LRMR Larimar

nomlabofusp · NCT06447025 registry update

countries: {'total_sites': 11, 'us_sites': 11} → {'total_sites': 10, 'us_sites': 10}

nomlabofusp · NCT06447025 registry update

countries: {'total_sites': 8, 'us_sites': 8} → {'total_sites': 11, 'us_sites': 11}

Larimar submits first module of rolling BLA for nomlabofusp

Larimar has initiated a rolling BLA submission seeking accelerated approval for nomlabofusp in Friedreich’s ataxia, with the first module already submitted and the full submission expected to be completed in the second half of 2026. FDA alignment was confirmed following a Type B pre-BLA meeting, including acceptance of the existing open-label data package and FXN as a novel surrogate endpoint. The company also expects to dose the first patient in its global confirmatory Phase 3 study in Q3 2026.

Larimar submits first module of rolling BLA for nomlabofusp in Friedreich’s ataxia

Larimar has initiated a rolling BLA submission for accelerated approval of nomlabofusp after FDA confirmed the existing data package appears sufficient for review. The first module was submitted; remaining modules are expected in 2H 2026. FDA reaffirmed willingness to consider skin FXN as a novel surrogate endpoint.

Larimar submits first module of rolling BLA for nomlabofusp in FA

Larimar has initiated a rolling BLA submission for accelerated approval of nomlabofusp in Friedreich’s ataxia after FDA confirmed the existing data package appears sufficient. The first module was submitted; remaining modules are expected in 2H 2026. FDA reaffirmed willingness to consider skin FXN as a novel surrogate endpoint.

Larimar receives Breakthrough Therapy Designation for nomlabofusp in FA

FDA granted Breakthrough Therapy Designation to nomlabofusp for adults and children with Friedreich’s ataxia based on open-label study data. The designation reflects FDA’s recognition of unmet need and the drug’s potential to address underlying FXN deficiency. It does not alter the planned BLA submission timeline or regulatory path.

Larimar: FDA grants Breakthrough Therapy Designation to nomlabofusp in FA

FDA granted Breakthrough Therapy Designation to nomlabofusp for FA based on open-label study data. FDA reaffirmed willingness to consider skin FXN as a surrogate endpoint for accelerated approval. Company remains on track for BLA submission in June 2026 seeking accelerated approval.

Larimar: nomlabofusp regulatory update expected Q1 2026; BLA Q2 2026

The deck states that a regulatory update and timeline confirmation are expected in Q1 2026. It also confirms the company is targeting a BLA submission for accelerated approval in Q2 2026, with a U.S. launch targeted for early 2027.

Larimar Therapeutics targets nomlabofusp BLA submission Q2 2026

The company updated its corporate deck to confirm it will pursue accelerated approval for nomlabofusp in Friedreich’s Ataxia based on sustained skin FXN increases. It continues to target BLA filing in Q2 2026 and has modified the starting dose regimen to mitigate anaphylaxis risk after FDA review of the full safety, FXN, and clinical data package.

Larimar Therapeutics targets nomlabofusp BLA submission in Q2 2026

The company announced a BLA submission seeking accelerated approval for nomlabofusp in Friedreich's ataxia is targeted for the second quarter of 2026. A modified starting-dose regimen to mitigate anaphylaxis risk has been agreed with the FDA and is being incorporated into the Phase 3 protocol. The company also plans a regulatory and open-label study update in the first quarter of 2026.

Larimar Therapeutics plans nomlabofusp BLA filing Q2 2026 for Friedreich’s Ataxia

The company updated its corporate deck with new open-label data showing sustained FXN increases and directional clinical improvements, and reaffirmed its plan to submit a BLA in Q2 2026 seeking accelerated approval based on skin FXN levels. The FDA has agreed with the revised dosing regimen after anaphylaxis cases.

LRMR: nomlabofusp BLA for Friedreich’s ataxia targeted Q2 2026

Larimar announced positive long-term open-label data showing sustained FXN increases and directional clinical improvements, and stated that a BLA seeking accelerated approval is now targeted for Q2 2026. The company also reported a new starting-dose regimen agreed with FDA to mitigate anaphylaxis risk.