Larimar Therapeutics (LRMR) Surges On FDA Breakthrough Therapy Designation

The designation covers adults and children with the rare disease and was based on data from an ongoing open-label study. Here's what investors need to know.

Benzinga • 11 hours ago

Larimar Therapeutics Announces FDA Breakthrough Therapy Designation for Nomlabofusp in FA and Reiterates Planned BLA Submission in June 2026

Nomlabofusp program granted Breakthrough Therapy Designation for the treatment of adults and children with FA based on FDA's review of available clinical data from open label study FDA written communications after recent START meeting continue to align with use of skin FXN to support BLA submission seeking accelerated approval Topline open label study data to support BLA submission expected in Q2 2026 Planned BLA submission seeking accelerated approval on track for June 2026; U.S. launch targeted for first-half 2027, if approved BALA CYNWYD, Pa., Feb. 24, 2026 (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. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to nomlabofusp, a frataxin (FXN) protein replacement therapy with disease modifying potential, for the treatment of adults and children with Friedreich's ataxia (FA).

GlobeNewsWire • 16 hours ago

Larimar Therapeutics: The Market Is Mispricing A Potential Standard Of Care

Larimar Therapeutics is deeply undervalued, trading at ~$3.40 despite a de-risked safety profile and a clear regulatory path for its lead asset. Nomlabofusp directly addresses Friedreich's Ataxia's root cause, with a mechanism that delivers missing frataxin, potentially supplanting current standard-of-care. Anaphylaxis concerns have been mitigated by new dosing protocols and FDA-approved trial modifications, positioning LRMR for a potential re-rating.

Seeking Alpha • Jan 16, 2026

Larimar Therapeutics, Inc. (LRMR) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript

Larimar Therapeutics, Inc. (LRMR) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript

Seeking Alpha • Jan 14, 2026

Larimar Therapeutics to Present at the 44th Annual J.P. Morgan Healthcare Conference

BALA CYNWYD, Pa., Dec. 18, 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 44th Annual J.P.

GlobeNewsWire • Dec 18, 2025

Top 3 Health Care Stocks That May Rocket Higher In December

The most oversold stocks in the health care sector presents an opportunity to buy into undervalued companies.

Benzinga • Dec 3, 2025

Larimar Therapeutics Reports Third Quarter 2025 Financial Results

In the open label (OL) study, after 6-months of daily nomlabofusp administration, 100% of participants (n = 10) achieved skin FXN levels similar to asymptomatic carriers Consistent directional improvement across mFARS, FARS-ADL, 9-HPT and MFIS after 1-year in OL study reinforces the potential of nomlabofusp to alter FA's disease course relative to a worsening in a FACOMS natural history study reference population Of 39 participants in OL study (and of 65 total participants who received at least 1 dose in all nomlabofusp studies), 7 experienced anaphylaxis in the first 6 weeks of dosing and returned to usual state of health after standard treatment; excluding these events, long term dosing of nomlabofusp was generally well tolerated including 8 participants on treatment for over 1 year  Anaphylaxis is more common upon re-exposure to a drug after a gap in dosing; in the OL study, of the 10 participants who had not had prior exposure to nomlabofusp only 1 experienced anaphylaxis (this reaction was one of the 7 events discussed above). Implementing a modified starting dose regimen designed to mitigate the risk of anaphylaxis events as agreed to by the FDA Modified starting dose regimen is also being incorporated into the Phase 3 protocol; Larimar continues to qualify global Phase 3 sites and prepare for study initiation and patient enrollment BLA submission seeking accelerated approval targeted in the second quarter of 2026 $175.4 million in cash, cash equivalents and marketable securities as of September 30, 2025, with projected cash runway into the fourth quarter of 2026 BALA CYNWYD, Pa.

GlobeNewsWire • Nov 5, 2025

Rosen Law Firm Encourages Larimar Therapeutics, Inc. Investors to Inquire About Securities Class Action Investigation – LRMR

NEW YORK--(BUSINESS WIRE)--Why: Rosen Law Firm, a global investor rights law firm, continues to investigate potential securities claims on behalf of shareholders of Larimar Therapeutics, Inc. (NASDAQ: LRMR) resulting from allegations that Larimar Therapeutics may have issued materially misleading business information to the investing public. So What: If you purchased Larimar Therapeutics securities you may be entitled to compensation without payment of any out of pocket fees or costs through a.

Business Wire • Oct 30, 2025

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Larimar Therapeutics, Inc. - LRMR

NEW YORK , Oct. 28, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Larimar Therapeutics, Inc. ("Larimar" or the "Company") (NASDAQ: LRMR). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext.

PRNewsWire • Oct 28, 2025

LRMR Investors Have Opportunity to Join Larimar Therapeutics, Inc. Fraud Investigation with the Schall Law Firm

LOS ANGELES , Oct. 16, 2025 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Larimar Therapeutics, Inc. ("Larimar" or "the Company") (NASDAQ: LRMR) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

PRNewsWire • Oct 16, 2025