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Larimar Therapeutics Inc (NASDAQ: LRMR) is a clinical-stage biotechnology company pioneering treatments for rare genetic disorders through its innovative cell-penetrating peptide platform. This page serves as your definitive source for verified updates on clinical developments, regulatory milestones, and scientific advancements.
Investors and researchers will find timely updates on key programs including CTI-1601 for Friedreich's ataxia, partnership announcements, and preclinical research breakthroughs. Our curated news collection provides essential context for understanding the company's progress in addressing complex intracellular protein deficiencies.
All content undergoes rigorous verification to ensure accuracy and relevance. You'll find press releases detailing clinical trial phases, peer-reviewed research insights, and strategic corporate updates – all organized chronologically for efficient tracking of the company's trajectory.
Bookmark this page for streamlined access to LRMR's latest developments in rare disease therapeutics. Return regularly to stay informed about critical updates that shape the company's position in the biopharmaceutical landscape.
Larimar Therapeutics reported Q1 2025 financial results with significant progress in their nomlabofusp clinical development program for Friedreich's Ataxia (FA). The FDA has shown openness to considering skin FXN concentration as a surrogate endpoint for accelerated approval, with a BLA submission planned for year-end 2025.
Key developments include completion of adolescent dosing in the PK run-in study, plans for a global Phase 3 study in mid-2025, and an upcoming program update in September 2025 featuring OLE study data. The company maintains a strong financial position with $157.5 million in cash and equivalents, providing runway into Q2 2026.
Financial highlights show a Q1 2025 net loss of $29.3 million ($0.46 per share), compared to $14.7 million in Q1 2024. R&D expenses increased to $26.6 million, while G&A expenses rose to $4.6 million. The company is advancing toward potential registration of the first disease-modifying therapy for FA patients.
Larimar Therapeutics (NASDAQ: LRMR) has reported significant progress in its nomlabofusp development program for Friedreich's ataxia (FA). The FDA has indicated openness to considering skin frataxin (FXN) concentration as a surrogate endpoint for accelerated approval, acknowledging data supporting the relationship between skin FXN and relevant tissues.
Key developments include:
- BLA submission targeted for year-end 2025
- Global Phase 3 study planned for mid-2025
- Open Label Extension study progressing with 50mg dose
- Pediatric PK run-in study advancing for adolescents
Financial highlights:
- Q4 2024 net loss of $28.8 million ($0.45 per share)
- Full year 2024 net loss of $80.6 million ($1.32 per share)
- Strong cash position of $183.5 million as of December 31, 2024
- Cash runway projected into Q2 2026
Larimar Therapeutics (Nasdaq: LRMR), a clinical-stage biotechnology company specializing in complex rare disease treatments, has announced its participation in the upcoming Leerink Partners Global Healthcare Conference in Miami Beach, FL.
The company's management team will deliver a presentation on Monday, March 10, 2025, from 3:40 to 4:10 PM EST and engage in one-on-one investor meetings throughout the conference, which runs from March 10-12, 2025. The presentation will be accessible via webcast, and a replay will remain available for 30 days on Larimar's website under the 'Events and Presentations' section.
Larimar Therapeutics (LRMR) has initiated dosing of adolescents aged 12-17 in its pediatric pharmacokinetic (PK) run-in study for nomlabofusp, a treatment for Friedreich's ataxia (FA). The study participants receive weight-based doses equivalent to the 50 mg adult dose and are randomized 2:1 to receive either nomlabofusp or placebo daily for seven days.
Adolescents who complete the PK run-in study will be eligible to participate in the ongoing open label extension (OLE) study. The company plans to initiate a second cohort for children aged 2-11 in the first half of 2025. Long-term 50 mg data from adults in the OLE study and available adolescent PK run-in data are expected by mid-2025.
The OLE study evaluates safety, tolerability, PK, and FXN levels in buccal and skin cells, along with exploratory pharmacodynamic markers and clinical outcome measures following long-term subcutaneous administration of nomlabofusp.
Larimar Therapeutics (LRMR) announced positive initial data from its ongoing open label extension (OLE) study of nomlabofusp for Friedreich's Ataxia. The study, involving 14 participants treated with 25mg daily subcutaneous injections for up to 260 days, showed promising results in increasing frataxin (FXN) levels. Tissue FXN levels increased from 15% to 30% in buccal cells and from 16% to 72% in skin cells at Day 90, with early trends showing clinical improvements.
The company has initiated dose escalation to 50mg in 6 participants and plans to expand to adolescents in early 2025. With $203.7 million cash on hand as of September 2024, providing runway into Q2 2026, Larimar aims to submit a Biologics License Application in 2H 2025 for potential accelerated approval.
Larimar Therapeutics presented data from Phase 1 and Phase 2 dose exploration studies of nomlabofusp for Friedreich's ataxia (FA) at ICAR 2024. The studies, involving 61 adults with FA, showed that daily 50mg nomlabofusp administration could achieve frataxin (FXN) levels similar to asymptomatic carriers. Treatment modified gene expression and lipid profiles, trending towards healthy control values. The company plans to expand studies to include children and adolescents, with a program update expected mid-December 2024. A Biologics License Application (BLA) submission is targeted for second half of 2025.
Larimar Therapeutics (LRMR) reported Q3 2024 financial results with a net loss of $15.5 million ($0.24 per share). The company maintains a strong balance sheet with $203.7 million in cash and equivalents, projecting runway into 2026. Their lead program, nomlabofusp for Friedreich's ataxia, continues advancement with key upcoming milestones including: a program update in mid-December 2024, initiation of PK run-in study in adolescents by year-end, planned global confirmatory study mid-2025, and targeted BLA submission in 2H 2025. The company recently received ILAP designation from MHRA to accelerate market access in the UK.
Larimar Therapeutics (Nasdaq: LRMR) announced three poster presentations at the upcoming International Congress for Ataxia Research (ICAR) in London, U.K., from November 12-15, 2024. The presentations will showcase data from the company's nomlabofusp Phase 1 studies and Phase 2 dose exploration study for Friedreich's ataxia treatment.
Nomlabofusp is a novel protein replacement therapy designed to deliver frataxin to mitochondria, addressing the root cause of Friedreich's ataxia. The presentations will cover:
- Effects of nomlabofusp on tissue frataxin levels, plasma lipid profiles, and gene expression
- Disease characteristics and tissue frataxin concentrations in adult patients
- Prediction of tissue frataxin levels with long-term nomlabofusp administration
Dr. Russell Clayton, Chief Medical Officer of Larimar, will give an oral presentation on November 14, 2024.
Larimar Therapeutics (Nasdaq: LRMR), a clinical-stage biotech company specializing in treatments for complex rare diseases, has announced its participation in two upcoming investor conferences. The company's management team will engage in one-on-one meetings with investors at:
- The Wells Fargo Healthcare Conference in Boston, MA (September 4-6, 2024)
- The H.C. Wainwright 26th Annual Global Investment Conference in New York, NY (September 9-11, 2024)
These conferences provide Larimar with opportunities to connect with potential investors and showcase their progress in developing innovative treatments for rare diseases.
Larimar Therapeutics (Nasdaq: LRMR) reported Q2 2024 financial results and operational updates for its nomlabofusp program. Key highlights include:
- All 7 sites activated for open label extension (OLE) study; interim data expected in Q4 2024
- Selected for FDA's START pilot program to accelerate rare disease therapeutics
- Joined TRACK-FA Neuroimaging Consortium as industry partner
- Planning PK run-in study in adolescents by year-end 2024
- Global confirmatory study planned for mid-2025
- BLA filing targeted for 2H 2025 for accelerated approval
- $226.1M cash runway into 2026
Q2 2024 financials: Net loss of $21.6M ($0.34/share) vs $8.4M ($0.19/share) in Q2 2023. R&D expenses increased to $19.7M from $5.9M, mainly due to higher manufacturing and clinical trial costs.
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