---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-23-006834"
form_type: "8-K"
ticker: "FULC"
cik: "0001680581"
company_name: "Fulcrum Therapeutics, Inc."
filed_at: "2023-03-09T23:59:59+00:00"
generated_at: "2026-06-18T07:10:18.634053+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA places FTX-6058 on clinical hold; Fulcrum reports Q4/FY2022 results

## Summary
- FDA placed full clinical hold on FTX-6058 IND for sickle cell disease; enrollment paused and dosing suspended.
- Phase 1b 12 mg cohort showed up to 10% absolute HbF increase; company working to address FDA concerns.
- Losmapimod Phase 3 REACH trial enrollment on track to complete in second half of 2023.
- Completed $117.3M public offering in January 2023; cash runway extends into mid-2025.
- CMO Santiago Arroyo resigned; Iain Fraser appointed Interim CMO, effective March 9, 2023.

## SEC filing metadata
- accession: 0000950170-23-006834
- form_type: 8-K
- ticker: FULC
- cik: 0001680581
- company_name: Fulcrum Therapeutics, Inc.
- filed_at: 2023-03-09T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1680581/000095017023006834/0000950170-23-006834-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1680581/000095017023006834/fulc-20230309.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-006834
- JSON: https://secwatch.observer/filing/0000950170-23-006834.json
- Plain text: https://secwatch.observer/filing/0000950170-23-006834.txt

## Key facts
- Earnings Releases
  Fulcrum Therapeutics, Inc. reported financial results for the quarter and year ended December 31, 2022.
  - Period: the quarter and year ended December 31, 2022
  - Result: reported results
  source text: On March 9, 2023, Fulcrum Therapeutics, Inc., or Fulcrum, announced its financial results for the quarter and year ended December 31, 2022.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1680581/000095017023006834/0000950170-23-006834-index.htm

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