Welcome to our dedicated page for Larimar Therapeutics news (Ticker: LRMR), a resource for investors and traders seeking the latest updates and insights on Larimar Therapeutics stock.
Larimar Therapeutics, Inc. (NASDAQ: LRMR) is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, with its lead compound, nomlabofusp, in development as a potential treatment for Friedreich’s ataxia (FA). The Larimar news feed on Stock Titan aggregates the company’s press releases and related coverage so readers can follow key milestones in this rare disease program.
News about Larimar frequently centers on clinical data updates from the ongoing long-term open-label and open-label extension studies of nomlabofusp in FA. The company has reported increases in skin frataxin (FXN) levels with daily subcutaneous dosing, directional improvements in clinical outcome measures such as mFARS, FARS-ADL, 9-Hole Peg Test, and Modified Fatigue Impact Scale, and long-term safety observations including injection site reactions and anaphylaxis events. Larimar also publishes nonclinical findings that describe the mechanism of action and pharmacology of nomlabofusp as an FXN protein replacement therapy.
Another major category of LRMR news involves regulatory interactions and timelines. Larimar has disclosed written recommendations from the U.S. Food and Drug Administration on the safety database needed for its Biologics License Application and the agency’s openness to using skin FXN concentrations as a reasonably likely surrogate endpoint for an accelerated approval pathway. The company regularly issues press releases on these regulatory updates, its participation in the START pilot program, and its targeted timing for a BLA submission seeking accelerated approval.
Investors and followers will also see financial results and capital markets announcements, including quarterly operating and financial updates, underwritten public offerings of common stock, and the use of proceeds to fund nomlabofusp development and other pipeline plans. For a consolidated view of LRMR-related developments—spanning clinical, regulatory, and financing events—this news page provides an organized stream of Larimar’s own disclosures and market-facing communications.
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Lariamar Therapeutics (Nasdaq: LRMR) announced its participation in the Guggenheim Genomic Medicines and Rare Disease Days on April 3-4, 2023. The company will engage in a virtual fireside chat and 1x1 investor meetings, showcasing its focus on developing treatments for complex rare diseases.
The fireside chat is scheduled for April 4, 2023, at 4:35 PM ET, accessible via a live webcast link. Following the event, a replay will be available on Larimar's Events and Presentations page. Larimar Therapeutics is advancing its lead compound, CTI-1601, for Friedreich's ataxia and aims to create further treatments for rare diseases through its innovative platform.
Lakimar Therapeutics reported key updates on its Phase 2 trial of CTI-1601 for Friedreich's ataxia, with the first cohort fully enrolled as of March 14, 2023. The company expects to announce the next steps following an FDA review in Q2 2023. As of December 31, 2022, Larimar held cash and investments totaling $118.4 million, projecting a runway into 2H 2024. For Q4 2022, the net loss was $9.4 million (or $0.21 per share), an increase from the previous year. Total net loss for 2022 was $35.4 million, down from $50.6 million in 2021, indicating improved financial health amidst ongoing R&D investments.
Larimar Therapeutics, Inc. (Nasdaq: LRMR) has appointed Gopi Shankar, PhD, MBA, as the Chief Development Officer (CDO). Dr. Shankar brings over 20 years of experience from Johnson & Johnson, where he led significant R&D teams. He will focus on the strategic development of the company's clinical and R&D programs, particularly the CTI-1601 program aimed at treating Friedreich's ataxia. This therapy has received multiple designations from the FDA and EMA. The Board approved a stock option grant as part of his inducement package.
Larimar Therapeutics (LRMR) reported its Q3 2022 results, showcasing a net loss of $8.3 million, or $0.37 per share, compared to $16.8 million, or $0.92 per share in Q3 2021. The company raised approximately $75.2 million through equity offerings and had $124.7 million in cash as of September 30, 2022, projecting a cash runway into H2 2024. The first cohort of its Phase 2 trial for CTI-1601 in Friedreich's ataxia patients is underway, with updates expected in Q2 2023 and top-line data anticipated in H2 2023.