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Tag: LRMR

  • Larimar Therapeutics Inc (LRMR) stock lost 56.99% in pre-market. Here’s why

    The stock price of Larimar Therapeutics Inc (LRMR) closed the recent trading session at $8.37. The stock kept oscillating between $8.31 and $8.97. During the last check, the stock of LRMR declined 56.99% to $3.6, in the pre-market. The company filed the form SC 13G/A with the SEC, on February 14, 2022. The form refers to the amendment in the form SC 13G.

    LRMR News:

    On February 14, 2022, the company provided the update on CTI-1601 clinical trials through a press release. Larimar Therapeutics Inc announced that the company received feedback on the clinical trials for CTI-1601 by the Food And Drug Administration. The feedback from the FDA stated that it is sustaining the hold on the clinical trials of CTI-1601. The feedback further stated that supplementary data is required to settle the hold. The company expects to join with the FDA to decide how to give out further information.

    The trials were put on a hold following the company’s notice to the mortality office. the mortalities occurred at the highest level of dosage in an NPH toxicology study for 26 weeks. The feedback expects the submission of a thorough report from the company regarding the 26-week NHP toxicology study

    CEO Remarks:

    The CEO of Larimar Therapeutics Inc (LRMR), Carole Ben-Maimon, said that patient safety is crucial for the company. He added that their ensuing step is to settle on how they can meet their solicitation in the best and expedient manner.

    He concluded that they stay focused on the further turn of events of CTI-1601’s and are pursuing this objective with a strong financial position. They mean to work under a cost reduction plan while settling the clinical hold.

    About LRMR:

    Larimar Therapeutics, Inc is a clinical-stage biopharmaceutical organization, which takes part in the examination, improvement, and commercialization of novel therapeutics mitochondrial issues and Friedreich’s ataxia. The company has its headquarter in Bala Cynwyd, Pennsylvania, United States of America (USA).

  • Larimar Therapeutics, Inc. (LRMR) Stock on the Rise as Resolution of FDA Clinical Hold Continues to Develop

    Larimar Therapeutics, Inc. (LRMR) stock prices were up by a marginal 1.54% as of the market closing on July 2nd, 2021, bringing the price per share up to USD$9.89 at the end of the trading day. After hours trading saw the stock surge by 10.21%, bringing it up to USD$10.90.

    Clinical Hold for CTI-1601

    May 25th 2021 saw the company announce that the U.S. Food and Drug Administration had placed a clinical hold on LRMR’s ongoing CTI-1601 clinical program. As a result, the company did not complete its previously announced private placement financing. The clinical trial is for the treatment of patients with FA who are unable to produce enough human frataxin, with CTI-1601 serving is a recombinant fusion protein that is delivered to patients’ mitochondria.

    Contextualizing the Hold

    The clinical hold came after the company’s reporting to the FDA in regard to mortalities occurring at the highest dose levels in an ongoing 180-day non-human primate toxicology study. The study was designed to support extended CTI-1601 treatment in patients. The FDA implemented the hold in light of needing a full study report from the company’s NHP study, with a restriction on the initiation of additional clinical trials until the report has been submitted and approved by the FDA.

    Effects of FDA Decision

    The disappointing formal clinical hold notification does not, however, change the company’s previously stated strategy for the clinical development of CTI-1601. LRMR plans to complete its NHP toxicology study, assess the data, and discuss the data with the FDA in order to obtain prior consent for the commencement of their Jive and pediatric MAD trial. Patient safety continues to be a top priority, with the company confident that despite the hiccup, the path forward is still in place.

    Deferral of Trials

    With the added regulatory requirements associated with the formal clinical hold, the company is entertaining the possibility of deferring the initiation of its clinical trials. The trials are being considered to be pushed up to 2022. Despite the termination of the planned private placement financing, the company reported a solid cash position as of March 31st, 2021. Having reported USD$81.4 million in cash and cash equivalents, the company anticipates being able to fund its operations through to the first half of 2022.

    Future Outlook for LRMR

    Confident in the timely resolution of the speedbumps in the road towards the commercialization of its treatment candidates, LRMR is poised to continue its trajectory of success. The company is keen to address the FDA’s requirement so it can continue pushing for the development of its various clinical trials.