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Freeline Therapeutics Holdings plc (Nasdaq: FRLN) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing transformative gene therapies for chronic and debilitating diseases. The company's focus lies primarily on gene therapy solutions that address unmet medical needs, utilizing a next-generation AAV gene therapy platform developed by Professor Amit Nathwani, a leading authority in hematology from University College London (UCL).
Freeline's flagship program is FLT201, a highly differentiated gene therapy candidate targeting Gaucher disease type 1. This condition, caused by mutations in the GBA1 gene, leads to a deficiency in the glucocerebrosidase (GCase) enzyme, resulting in harmful substrate accumulation in organs such as the spleen, liver, bone, and lungs. FLT201 employs a rationally engineered longer-acting GCase variant designed to produce sustained enzyme levels and penetrate deeper tissues, potentially halting disease progression and improving patient outcomes with a single treatment. Early clinical data from the GALILEO-1 trial highlight the therapy’s potential, showing substantial reductions in key biomarkers and robust increases in plasma GCase activity.
Building on its work in Gaucher disease, Freeline has initiated a research program targeting GBA1-linked Parkinson’s disease. This program aims to extend the therapeutic benefits of its engineered GCase variant to patients suffering from Parkinson's disease due to GBA1 mutations. These mutations significantly increase the risk of Parkinson’s disease, leading to earlier onset, more severe symptoms, and faster progression to dementia. The preclinical data for this program is promising, showcasing the gene therapy’s enhanced enzyme activity in various cell lines.
Headquartered in the UK, with operations in the United States, Freeline is driven by its commitment to employing innovative gene therapy techniques to provide life-changing treatments. The company leverages proprietary AAVS3 capsid technology and novel promoters and transgenes to deliver functional copies of therapeutic genes to liver cells, ensuring persistent and effective protein expression. Freeline’s pipeline promises significant advancements, with FLT201 leading the charge in ongoing clinical trials and additional programs in the research phase.
Freeline's recent achievements and financial updates reflect its proactive stance in advancing its mission. The company’s financial results for the second quarter of 2023 reveal significant progress and a solid strategic focus, emphasizing the advancement of FLT201 as its top priority. The successful dosing of patients in the GALILEO-1 trial and the unveiling of the GBA1-linked Parkinson’s disease program underline Freeline's relentless pursuit of innovative treatments for genetic disorders.
Freeline Therapeutics (Nasdaq: FRLN) announces leadership change with Michael J. Parini appointed as CEO, succeeding Theresa Heggie. The company remains on track to advance three clinical programs by year-end, including FLT180a for Hemophilia B and FLT201 for Gaucher disease. Financial results show a cash position of $164.7 million as of June 30, 2021, enabling operations into Q1 2023. R&D expenses rose to $48.1 million, reflecting increased trial investments. Strategic priorities include advancing the pipeline and enhancing operational efficiencies.
Freeline Therapeutics announced that it will report its second quarter 2021 financial results on August 16, 2021. The company reiterated its unchanged guidance for key clinical milestones in 2021. Notable upcoming milestones include the FLT190 Phase 1/2 study for Fabry disease, FLT180a Phase 1/2 study for Hemophilia B, and FLT201 Phase 1/2 study for Gaucher disease Type 1. Additionally, Chief Medical Officer Julie Krop will be leaving the company, with Alison Long stepping in as interim CMO.
Freeline Therapeutics (Nasdaq: FRLN) has announced a leadership change with the appointment of James "Jay" Bircher as Chief Technical Operations Officer, effective July 1, 2021. Bircher brings nearly 30 years of operational expertise in biotechnology and will oversee regulatory compliance and manufacturing. Amit Nathwani, MD, PhD, will serve as interim Chief Scientific Officer following the departure of Romuald Corbau. This transition aims to bolster Freeline’s capabilities in advancing AAV gene therapies, with plans for a third clinical program by year-end 2021.
Freeline Therapeutics (FRLN) has completed dosing in the lowest dose cohort of its Phase 1/2 MARVEL-1 clinical trial for FLT190, a gene therapy for Fabry disease. CEO Theresa Heggie highlighted this milestone as a significant step forward, aided by easing COVID-19 restrictions and expanded study sites. The trial aims to evaluate safety and efficacy across four dose levels in about 10 adult males. Results showcasing FLT190's potential are expected by year-end, with the study monitoring various health metrics over nine months post-dosing.
Freeline Therapeutics Holdings plc (FRLN) reported Q1 2021 financial results, highlighting significant advancements in its gene therapy programs. The FLT190 Phase 1/2 trial for Fabry disease is progressing well, with data presentations expected by year-end. The company anticipates initiating FLT201 for Gaucher disease Type 1 by year-end, and the FLT180a trial for Hemophilia B is on track for site initiation. Cash and equivalents stand at $195.8 million. However, R&D expenses rose to $23.9 million, reflecting increased investments in clinical trials.
LONDON, May 12, 2021 – Freeline Therapeutics Holdings (Nasdaq: FRLN) announced participation in a Fireside Chat at the 2021 RBC Capital Markets Global Healthcare Conference on May 18 at 4:50 pm EDT. The event will include a webcast available in the Investors section of Freeline's website. Freeline focuses on developing AAV gene therapies for inherited diseases, with ongoing clinical programs targeting Hemophilia B and Fabry disease. The company aims to deliver one-time treatments that provide functional cures through its innovative gene therapy platform.
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) presented six research posters at the ASGCT Annual Meeting 2021, showcasing advancements in their gene therapy platform. Key highlights include:
- Establishment of a high-throughput suspension platform for rAAV manufacturing.
- Development of a suspension cell-based AAV manufacturing process reducing costs.
- Innovative dosing assays enhancing vector genome titer quantification.
- Positive results from FLT190 for Fabry disease and FLT201 for Gaucher disease Type 1.
These findings underscore Freeline's commitment to pioneering gene therapies for debilitating diseases.
Freeline Therapeutics (Nasdaq: FRLN) announced six poster presentations at the ASGCT Annual Meeting from May 11-14, 2021. The presentations will showcase advancements in gene therapy, highlighting three gene therapies expected in clinical trials by year-end. Key topics include FLT201 for Gaucher Disease and AAV gene therapy for Fabry Disease. CEO Theresa Heggie emphasized the significance of these presentations in demonstrating the company’s ongoing progress and innovative approaches in gene therapy, which aim to provide functional cures for inherited diseases.
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) will participate in two upcoming virtual investor conferences. The Company will present at Chardan’s 5th Annual Genetic Medicines Manufacturing Summit on April 26, 2021, at 9:45 am ET. Additionally, Freeline will engage in one-on-one meetings at the 7th Annual Truist Securities 2021 Life Sciences Summit on May 4, 2021. The presentation from the Chardan summit will be accessible on Freeline's investor website. Freeline develops AAV-mediated gene therapies aimed at treating inherited systemic diseases.
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) reported strong financial results for 2020 and outlined plans for three AAV gene therapy programs by year-end 2021. With a year-end cash position of $230 million, the company anticipates funding its upcoming clinical milestones. Phase 1/2 trial data for FLT180a, targeting Hemophilia B, indicates potential for durable normalization of Factor IX activity. Progress on FLT190 for Fabry disease and FLT201 for Type 1 Gaucher disease is also on track, with clinical trials expected to initiate by year's end.
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