secwatch.observer — SEC 8-K summary
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Issuer:     Larimar Therapeutics, Inc. (LRMR)
CIK:        0001374690
Form:       8-K
Filed at:   2025-06-23T23:59:59+00:00
Accession:  0000950170-25-088704
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1374690/000095017025088704/0000950170-25-088704-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1374690/000095017025088704/lrmr-20250623.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-088704

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