secwatch.observer — SEC 8-K summary
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Issuer:     Larimar Therapeutics, Inc. (LRMR)
CIK:        0001374690
Form:       8-K
Filed at:   2023-07-25T23:59:59+00:00
Accession:  0000950170-23-034217
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1374690/000095017023034217/0000950170-23-034217-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1374690/000095017023034217/lrmr-20230725.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-034217

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