Larimar Therapeutics, Inc. - LRMR STOCK NEWS

Larimar Therapeutics (Nasdaq: LRMR) announced a clinical hold by the FDA on its CTI-1601 program due to mortalities observed in a non-human primate toxicology study. The company will not proceed with its planned private placement financing. CEO Carole Ben-Maimon emphasized patient safety and confirmed ongoing evaluation of data to comply with FDA requirements, potentially delaying upcoming trials into 2022. Larimar has $81.4 million in cash, sufficient for operations through mid-2022, and continues to believe in a viable path for CTI-1601’s development.

Larimar Therapeutics (Nasdaq: LRMR) announced a private placement financing raising approximately $95 million. The transaction involves the issuance of around 7,096,048 shares at a price of $13.43 per share. The funds will support the clinical development of CTI-1601, a treatment for Friedreich's ataxia, and other corporate purposes. Notable investors include Deerfield Management and RA Capital Management. The placement is expected to close by May 25, 2021.

Larimar Therapeutics (Nasdaq: LRMR) announced that the European Medicines Agency granted Priority Medicines (PRIME) designation for CTI-1601, a recombinant fusion protein aimed at treating Friedreich’s ataxia (FA). This designation comes after positive data from nonclinical and Phase 1 clinical studies, indicating that CTI-1601 can deliver human frataxin effectively. Larimar also holds multiple designations from the FDA, facilitating its development process. The company plans to initiate further clinical trials in the latter half of the year, enhancing its position in addressing rare diseases.

Larimar Therapeutics announced promising results from its Phase 1 clinical trial of CTI-1601, aimed at treating Friedreich's ataxia. The study demonstrated that daily subcutaneous injections over 13 days significantly increased frataxin levels in various tissues compared to placebo, achieving levels similar to healthy carriers. Safety data indicated that CTI-1601 was well tolerated without serious adverse events. The company plans future trials, including a pediatric study. This breakthrough could address critical unmet needs in FA treatment.

Larimar Therapeutics (Nasdaq: LRMR) reported its Q1 2021 results, highlighting significant progress in its Phase 1 trial for Friedreich's ataxia (FA). The company has cash and investments amounting to $81.4 million as of March 31, 2021, with a net loss of $12.1 million or $0.76 per share. The increase in R&D expenses to $9.0 million reflects higher clinical costs and personnel hiring. Management announced that topline data from the Phase 1 study will be revealed on May 11, 2021, which will include crucial pharmacodynamic data.

Learmar Therapeutics, Inc. (Nasdaq: LRMR) reported its preliminary Phase 1 findings for CTI-1601, a treatment for Friedreich's ataxia, indicating safety and tolerability in doses up to 100 mg. The company holds $92.6 million in cash as of December 31, 2020, despite a net loss of $42.5 million for the year, reflecting increased R&D costs due to clinical trials and personnel. Topline data from ongoing placebo-controlled trials is anticipated in Q2 2021, alongside the initiation of new trials aimed at further advancing CTI-1601's development.

BALA CYNWYD, Pa., Feb. 18, 2021 – Larimar Therapeutics (Nasdaq: LRMR) announced that Dr. Carole Ben-Maimon, CEO, will present at the SVB Leerink 10th Annual Global Healthcare Conference from February 22-26, 2021. The presentation is scheduled for February 26, 2021, at 8:00 AM ET, in a fireside chat format. Larimar is a clinical-stage biotech firm focused on therapies for rare diseases, notably evaluating CTI-1601 for Friedreich’s ataxia. More information can be found via their website.

Larimar Therapeutics has been added to the NASDAQ Biotechnology Index effective December 21, 2020. This index tracks biotechnology and pharmaceutical companies on the NASDAQ exchange. Larimar, focusing on treatments for complex rare diseases, is developing its lead compound, CTI-1601, for Friedreich’s ataxia. The index’s recognition may enhance visibility and potentially attract more investors to Larimar, reflecting its active involvement in the biotechnology sector.

Larimar Therapeutics (Nasdaq: LRMR) has completed dosing in its Phase 1 single ascending dose (SAD) clinical trial for CTI-1601, aimed at treating Friedreich’s ataxia (FA). Preliminary data suggests that the drug was well tolerated at doses up to 100 mg, with no serious adverse events reported. The company plans to release topline data from both the SAD and ongoing multiple ascending dose (MAD) trials in Q2 2021. CTI-1601 is designed as a frataxin replacement therapy, with potential future trials for patients under 18 years expected in the second half of 2021.