Welcome to our dedicated page for Larimar Therapeutics news (Ticker: LRMR), a resource for investors and traders seeking the latest updates and insights on Larimar Therapeutics stock.
Larimar Therapeutics, Inc. (NASDAQ: LRMR) is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, with its lead compound, nomlabofusp, in development as a potential treatment for Friedreich’s ataxia (FA). The Larimar news feed on Stock Titan aggregates the company’s press releases and related coverage so readers can follow key milestones in this rare disease program.
News about Larimar frequently centers on clinical data updates from the ongoing long-term open-label and open-label extension studies of nomlabofusp in FA. The company has reported increases in skin frataxin (FXN) levels with daily subcutaneous dosing, directional improvements in clinical outcome measures such as mFARS, FARS-ADL, 9-Hole Peg Test, and Modified Fatigue Impact Scale, and long-term safety observations including injection site reactions and anaphylaxis events. Larimar also publishes nonclinical findings that describe the mechanism of action and pharmacology of nomlabofusp as an FXN protein replacement therapy.
Another major category of LRMR news involves regulatory interactions and timelines. Larimar has disclosed written recommendations from the U.S. Food and Drug Administration on the safety database needed for its Biologics License Application and the agency’s openness to using skin FXN concentrations as a reasonably likely surrogate endpoint for an accelerated approval pathway. The company regularly issues press releases on these regulatory updates, its participation in the START pilot program, and its targeted timing for a BLA submission seeking accelerated approval.
Investors and followers will also see financial results and capital markets announcements, including quarterly operating and financial updates, underwritten public offerings of common stock, and the use of proceeds to fund nomlabofusp development and other pipeline plans. For a consolidated view of LRMR-related developments—spanning clinical, regulatory, and financing events—this news page provides an organized stream of Larimar’s own disclosures and market-facing communications.
Larimar Therapeutics (NASDAQ: LRMR), a clinical-stage biotech company, has announced a proposed underwritten public offering of its common stock and pre-funded warrants. The offering includes a 30-day option for underwriters to purchase up to an additional 15% of securities at the public offering price.
The company plans to use the proceeds to support the development of nomlabofusp and other pipeline candidates, along with working capital and general corporate purposes. Leerink Partners and Guggenheim Securities are serving as joint bookrunning managers for the offering, which will be made under an effective S-3 shelf registration.
Larimar Therapeutics (NASDAQ:LRMR) has published two peer-reviewed articles highlighting nonclinical data supporting nomlabofusp as a potential treatment for Friedreich's ataxia (FA). The research demonstrates the drug's mechanism of action and its ability to increase frataxin (FXN) protein levels in key tissues.
The data was included in the FDA briefing package supporting the use of skin FXN concentrations as a reasonably likely surrogate endpoint for accelerated approval. Larimar plans to submit a Biologics License Application (BLA) in Q2 2026, positioning nomlabofusp as the first potential disease-modifying therapy for FA patients.
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.