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Freeline Therapeutics Holdings plc - FRLN STOCK NEWS

Welcome to our dedicated page for Freeline Therapeutics Holdings plc news (Ticker: FRLN), a resource for investors and traders seeking the latest updates and insights on Freeline Therapeutics Holdings plc stock.

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.

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Freeline Therapeutics will present new data on its Gaucher and Parkinson’s disease programs at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting. The company will discuss clinical data from its Gaucher disease program, highlighting the potential of FLT201 gene therapy for better efficacy with a one-time treatment. Additionally, Freeline will share new data from its Parkinson’s disease research program, focusing on leveraging the enhanced stability of their rationally engineered GCase enzyme.
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Freeline Therapeutics Holdings plc (FRLN) has been acquired by Syncona Ltd through a sanctioned scheme of arrangement, with shareholders entitled to receive $0.433333 per share or $6.50 per ADS. The acquisition has led to the de-listing of Freeline ADSs from Nasdaq.
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Freeline Therapeutics Holdings plc (Nasdaq: FRLN) shareholders approve Bidco's acquisition proposal by Syncona Ltd for $6.50 per ADS in cash. The Acquisition is set to be effective on February 20, 2024, pending court approval and other closing conditions. ADSs expected to be delisted from Nasdaq on February 16, 2024.
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Freeline Therapeutics Holdings plc (FRLN) has agreed to be acquired by a portfolio company of Syncona Ltd (SYNC) for $6.50 per American Depositary Share (ADS), representing a 51% premium over the closing price prior to the announcement of Syncona's initial proposal on October 18. The acquisition is subject to the approval of Freeline's minority shareholders and is expected to close in the first quarter of 2024. Syncona will also provide $15 million in convertible debt financing to support Freeline's near-term capital needs and advancement of its gene therapy candidate in Gaucher disease.
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Freeline Therapeutics announces positive clinical data for its gene therapy candidate FLT201 for Gaucher disease. The data shows a substantial reduction in lyso-Gb1 levels, a biomarker of clinical response, in the first patient treated with FLT201. Increases in plasma GCase activity and normalization of cellular GCase levels continue to be observed in the first two patients. FLT201 is well-tolerated with no serious adverse events. The Phase 1/2 GALILEO-1 trial is ongoing.
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Freeline Therapeutics reports positive initial safety, tolerability, and enzyme activity data for its gene therapy candidate FLT201 in Gaucher disease. FLT201 demonstrated robust increases in plasma GCase enzyme activity, with up to a 700-fold increase over baseline. Leukocyte GCase activity also normalized in both patients, indicating cellular uptake from plasma. The therapy was well tolerated with no serious adverse events. The company plans to treat a third patient at the same dose to gather more data before deciding on further dosing. A webcast presentation discussing the results will be held today.
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Freeline Therapeutics completes dosing in the first cohort of Phase 1/2 GALILEO-1 trial of FLT201 in Gaucher disease. Initial clinical data expected in Q3 2023. Company extends research program for GBA1-linked Parkinson's disease. Financial results for Q2 2023 reported.
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Freeline Therapeutics Holdings plc (Nasdaq: FRLN) will be participating in two upcoming investor conferences in August. CEO Michael Parini will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on August 7. The management will also participate in one-on-one meetings at the Wedbush Healthcare Conference from August 8-9 in New York City. A live webcast of the BTIG fireside chat will be available on Freeline's website.
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Freeline Therapeutics Holdings plc (Nasdaq: FRLN) will host a virtual Key Opinion Leader (KOL) event on August 1, 2023, to discuss its adeno-associated virus (AAV) gene therapy candidate in Gaucher disease Type 1. The event will feature Gaucher disease expert, Dr. Reena Sharma, and the Freeline leadership team will provide a corporate overview and outline the clinical progress of FLT201.
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FAQ

What is Freeline Therapeutics Holdings plc focused on?

Freeline Therapeutics is focused on developing and commercializing transformative gene therapies for chronic and debilitating diseases.

What is FLT201?

FLT201 is Freeline's lead gene therapy candidate for Gaucher disease type 1, designed to deliver a longer-acting GCase enzyme variant to halt disease progression with a one-time treatment.

What are GBA1-linked Parkinson’s disease and Freeline's approach to it?

GBA1-linked Parkinson’s disease is a form of Parkinson's disease caused by mutations in the GBA1 gene. Freeline is developing a gene therapy leveraging their engineered GCase variant to address this condition.

Where is Freeline Therapeutics headquartered?

Freeline Therapeutics is headquartered in the UK, with additional operations in the United States.

What technology does Freeline Therapeutics use for their gene therapies?

Freeline employs proprietary AAVS3 capsid technology along with novel promoters and transgenes to deliver therapeutic genes into human liver cells.

What is the significance of the GALILEO-1 trial?

The GALILEO-1 trial is a Phase 1/2 clinical study evaluating the safety and efficacy of FLT201 in patients with Gaucher disease type 1, showing promising initial clinical data.

How many people are affected by Gaucher disease?

Gaucher disease affects approximately 18,000 people in the United States, UK, and other major European countries, including France, Germany, Spain, and Italy.

What are the recent developments in Freeline's FLT201 program?

Recent developments include positive initial clinical data from the GALILEO-1 trial, showing a reduction in Gaucher disease biomarkers and sustained GCase activity in treated patients.

What was announced in Freeline’s latest financial report?

Freeline’s latest financial report highlighted significant progress in their clinical programs, specifically FLT201, and introduced their research program for GBA1-linked Parkinson’s disease.

What is Freeline’s approach to addressing chronic diseases?

Freeline’s approach involves developing gene therapies using their proprietary AAV vector technology to replace dysfunctional genes and provide long-term treatment benefits in chronic diseases.

Freeline Therapeutics Holdings plc

Nasdaq:FRLN

FRLN Rankings

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28.24M
26.80M
1.1%
45.88%
0.55%
Biological Product (except Diagnostic) Manufacturing
Manufacturing
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United Kingdom
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