Larimar Completes BLA Submission for Nomlabofusp in Friedreich’s Ataxia

Larimar Therapeutics (LRMR) completed its rolling Biologics License Application submission to the U.S. Food and Drug Administration seeking accelerated approval of nomlabofusp for Friedreich’s ataxia.

The application is supported by data from an ongoing long-term open-label study and seeks to use increases in skin frataxin concentrations as a potential novel surrogate endpoint. Larimar is also enrolling patients in its global confirmatory Phase 3 FORWARD-FA study.

• The company expects a BLA submission acceptance decision in early 2027.
• Larimar listed a potential U.S. approval milestone for mid-2027 and is targeting a U.S. launch in the third quarter of 2027, if approved.
• Previously reported open-label data showed sustained increases in skin frataxin; all evaluable participants at one year reached levels within the range expected in asymptomatic heterozygous carriers.
• FORWARD-FA will evaluate daily subcutaneous nomlabofusp over 18 months in ambulatory participants ages 2 to 40 who are new to the drug.
• Nomlabofusp holds FDA Breakthrough Therapy, Fast Track, Rare Pediatric Disease and Orphan Drug designations for Friedreich’s ataxia.

$LRMR Insider Trading Activity

$LRMR insiders have traded $LRMR stock on the open market 1 times in the past 6 months. Of those trades, 1 have been purchases and 0 have been sales.

Here’s a breakdown of recent trading of $LRMR stock by insiders over the last 6 months:

• THOMAS EDWARD HAMILTON purchased 50,000 shares for an estimated $166,890

To track insider transactions, check out Investivoq's insider trading dashboard. You can access data on insider stock transactions through the Investivoq API insider transaction endpoint.

$LRMR Hedge Fund Activity

We have seen 85 institutional investors add shares of $LRMR stock to their portfolio, and 75 decrease their positions in their most recent quarter.

Here are some of the largest recent moves:

• DEERFIELD MANAGEMENT COMPANY, L.P. added 5,000,000 shares (+16.3%) to their portfolio in Q2 2026, for an estimated $15,250,000
• DEFILADE CAPITAL MANAGEMENT, L.P. added 3,670,135 shares (+inf%) to their portfolio in Q2 2026, for an estimated $11,193,911
• MILLENNIUM MANAGEMENT LLC removed 2,292,241 shares (-63.2%) from their portfolio in Q2 2026, for an estimated $6,991,335
• BLUE OWL CAPITAL HOLDINGS LP added 2,043,150 shares (+28.7%) to their portfolio in Q2 2026, for an estimated $6,231,607
• BLACKROCK, INC. added 1,925,835 shares (+51.3%) to their portfolio in Q2 2026, for an estimated $5,873,796
• AIGH CAPITAL MANAGEMENT LLC added 1,850,000 shares (+inf%) to their portfolio in Q3 2026, for an estimated $5,910,750
• AQR CAPITAL MANAGEMENT LLC added 1,553,897 shares (+190.1%) to their portfolio in Q2 2026, for an estimated $4,739,385

To track hedge funds' stock portfolios, check out Investivoq's institutional holdings dashboard. You can access data on hedge funds moves and 13F filings through the Investivoq API 13F endpoint.