secwatch.observer — SEC 8-K summary
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Issuer:     Larimar Therapeutics, Inc. (LRMR)
CIK:        0001374690
Form:       8-K
Filed at:   2024-12-16T23:59:59+00:00
Accession:  0000950170-24-136384
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Larimar reports positive OLE data: FXN up to 30% of healthy in buccal cells at Day 90; BLA filing targeted 2H 2025
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- Mean change from baseline of 1.32 pg/μg in buccal cells and 9.28 pg/μg in skin cells at Day 90.
- Tissue FXN increased from 15% to 30% of healthy volunteers in buccal cells and 16% to 72% in skin cells.
- Daily 25 mg nomlabofusp generally well tolerated; two SAEs resolved within 24 hours; 50 mg dose escalation initiated.
- BLA submission for potential accelerated approval targeted for 2H 2025; cash runway of $203.7M into Q2 2026.
- Early trends towards improvement in mFARS, ADL, and other clinical outcomes observed at Day 90.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1374690/000095017024136384/0000950170-24-136384-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1374690/000095017024136384/lrmr-20241216.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-136384

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer