Amendment: SEC Form SC 13G/A filed by Larimar Therapeutics Inc.
$LRMR
Biotechnology: Pharmaceutical Preparations
Health Care
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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 1/29/2025 | $18.00 | Buy | Truist |
| 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 |
4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)
4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)
4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)
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
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
Truist initiated coverage of Larimar Therapeutics with a rating of Buy and set a new price target of $18.00
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
4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)
4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)
4 - Larimar Therapeutics, Inc. (0001374690) (Issuer)
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
SCHEDULE 13G/A - Larimar Therapeutics, Inc. (0001374690) (Subject)
8-K - Larimar Therapeutics, Inc. (0001374690) (Filer)
SCHEDULE 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/A - Larimar Therapeutics, Inc. (0001374690) (Subject)