation of open label extension (OLE) trial with 25 mg daily CTI-1601; enrollment expected Q1 2024, interim data Q4 2024.
- Top-line safety, PK, and frataxin data from the 50 mg cohort expected in first half of 2024.
- Clearance follows FDA review of unblinded data from completed 25 mg cohort (n=13) showing frataxin increases vs placebo.
- Further dose escalation and additional U.S. trials remain under partial clinical hold pending FDA review of 50 mg cohort results.

## SEC filing metadata
- accession: 0000950170-23-034217
- form_type: 8-K
- ticker: LRMR
- cik: 0001374690
- company_name: Larimar Therapeutics, Inc.
- filed_at: 2023-07-25T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1374690/000095017023034217/0000950170-23-034217-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1374690/000095017023034217/lrmr-20230725.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-034217
- JSON: https://secwatch.observer/filing/0000950170-23-034217.json
- Plain text: https://secwatch.observer/filing/0000950170-23-034217.txt

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