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 (LRMR) announced a Type C FDA meeting scheduled for early Q3 2022 to address the ongoing clinical hold on its CTI-1601 program. This meeting aims to resolve issues related to previous mortalities in a non-human primate study, which led to the hold. As of March 31, 2022, Larimar reported $62.6 million in cash, indicating a runway into Q3 2023. The company recorded a net loss of $8.9 million for Q1 2022, an improvement from $12.1 million in Q1 2021, while R&D expenses decreased from $9.0 million to $5.8 million.
Larimar Therapeutics (Nasdaq: LRMR) reported its full-year 2021 financial results, highlighting clinical progress in developing CTI-1601 for Friedreich’s ataxia. Positive Phase 1 trial data indicated dose-dependent increases in frataxin levels, showing that CTI-1601 is generally well tolerated. Despite these advancements, the FDA's clinical hold remains in effect, necessitating more data. For 2021, the company recorded a net loss of $50.6 million, or $2.95 per share, with R&D expenses rising to $38.4 million. Cash reserves stood at $70.1 million as of year-end 2021.
Larimar Therapeutics (Nasdaq: LRMR) announced that the FDA is maintaining its clinical hold on the CTI-1601 program, requiring additional data for resolution. The company is reassessing its study plans and aims to engage the FDA for guidance. Despite this setback, Larimar believes there is a path forward based on existing data from Phase 1 trials, which showed CTI-1601 was generally well tolerated. The company emphasizes its commitment to CTI-1601 and has a strong cash position to support operations through at least 2023 while managing burn rates under a cost reduction plan.
Larimar Therapeutics (Nasdaq: LRMR), a clinical-stage biotechnology company, announced management participation in virtual 1x1 investor meetings at the Piper Sandler 33rd Annual Healthcare Conference from November 29 to December 2, 2021. The company is focused on developing treatments for complex rare diseases, particularly its lead compound CTI-1601, which is undergoing a Phase 1 clinical program for Friedreich's ataxia. Larimar aims to leverage its intracellular delivery platform to create new fusion proteins for additional rare diseases.
Larimar Therapeutics (Nasdaq: LRMR), a clinical-stage biotechnology company, announced its participation in 1x1 investor meetings at the Guggenheim Virtual Neuro/Immunology Conference on November 15-16, 2021. The company focuses on developing treatments for complex rare diseases, with its lead compound CTI-1601 currently in a Phase 1 clinical program targeting Friedreich's ataxia. Larimar aims to utilize its intracellular delivery platform for other fusion proteins aimed at rare diseases characterized by deficiencies in intracellular bioactive compounds.
Larimar Therapeutics, Inc. (Nasdaq: LRMR) reported its third quarter and year-to-date results as of September 30, 2021. The company has a strong balance sheet with $78 million in cash and marketable securities. Despite a clinical hold on its CTI-1601 program by the FDA due to safety concerns, they have compelling Phase 1 data and are focused on addressing Friedreich’s ataxia. The net loss for Q3 2021 was $16.8 million ($0.92 per share), increasing from $10.3 million in Q3 2020. R&D expenses rose to $14 million from $6.9 million in Q3 2020, driven by higher clinical supply costs.
LARIMAR Therapeutics, Inc. (Nasdaq: LRMR) announced participation in 1x1 investor meetings at the SVB Leerink CybeRx Series event focused on neuromuscular and rare diseases, scheduled for September 22-23, 2021. Larimar is a clinical-stage biotech company dedicated to developing treatments for complex rare diseases, with its lead compound, CTI-1601, undergoing Phase 1 clinical trials as a potential treatment for Friedreich's ataxia. The company aims to leverage its innovative intracellular delivery platform for future therapies targeting additional rare diseases.
Larimar Therapeutics (Nasdaq: LRMR), a clinical-stage biotechnology company, announced that Carole Ben-Maimon, MD, will present at the Morgan Stanley 19th Annual Global Healthcare Conference from September 9-15, 2021. The event features 1x1 investor meetings and will include a fireside chat on September 9 at 5:00 PM ET. Larimar is focused on developing treatments for complex rare diseases, notably its lead compound CTI-1601 for Friedreich's ataxia, currently in Phase 1 clinical trials in the U.S.
BALA CYNWYD, Pa., Aug. 19, 2021 – Larimar Therapeutics, Inc. (Nasdaq: LRMR) announced that Dr. David Bettoun will present at the World Orphan Drug Congress USA 2021 on August 27. His presentation, titled 'Expanding Therapeutic Possibilities for Rare Diseases,' will showcase preclinical in vitro data on Larimar's proprietary protein replacement therapy platform. Larimar is focused on developing treatments for rare diseases, with its lead compound, CTI-1601, currently in Phase 1 trials for Friedreich's ataxia.
Larimar Therapeutics (LRMR) reported positive Phase 1 results for CTI-1601, demonstrating proof-of-concept in Friedreich’s ataxia patients. Subcutaneous doses (50 mg and 100 mg) achieved frataxin levels comparable to normal heterozygous carriers. Safety data revealed no serious adverse events. As of June 30, 2021, the company had $70.6 million in cash. A $20 million equity financing was closed on July 2, 2021. However, the FDA placed a clinical hold on the CTI-1601 program due to mortalities in a toxicology study, requiring further data for trial resumption.