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 accelerated approval pathway and acknowledged submitted data appear sufficient to support relationship between increased skin FXN... Read More

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 in 1x1 investor meetings at the Leerink Partners Global Healthcare Conference, taking place in Miami Beach, FL from March 10 – 12,... Read More

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 and plans to initiate a cohort of children 2-11 years old in 1H 2025 Long-term 50 mg data from adults in OLE study and available... Read More

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 Tissue FXN levels increased and were maintained over time, with mean levels increasing from 15% of healthy volunteers (HV) at... Read More

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 levels that are ≥50% of levels observed in healthy controls and similar to mean FXN levels reported in asymptomatic heterozygous... Read More

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 (OLE) study Initiation of PK run-in study in adolescents on track by year-end 2024 Initiation of global confirmatory/registration... Read More

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 exploration study, some of which has been previously disclosed, will be presented at the annual International Congress for Ataxia... Read More

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 investor meetings at the Wells Fargo Healthcare Conference, taking place September 4-6, 2024 in Boston, MA and the H.C. Wainwright 26th... Read More

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 Neuroimaging Consortium as an industry partner; TRACK-FA collects natural history data to establish disease-specific neuroimaging... Read More

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 readiness START pilot program is intended to improve development efficiency through enhanced communication with the FDA Nomlabofusp is... Read More

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) at the 25 mg dose Interim data from OLE study remains on track for Q4 2024 Biologics License Application (BLA) submission... Read More

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, reinforcing therapeutic potential Biologics License Application (“BLA”) submission targeted for 2H 2025; discussions initiated with... Read More

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 surrogate endpoint to support a Biologics License Application (“BLA”) submission for accelerated approval targeted for 2H 2025... Read More

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 approval targeted for H2 2025 Initial data expected in Q4 2024 BALA CYNWYD, Pa., March 11, 2024 (GLOBE NEWSWIRE) -- Larimar... Read More

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 in 1x1 investor meetings at the Leerink Partners Global Biopharma Conference, taking place in Miami Beach, FL from March 11 – 13,... Read More

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 19,736,842 shares of its common stock, which includes the exercise in full of the underwriters’ option to purchase 2,574,370... Read More

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 17,162,472 shares of its common stock at a price to the public of $8.74 per share, the closing price of its common stock on February... Read More

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 common stock and, in lieu of shares of common stock to certain investors that so choose, pre-funded warrants to purchase shares of... Read More

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 dose 25 mg daily of nomlabofusp with dosing anticipated to be starting later this quarter; Initial data expected in Q4 2024... Read More

Completed full enrollment and dosing of the 50 mg cohort in Phase 2 Friedreich's ataxia (FA) dose exploration trial; based on blinded observations during the dosing period, there were no serious adverse events in either the CTI-1601 (nomlabofusp) or placebo groups. Top-line safety, pharmacokinetic, and frataxin data from the Phase 2 trial now expected in Q1 2024, refined from H1 2024 Initiation of open label extension (OLE)... Read More

BALA CYNWYD, Pa., Nov. 01, 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 members of the company’s management team will participate in a fireside chat and 1x1 investor meetings at the Guggenheim 5 th Annual Inflammation, Neurology & Immunology Conference, taking place in New... Read More

BALA CYNWYD, Pa., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the appointment of Jeffrey W. Sherman, M.D., F.A.C.P. to the Company’s Board of Directors, effective today. Dr. Sherman, currently Executive Vice President, Chief Medical Officer (CMO) at Horizon... Read More

BALA CYNWYD, Pa., Aug. 31, 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 company management will participate in a panel discussion and 1x1 investor meetings at the Citi 18 th Annual BioPharma Conference, taking place in Boston, MA from September 5 - 7, 2023. Details on the... Read More

Initiation cleared for 50 mg cohort in Phase 2 Friedreich's ataxia (FA) dose exploration trial following FDA review of unblinded 25 mg cohort Phase 2 data Initiation cleared for open-label extension (OLE) trial following FDA review of unblinded 25 mg cohort Phase 2 data Top-line safety, pharmacokinetic, and frataxin data from the Phase 2 trial’s 50 mg cohort expected in 1H 2024 Initiation of OLE trial with 25 mg daily dosing... Read More

Top-line safety, pharmacokinetic, and pharmacodynamic (frataxin level) data from Phase 2 trial’s 50 mg cohort expected in 1H 2024 Initiation of open label extension trial with 25 mg daily dosing expected in Q1 2024; interim data expected in Q4 2024 Company 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:... Read More

BALA CYNWYD, Pa., July 17, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the appointment of Russell “Rusty” Clayton, DO, as Chief Medical Officer (“CMO”), effective today. Dr. Clayton succeeds former CMO Nancy M. Ruiz, MD, who is retiring and will provide consulting support to... Read More

BALA CYNWYD, Pa., June 21, 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 it is set to join the broad-market Russell 3000 Index at the conclusion of the 2023 Russell indexes annual reconstitution, effective after the U.S. market opens on June 26, 2023, according to a... Read More

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 28 Daily 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... Read More

BALA CYNWYD, Pa., March 28, 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 company management will participate in a virtual fireside chat and 1x1 investor meetings at the Guggenheim Genomic Medicines and Rare Disease Days, which are taking place from April 3 – 4, 2023.... Read More

First cohort of Larimar’s Phase 2 dose exploration trial of CTI-1601 in participants with Friedreich’s ataxia (FA) is fully enrolled and proceeding as planned Larimar expects to provide an update on the next steps of the Phase 2 trial in Q2 2023, after the FDA and independent data monitoring committee review data from the first cohort and provide feedback to the Company Top-line safety, pharmacokinetic, and pharmacodynamic... Read More

Biologics expert and long-time veteran of Johnson & Johnson will be responsible for the strategic development of Larimar’s clinical and R&D programs BALA CYNWYD, Pa., Feb. 07, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the appointment of Gopi Shankar, PhD, MBA, FAAPS, to the... Read More