Recent 8-K filings for LRMR
Highest-materiality recent filing
Larimar plans rolling BLA for nomlabofusp in June 2026; Q1 net loss $29.6M
- Net loss Q1 2026 $29.6M ($0.31/sh) vs Q1 2025 $29.3M ($0.46/sh). Cash $200.4M.
- Intends to initiate rolling BLA seeking accelerated approval June 2026; CMC module H2 2026.
-
Larimar plans rolling BLA for nomlabofusp in June 2026; Q1 net loss $29.6M
Net loss Q1 2026 $29.6M ($0.31/sh) vs Q1 2025 $29.3M ($0.46/sh). Cash $200.4M.
-
Larimar reports Q4 net loss $62.5M; BLA for nomlabofusp on track for June 2026 submission
Net loss Q4 2025 $62.5M ($0.73/sh) vs $28.8M ($0.45/sh) in Q4 2024; R&D expenses rose to $59.4M.
-
Offering of 20,000,000 shares plus 3,000,000 over-allotment shares at $5.00 per share.
-
FDA granted Breakthrough Therapy Designation for nomlabofusp for adults and children with Friedreich's ataxia.
-
Larimar Therapeutics Q3 2025: Net loss $47.7M, nomlabofusp shows 100% FXN level in OL study
Net loss for Q3 2025 was $47.7M ($0.61 per share) vs $15.5M in Q3 2024, with R&D expenses up to $44.9M.
-
Larimar reports positive nomlabofusp data; all 6-month patients reach carrier-level FXN
10/10 participants at 6 months achieved skin FXN >50% of healthy volunteer median (asymptomatic carrier levels).
-
Larimar Therapeutics reports Q2 2025 net loss $26.2M; BLA for nomlabofusp on track for Q2 2026
Net loss $26.2M ($0.41/share) vs $21.6M ($0.34) in Q2 2024; R&D expenses $23.4M, up from $19.7M.
-
Larimar Therapeutics prices $64.4M common stock offering at $3.20 per share
Offering of 18,750,000 shares of common stock at $3.20; underwriters' over-allotment of 2,812,500 shares exercised in full.
-
Larimar gets FDA safety database guidance; nomlabofusp BLA submission planned for Q2 2026
FDA recommends safety database of ≥30 participants with 6-month continuous exposure (≥10 with 1-year), majority on 50 mg dose.
-
Larimar Q1 net loss $29.3M; FDA open to accelerated approval using skin FXN as surrogate endpoint
Net loss $29.3M ($0.46 per share) vs $14.7M ($0.27) YoY; R&D spend rose to $26.6M on manufacturing and Phase 3 prep.
-
Larimar reports FDA open to FXN as surrogate endpoint; BLA submission on track for end-2025
FDA considers skin FXN concentration reasonably likely surrogate endpoint for accelerated approval of nomlabofusp in Friedreich's ataxia.
-
Mean change from baseline of 1.32 pg/μg in buccal cells and 9.28 pg/μg in skin cells at Day 90.
-
Larimar reports Q3 2024 net loss of $15.5M; cash $203.7M, BLA target 2H 2025
Net loss of $15.5M ($0.24 per share) vs $9.1M loss ($0.21 per share) in Q3 2023.
-
Larimar Q2 net loss $21.6M; cash $226.1M; OLE interim data Q4; FDA START program
Net loss $21.6M ($0.34/sh) vs $8.4M loss in Q2 2023; R&D spend $19.7M up from $5.9M on manufacturing.
-
FDA removes partial clinical hold on Larimar's nomlabofusp for Friedreich's Ataxia
FDA cleared Phase 2 data review; nomlabofusp generally well-tolerated with dose-dependent frataxin increases.
-
Larimar Q1 net loss $14.7M; cash $239M; nomlabofusp Phase 2 positive; OLE dosed; BLA target 2H 2025
Net loss $14.7M ($0.27/shr) vs $6.5M in Q1 2023; R&D expenses rose to $12.9M on manufacturing and clinical costs.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.85 · Median 0.55 · Most common event other_material