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September 29, 2025
Larimar Therapeutics Announces Positive Data from Ongoing Long-term Open Label Study and Updates to Nomlabofusp Program for Friedreich’s Ataxia >
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 study Increases in skin FXN levels with short- and long-term daily nomlabofusp; 10/10
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September 28, 2025
Larimar Therapeutics Announces Conference Call on the Nomlabofusp Program for the Treatment of Friedreich’s Ataxia >
Conference call and webcast on Monday, September 29, 2025 at 8:00 am EDT 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
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August 14, 2025
Larimar Therapeutics Reports Second Quarter 2025 Financial Results >
Initial data from the 50 mg dose in the open label study and the adolescent PK run-in study planned for program update in September 2025 Adolescent participants from the PK run-in study and patients with FA who have not participated in prior nomlabofusp clinical studies are currently screening and
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July 31, 2025
Larimar Therapeutics Announces Closing of Underwritten Public Offering of Common Stock and Exercise in Full of the Underwriters’ Option to Purchase Additional Shares >
BALA CYNWYD, Pa. , July 31, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the closing of its previously announced underwritten public offering of
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July 30, 2025
Larimar Therapeutics Announces Pricing of Underwritten Public Offering >
BALA CYNWYD, Pa. , July 29, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the pricing of its previously announced underwritten public offering of
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July 29, 2025
Larimar Therapeutics Announces Proposed Underwritten Public Offering >
BALA CYNWYD, Pa. , July 29, 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 it has commenced an underwritten public offering of shares of its
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July 8, 2025
Larimar Therapeutics Publishes Nonclinical Data Supporting the Therapeutic Potential of Nomlabofusp in Patients with Friedreich’s Ataxia >
Nonclinical findings provide evidence of the mechanism of action of nomlabofusp and support the potential use of skin FXN concentrations as a novel surrogate endpoint for Larimar’s planned BLA submission in Q2 2026 seeking accelerated approval BALA CYNWYD, Pa.
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June 23, 2025
Larimar Therapeutics Announces FDA Recommendations on Safety Database, and Other Details of Nomlabofusp BLA Submission for Friedreich’s Ataxia Program >
Interactions with FDA over the past year have provided clear expectations for the path to submission of the nomlabofusp BLA Written 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
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June 20, 2025
Larimar Therapeutics Announces Regulatory Update Call on the Nomlabofusp Program for the Treatment of Friedreich’s Ataxia >
Conference call and webcast on Monday, June 23, 2025 at 8:00 am EDT 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
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April 30, 2025
Larimar Therapeutics Reports First Quarter 2025 Financial Results >
FDA stated as part of a START pilot program meeting that it is open to considering skin FXN concentration as a reasonably likely surrogate endpoint in support of an accelerated approval BLA seeking accelerated approval planned to be submitted by year-end 2025; global Phase 3 study planned to
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March 24, 2025
Larimar Therapeutics Provides Nomlabofusp Development Update and Reports Fourth Quarter and Full Year 2024 Financial Results >
FDA stated in written correspondence for a START pilot program meeting that it is open to considering skin FXN concentration as a reasonably likely surrogate endpoint in support of an accelerated approval FDA recommended measuring skin FXN concentrations to support evidence of effectiveness for
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March 3, 2025
Larimar Therapeutics to Present at the Leerink Partners Global Healthcare Conference >
BALA CYNWYD, Pa. , March 03, 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 members of the company’s management team will present and participate
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January 23, 2025
Larimar Therapeutics Announces Dosing of Adolescents in Nomlabofusp Pediatric Pharmacokinetic Run-In Study for Patients with Friedreich’s Ataxia >
Adolescents receive a weight-based dose equivalent to the 50 mg adult dose Adolescents 12-17 years old who complete participation in the pharmacokinetic (PK) run-in study will be eligible to screen in the ongoing open label extension (OLE) study Larimar is continuing to enroll adolescent patients
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December 16, 2024
Larimar Therapeutics Announces Positive Initial Data from Ongoing Long-term Open Label Extension Study & Progress Across Nomlabofusp Program for Friedreich’s Ataxia >
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) study Tissue 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 90
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November 18, 2024
Larimar Therapeutics Presents Additional Data from Phase 1 Studies and Phase 2 Dose Exploration Study Supporting the Nomlabofusp Clinical Program at ICAR 2024 >
Treatment with nomlabofusp modified gene expression and lipid profiles in addition to increasing frataxin (FXN) levels in study participants with Friedreich’s ataxia (FA) Modeling and simulation predict that, in most patients with FA, 50 mg of nomlabofusp administered daily is likely to achieve FXN
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October 30, 2024
Larimar Therapeutics Reports Third Quarter 2024 Operating and Financial Results >
Nomlabofusp program update expected mid-December to include available safety, pharmacokinetic (PK) and frataxin data, as well as available clinical outcomes observations from patients with Friedreich’s ataxia (FA) receiving 25 mg of nomlabofusp daily for 30-180 days in ongoing open label extension
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September 19, 2024
Larimar Therapeutics Announces Three Poster Presentations at the Upcoming International Congress for Ataxia Research >
BALA CYNWYD, Pa. , Sept. 19, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that data from the Company’s nomlabofusp Phase 1 studies and Phase 2 dose
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August 27, 2024
Larimar Therapeutics to Participate in Upcoming Investor Conferences >
BALA CYNWYD, Pa. , Aug. 27, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics , Inc. ( Larimar ) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that members of the company’s management team will participate in 1x1
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August 7, 2024
Larimar Therapeutics Reports Second Quarter 2024 Operating and Financial Results >
Open label extension (OLE) study is progressing with all 7 sites activated; interim data planned for Q4 2024 Selected by Food and Drug Administration (FDA) to participate in Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program for nomlabofusp Joined TRACK-FA
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May 30, 2024
Larimar Therapeutics Selected by FDA to Participate in START Pilot Program for Nomlabofusp in Friedreich’s Ataxia >
START is a new milestone-driven program designed to accelerate development of novel therapies intended to address an unmet medical need for rare diseases Nomlabofusp was selected based on potential for clinical benefit in a rare neurodegenerative disease and demonstrated development program
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May 20, 2024
Larimar Therapeutics Announces FDA has Removed Partial Clinical Hold for Nomlabofusp Program in Friedreich’s Ataxia >
Food and Drug Administration (FDA) removed partial clinical hold following review of Phase 2 dose exploration study data Ongoing open label extension (OLE) study initially evaluating 25 mg; Larimar plans to dose escalate to 50 mg following further characterization of frataxin pharmacodynamics (PD)
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May 9, 2024
Larimar Therapeutics Reports First Quarter 2024 Operating and Financial Results >
First patient dosed in open label extension (OLE) study with 25 mg daily dosing of nomlabofusp; interim data on track for Q4 2024 Positive top-line Phase 2 dose exploration study data demonstrated nomlabofusp was generally well-tolerated with dose-dependent increases in tissue frataxin levels,
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March 14, 2024
Larimar Therapeutics Reports Fourth Quarter and Full Year 2023 Operating and Financial Results and Provides Update on Nomlabofusp Development >
Positive top-line data from Phase 2 dose exploration study of nomlabofusp, which was generally well-tolerated, with dose-dependent increases in tissue frataxin levels observed Initiated discussions with the Food and Drug Administration (FDA) on the potential use of tissue frataxin levels as a novel
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March 11, 2024
Larimar Therapeutics Announces the Dosing of the First Patient in Long-term Open Label Extension Study for Nomlabofusp in Patients with Friedreich’s Ataxia >
Study will inform on long-term safety profile and tissue frataxin levels OLE initiated with 25 mg daily subcutaneous injections of nomlabofusp Frataxin data and safety data from the OLE study are intended to help support a potential Biologics License Application (“BLA”) submission for accelerated
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March 6, 2024
Larimar Therapeutics to Present at the Leerink Partners Global Biopharma Conference >
BALA CYNWYD, Pa. , March 06, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics , Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that members of the company’s management team will present and participate
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February 16, 2024
Larimar Therapeutics Announces Closing of Underwritten Public Offering of Common Stock and Exercise in Full of the Underwriters’ Option to Purchase Additional Shares >
BALA CYNWYD, Pa. , Feb. 16, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the closing of its previously announced underwritten public offering of
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February 14, 2024
Larimar Therapeutics Announces Pricing of Underwritten Public Offering of Common Stock >
BALA CYNWYD, Pa. , Feb. 14, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the pricing of its previously announced underwritten public offering of
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February 13, 2024
Larimar Therapeutics Announces Proposed Underwritten Public Offering >
BALA CYNWYD, Pa. , Feb. 13, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that it has commenced an underwritten public offering of shares of its
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February 12, 2024
Larimar Therapeutics Reports Positive Top-line Data from Phase 2 Dose Exploration Study from 25 mg and 50 mg Cohorts of Nomlabofusp in Patients with Friedreich’s Ataxia >
Nomlabofusp was generally well tolerated following repeated subcutaneous injections in patients in the 25 and 50 mg cohorts with no serious adverse events Dose dependent increases in frataxin levels were observed in skin and buccal cells Open Label Extension (OLE) study initiated in January 2024 to