Larimar Therapeutics, Inc., a clinical-stage biotechnology company, focuses on developing treatments for rare diseases. The company's lead product candidate is CTI-1601, which is in Phase 1 clinical trial for the treatment of Friedreich's ataxia, a rare and progressive genetic disease. Larimar Therapeutics, Inc. is headquartered in Bala Cynwyd, Pennsylvania.
IPO Year: 2014
Exchange: NASDAQ
Website: larimartx.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 10/16/2024 | $26.00 | Outperform | Oppenheimer |
| 10/3/2024 | $22.00 | Outperform | Wedbush |
| 10/2/2024 | $15.00 | Buy | H.C. Wainwright |
| 9/4/2024 | $16.00 | Outperform | Robert W. Baird |
| 4/3/2024 | $25.00 | Outperform | Leerink Partners |
| 11/17/2023 | $4.50 | Neutral → Buy | Citigroup |
| 10/19/2022 | $12.00 | Buy | Guggenheim |
| 2/15/2022 | Outperform → Market Perform | William Blair |
8-K - Larimar Therapeutics, Inc. (0001374690) (Filer)
SCHEDULE 13G/A - Larimar Therapeutics, Inc. (0001374690) (Subject)
8-K - Larimar Therapeutics, Inc. (0001374690) (Filer)
8-K - Larimar Therapeutics, Inc. (0001374690) (Filer)
10-Q - Larimar Therapeutics, Inc. (0001374690) (Filer)
8-K - Larimar Therapeutics, Inc. (0001374690) (Filer)
10-Q - Larimar Therapeutics, Inc. (0001374690) (Filer)
8-K - Larimar Therapeutics, Inc. (0001374690) (Filer)
8-K - Larimar Therapeutics, Inc. (0001374690) (Filer)
8-K - Larimar Therapeutics, Inc. (0001374690) (Filer)
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
Open label extension (OLE) study is progressing with all 7 sites activated; interim data planned for Q4 2024Selected 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 biomarkers for potential use in clinical trialsPlanning initiation of pharmacokinetic (PK) run-in study in adolescents by year-end 2024; plan to transition adolescents into ongoing OLE study upon completion of PK studyPlanning initiation of global confirmatory study by mid-2025
START is a new milestone-driven program designed to accelerate development of novel therapies intended to address an unmet medical need for rare diseasesNomlabofusp was selected based on potential for clinical benefit in a rare neurodegenerative disease and demonstrated development program readinessSTART pilot program is intended to improve development efficiency through enhanced communication with the FDANomlabofusp is expected to be one of three CDER programs and one of six total programs selected by the FDABLA submission continues to be targeted for 2H 2025 BALA CYNWYD, Pa., May 30, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (NASDAQ:LRMR), a clinical-stage biotechnol
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 doseInterim data from OLE study remains on track for Q4 2024Biologics License Application (BLA) submission targeted for 2H 2025 BALA CYNWYD, Pa., May 20, 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 U.S. FDA has removed the partial cl
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 potentialBiologics License Application ("BLA") submission targeted for 2H 2025; discussions initiated with Food and Drug Administration ("FDA") on potential to pursue accelerated approval pathwaySuccessful $161.8 million financing strengthens cash, cash equivalents, and marketable securities to $239 million as of March 31, 2024, extending projected cash runway into 2026 BALA
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 observedInitiated 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 2025In January 2024, initiated open label extension (OLE) study with 25 mg daily dosing of nomlabofusp, with first patient dosed in March 2024; interim data expected in Q4 2024 Recent successful financing that raised $161.6 million extends expected operating runway into 2026.
4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)
4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)
4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)
4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)
SC 13G/A - Larimar Therapeutics, Inc. (0001374690) (Subject)
SC 13G/A - Larimar Therapeutics, Inc. (0001374690) (Subject)
SC 13G/A - Larimar Therapeutics, Inc. (0001374690) (Subject)
SC 13G - Larimar Therapeutics, Inc. (0001374690) (Subject)
SC 13D/A - Larimar Therapeutics, Inc. (0001374690) (Subject)
SC 13G - Larimar Therapeutics, Inc. (0001374690) (Subject)
SC 13D/A - Larimar Therapeutics, Inc. (0001374690) (Subject)
SC 13D/A - Larimar Therapeutics, Inc. (0001374690) (Subject)
SC 13G - Larimar Therapeutics, Inc. (0001374690) (Subject)
SC 13G/A - Larimar Therapeutics, Inc. (0001374690) (Subject)
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)
Oppenheimer initiated coverage of Larimar Therapeutics with a rating of Outperform and set a new price target of $26.00
Wedbush initiated coverage of Larimar Therapeutics with a rating of Outperform and set a new price target of $22.00
H.C. Wainwright initiated coverage of Larimar Therapeutics with a rating of Buy and set a new price target of $15.00
Robert W. Baird initiated coverage of Larimar Therapeutics with a rating of Outperform and set a new price target of $16.00
Leerink Partners initiated coverage of Larimar Therapeutics with a rating of Outperform and set a new price target of $25.00
Citigroup upgraded Larimar Therapeutics from Neutral to Buy and set a new price target of $4.50
Guggenheim initiated coverage of Larimar Therapeutics with a rating of Buy and set a new price target of $12.00
William Blair downgraded Larimar Therapeutics from Outperform to Market Perform
JMP Securities initiated coverage of Larimar Therapeutics with a rating of Outperform
JMP Securities initiated coverage of Larimar Therapeutics with a rating of Mkt Outperform
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 Therapeutics Public Limited Company, has over 20 years of executive experience in regulatory and clinical strategy. "Dr. Sherman is a pharmaceutical industry veteran who brings decades of leadership experience in global regulatory and clinical strategy to our Board of Directors.
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 dataInitiation cleared for open-label extension (OLE) trial following FDA review of unblinded 25 mg cohort Phase 2 dataTop-line safety, pharmacokinetic, and frataxin data from the Phase 2 trial's 50 mg cohort expected in 1H 2024Initiation of OLE trial with 25 mg daily dosing expected in Q1 2024; interim data expected in Q4 2024 Cash, cash equivalents and marketable securities of $104.2 million as of June 30, 2023, provides projected cash runway into Q4 2024 BALA CYNWYD, Pa., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. ("Lari
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 the Company as needed. "We are delighted to welcome Dr. Clayton in his new role as CMO as we further expand our clinical development of CTI-1601. Rusty has been one of our closest advisors for the last 5 years, has attended every meeting between Larimar and the FDA, in
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 plannedLarimar 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 CompanyTop-line safety, pharmacokinetic, and pharmacodynamic (e.g., frataxin level) data from both of the Phase 2 trial's planned cohorts expected in 2H 2023 Cash and investments of $118.4 million at December 31, 2022 provides projected cash runway into 2H 2024 BALA CYNWYD, Pa., March 14, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeu
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 newly created position of Chief Development Officer (CDO). Dr. Shankar will report directly to Chief Executive Officer Carole Ben-Maimon, MD, and will be responsible for the strategic development of the Company's clinical and R&D programs, including additional applicati
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