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 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 announced that the FDA has selected its therapy, nomlabofusp, for the START pilot program. This program aims to accelerate the development of treatments for rare diseases. Nomlabofusp is a novel protein replacement therapy targeting the root cause of Friedreich’s ataxia (FA) by delivering frataxin to mitochondria.
The selection was based on the therapy's potential for clinical benefit and its development readiness. The START program facilitates enhanced communication with the FDA, which can speed up pivotal study initiation and the path to a Biologics License Application (BLA), currently targeted for the second half of 2025. Interim data from an ongoing open-label extension study is expected in Q4 2024.
Larimar's participation in START could improve development efficiency through more frequent interactions with the FDA, ensuring high-quality, reliable data to support future applications.
Larimar Therapeutics (Nasdaq: LRMR) announced that the FDA has removed the partial clinical hold on their nomlabofusp (CTI-1601) program, aimed at treating Friedreich’s Ataxia (FA). This decision followed the review of data from a recently completed Phase 2 dose exploration study, which included 25 mg and 50 mg cohorts. The study showed that nomlabofusp was well-tolerated and demonstrated dose-dependent increases in frataxin levels. Larimar plans to escalate the dose to 50 mg in the ongoing open-label extension (OLE) study. Interim data from this study is expected in Q4 2024, with a Biologics License Application (BLA) submission targeted for the second half of 2025.
Larimar Therapeutics reported positive Phase 2 data for nomlabofusp in treating Friedreich's ataxia, with dose-dependent increases in frataxin levels. BLA submission expected in 2025, with FDA discussions ongoing. A financing round raised $161.8 million, extending cash runway to 2026. First patient dosed in OLE study with interim data due in Q4 2024.
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