SCHEDULE 13G - Larimar Therapeutics, Inc. (0001374690) (Subject)

SCHEDULE 13G/A - Larimar Therapeutics, Inc. (0001374690) (Subject)

8-K - Larimar Therapeutics, Inc. (0001374690) (Filer)

SCHEDULE 13G/A - Larimar Therapeutics, Inc. (0001374690) (Subject)

8-K - Larimar Therapeutics, Inc. (0001374690) (Filer)

10-Q - Larimar Therapeutics, Inc. (0001374690) (Filer)

8-K - Larimar Therapeutics, Inc. (0001374690) (Filer)

DEF 14A - Larimar Therapeutics, Inc. (0001374690) (Filer)

S-8 - Larimar Therapeutics, Inc. (0001374690) (Filer)

10-K - Larimar Therapeutics, Inc. (0001374690) (Filer)

4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)

4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)

4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)

4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)

4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)

4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)

4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)

4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)

4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)

4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)

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

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 initiate in mid-2025 Completed dosing in adolescent PK run-in study; topline 50 mg dose data from the OLE study and data from adolescent cohort planned for program update in September 2025 Strong balance sheet of $157.5 million cash, cash equivalents and marketable securities as of March 31, 2025, with projected cash runway into second quarter of 2026 BALA CYNWYD, Pa., April 30, 2025 (GLOBE NEWSWIRE

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 approvalFDA 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 concentrations and relevant tissues such as heart, dorsal root ganglia and skeletal muscleLarimar is continuing discussions with FDA on the adequacy of the safety data set to support BLA submission BLA seeking accelerated approval targeted for submission by year-end 2025FDA

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, 2025. Details on the presentation can be found below. Date: Monday, March 10, 2025Time: 3:40 – 4:10 PM ESTWebcast Link: https://wsw.com/webcast/leerink38/lrmr/2247553 Following the conclusion of the presentation, a replay will be available for 30 days on the "Events an

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 adolescent PK run-in data expected mid-2025 BALA CYNWYD, Pa., Jan. 23, 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 do

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

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 carriers Disease characteristics of adult participants in the nomlabofusp studies were representative of the broad population of adults with FARelationships between tissue FXN levels and onset of disease and GAA repeat length observed at baseline in nomlabofusp clinica

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) studyInitiation of PK run-in study in adolescents on track by year-end 2024Initiation of global confirmatory/registration study planned mid-2025Biologics License Application (BLA) submission for nomlabofusp targeted for 2H 2025 to support potential accelerated approvalStrong balance sheet of $203.7 million cash, cash equivalents and marketable securities as of September 30, 2024, with project

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 Research (ICAR) being held November 12-15, 2024 in London, U.K. Nomlabofusp is a novel protein replacement therapy designed to address the root cause of Friedreich's ataxia by delivering frataxin to mitochondria. Larimar will present three posters during the conference, on

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 Annual Global Investment Conference, taking place September 9-11, 2024 in New York, NY. About Larimar TherapeuticsLarimar Therapeutics, Inc. (NASDAQ:LRMR), is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases. Larimar's lead