Ready 8-Ks
50
Latest filing
August 4, 2026, 7:02 AM ET
Top materiality
0.85
Event mix
other_material ×23 · earnings ×10 · regulatory ×7
Sentiment
21 pos · 1 neg · 28 neu
Latest earnings
▼ miss 2025-Q3
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Larimar Q2 net loss $32.8M; nomlabofusp BLA rolling submission underway
Net loss $32.8M ($0.30/sh) vs $26.2M ($0.41/sh) in Q2 2025; cash $156.3M, runway into Q3 2027.
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Larimar submits BLA module for nomlabofusp accelerated approval; positive open-label data in Friedreich's ataxia
Submitted first module of rolling BLA to FDA for accelerated approval of nomlabofusp; FDA confirmed existing data appears sufficient.
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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.
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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.
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Larimar Therapeutics prices 20M share public offering at $5.00 per share; underwriters exercise over-allotment
Offering of 20,000,000 shares plus 3,000,000 over-allotment shares at $5.00 per share.
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Larimar Therapeutics receives FDA Breakthrough Therapy Designation for nomlabofusp in Friedreich's ataxia
FDA granted Breakthrough Therapy Designation for nomlabofusp for adults and children with Friedreich's ataxia.
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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.
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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).
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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.
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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.
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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.
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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.
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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.
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Larimar reports positive OLE data: FXN up to 30% of healthy in buccal cells at Day 90; BLA filing targeted 2H 2025
Mean change from baseline of 1.32 pg/μg in buccal cells and 9.28 pg/μg in skin cells at Day 90.
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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.
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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.
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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.
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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.
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Larimar reports positive Phase 2 data for nomlabofusp; $161.6M financing extends runway into 2026
Phase 2 dose exploration study met endpoints: dose-dependent frataxin increases in skin and buccal cells; 50 mg cohort saw levels >33% of healthy volunteers in all patients at Day 14.
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Larimar doses first patient in open-label extension study of nomlabofusp for Friedreich's ataxia
First patient dosed in OLE evaluating 25 mg daily subcutaneous nomlabofusp for Friedreich's ataxia.
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Larimar Therapeutics closes $161.8M public offering of 19.7M shares at $8.74
Offered 17,162,472 shares plus 2,574,370 option shares exercised immediately.
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Larimar reports positive Phase 2 nomlabofusp data; frataxin dose response up to 5.57 pg/µg in skin
50 mg cohort: median FXN increase in skin 5.57 pg/µg at day 14; all patients reached >33% healthy volunteer level.
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Larimar completes Phase 2 50mg cohort enrollment; top-line data now Q1 2024; cash to Q1 2025
Completed enrollment and dosing of 50 mg cohort in Phase 2 FA trial; no serious adverse events observed (blinded).
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Larimar Therapeutics Q2 net loss $8.4M; FDA clears 50 mg cohort and OLE trial for CTI-1601 in FA
Net loss of $8.4M (-$0.19/share) vs $8.7M in Q2 2022; cash $104.2M, runway into Q4 2024.
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FDA clears Larimar's Phase 2 CTI-1601 trial to proceed to 50 mg cohort and OLE trial
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.
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Larimar Phase 2 trial shows frataxin increases in skin and buccal cells; Q1 net loss $6.5M
Median placebo-adjusted frataxin increase from baseline: 3.5 pg/µg in skin, 0.9 pg/µg in buccal cells at day 14.