LRMR - Earnings announcements

In 4 completed studies and the ongoing OL study, 65 participants received at least 1 dose of nomlabofusp, including 39 in the OL study, with 14 on treatment for at least 6 months and 8 for over 1 year in the OL studyIncreases in skin FXN levels with short- and long-term daily nomlabofusp; 10/10 participants with data at 6 months achieved skin FXN levels over 50% of median levels in healthy volunteers (which is similar to levels in asymptomatic carriers)Consistent directional improvement across 4 key clinical outcomes (mFARS, FARS-ADL, 9-HPT, MFIS) observed after 1 year of nomlabofusp treatment could suggest potential for clinical benefit relative to a worsening in a FACOMS natural history st

BALA CYNWYD, Pa., Sept. 28, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (NASDAQ: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that the Company will host a conference call and webcast to discuss updates for the Company's nomlabofusp clinical development program including data from the ongoing long-term open label study for the treatment of Friedreich's ataxia on Monday, September 29, 2025 at 8:00 am EDT. Conference Call and Webcast DetailsTo access the webcast on Monday, September 29, 2025 at 8:00 am EDT, please visit this link to the event. To participate by phone, please dial 1-877-407-9716 (do

Interactions with FDA over the past year have provided clear expectations for the path to submission of the nomlabofusp BLAWritten FDA recommendations for safety database include a total of at least 30 participants with continuous exposure for 6 months including a subset of at least 10 with 1-year; large majority of the exposure should be on the 50 mg dose BLA submission seeking accelerated approval planned in the second quarter of 2026 to allow for inclusion of the recommended safety data for adults and childrenOLE data expected in September 2025 from 30-40 participants who received at least one dose of nomlabofusp; data will include participants on the 50 mg doseAdolescent PK run-in data e

BALA CYNWYD, Pa., June 20, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (NASDAQ:LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that the Company will host a conference call and webcast to discuss regulatory updates for the Company's nomlabofusp clinical development program for the treatment of Friedreich's Ataxia on Monday, June 23, 2025 at 8:00 am EDT. Conference Call and Webcast DetailsTo access the webcast on Monday, June 23, 2025 at 8:00 am EDT, please visit this link to the event. To participate by phone, please dial 1-877-407-9716 (domestic) or 1-201-493-6779 (international) and refer to confe

Daily subcutaneous injections of 25 mg nomlabofusp in 14 participants were generally well tolerated for up to 260 days in the ongoing open label extension (OLE) studyTissue frataxin (FXN) levels showed mean change from baseline of 1.32 pg/μg in buccal cells and 9.28 pg/μg in skin cells at Day 90Tissue FXN levels increased and were maintained over time, with mean levels increasing from 15% of healthy volunteers (HV) at baseline to 30% in buccal cells and from 16% to 72% in skin cells at Day 90Early trends towards improvement in clinical outcomes were observed at Day 90, supporting the potential that nomlabofusp administration may result in a clinical benefit across a broad spectrum of patient

Nomlabofusp was generally well tolerated following repeated subcutaneous injections in patients in the 25 and 50 mg cohorts with no serious adverse eventsDose dependent increases in frataxin levels were observed in skin and buccal cells Open Label Extension (OLE) study initiated in January 2024 to dose 25 mg daily of nomlabofusp with dosing anticipated to be starting later this quarter; Initial data expected in Q4 2024Initiated discussions with the FDA on use of tissue frataxin levels as a novel surrogate endpoint to support a potential Biologics License Application ("BLA") submission for accelerated approval targeted for 2H 2025 Company management to host webcast and conference call today a

Top-line safety, pharmacokinetic, and pharmacodynamic (frataxin level) data from Phase 2 trial's 50 mg cohort expected in 1H 2024Initiation of open label extension trial with 25 mg daily dosing expected in Q1 2024; interim data expected in Q4 2024Company management hosting a webcast and conference call today at 8:00 a.m. ET BALA CYNWYD, Pa., July 25, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. ("Larimar") (NASDAQ:LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's four-week, placebo-controlled, Phase 2 dose exploration trial of CTI-1601 i

Safety data indicate that repeated subcutaneous injections of 25 mg CTI-1601 were generally well tolerated when administered daily for 14 days and then every-other-day thereafter until day 28Daily subcutaneous injections of 25 mg CTI-1601 for 14 days led to increases in frataxin levels from baseline compared to placebo in all evaluated tissues (skin and buccal cells)Median placebo-adjusted increases from baseline of 3.5 pg/µg and 0.9 pg/µg in frataxin levels observed in skin and buccal cells, respectively, with 14 days of daily dosing of CTI-1601Larimar has submitted data to FDA and will meet with the Agency to discuss next steps; update expected in Q3 2023 Company management to host webcast

Initiation of the Phase 2 trial is expected in Q4 2022, with top-line data expected in 2H 2023 Company management hosting webcast and conference call today at 8:30 a.m. ET BALA CYNWYD, Pa., Sept. 14, 2022 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. ("Larimar") (NASDAQ:LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the initiation of the 25 mg cohort of a Phase 2, four-week, placebo-controlled, dose exploration trial of CTI-1601 in Friedreich's ataxia (FA) patients. In a written communication to Larimar, the FDA indicated it was lift