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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 announced its 2022 corporate priorities, emphasizing a focused strategy on advancing gene therapies for hemophilia B, Fabry disease, and Gaucher disease. The FLT180a B-LIEVE trial for hemophilia B commenced in Q4 2021, ahead of schedule. The FLT201 Phase 1/2 trial for Gaucher disease is expected to initiate by year-end 2021. A workforce reduction of approximately 25% was also announced to streamline operations, extending the company’s cash runway into Q2 2023. Future data from ongoing trials is anticipated throughout 2022.
Freeline Therapeutics (FRLN) presented long-term data from its B-AMAZE trial at the ASH Annual Meeting, showing sustained FIX expression up to 3.5 years post-treatment with FLT180a for hemophilia B. The results suggest potential for normal Factor IX levels with low vector doses. The company has also launched the B-LIEVE trial ahead of schedule, aiming to confirm dosing strategies and supportive immune management for the upcoming Phase 3 trial. Interim data from B-LIEVE is expected in mid-2022.
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) announced on December 6, 2021, that it granted stock options to its new Chief Medical Officer, Pamela Foulds, MD, and another employee. The total options issued were 240,000 and 7,200 shares respectively. This grant, compliant with Nasdaq Listing Rule 5635(c)(4), serves as a material inducement for the new hires. The options have an exercise price of $2.38 per share, with a ten-year maximum term and a four-year vesting schedule. Freeline is focused on advanced AAV-mediated gene therapies for severe inherited diseases.
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) announced its participation in the Evercore ISI 4th Annual HealthCONx Conference on December 2, 2021. CEO Michael Parini will engage in a Fireside Chat at 3:55 p.m. EST. A webcast will be accessible for 90 days on the Investors section of Freeline’s website. The company focuses on AAV-mediated gene therapies for severe inherited diseases, with ongoing programs in hemophilia B and Fabry disease.
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) will participate in the Stifel 2021 Virtual Healthcare Conference on November 15, 2021, at 1:20 p.m. ET. CEO Michael Parini is scheduled for a Fireside Chat. A webcast of this event will be available for 90 days on the Freeline website. Additionally, senior management will hold virtual one-on-one meetings with investors on November 16. Freeline focuses on developing AAV-mediated gene therapies for inherited debilitating diseases, with programs targeting Hemophilia B and Fabry disease.
Freeline Therapeutics (Nasdaq: FRLN) announced promising results from its MARVEL-1 trial for FLT190 treating Fabry disease, showing sustained α-Gal A expression for over two years in the first patient and near-normal levels in the second patient, who has been off enzyme replacement therapy for over 16 weeks. However, a case of mild myocarditis was reported. The company also provided updates on FLT201 for Gaucher disease and FLT180a for hemophilia B, with trials expected to initiate in Q1 2022. Financially, cash reserves decreased to $136.4 million, but Freeline expects to fund operations into Q1 2023.
Freeline Therapeutics (Nasdaq: FRLN), a biotechnology company focused on gene therapies for serious inherited diseases, announced the presentation of long-term data from its Phase 1/2 B-AMAZE trial on FLT180a, targeting hemophilia B. The findings will be showcased at the 63rd American Society of Hematology Annual Meeting in Atlanta from December 11-14, 2021. The session will highlight how normal Factor IX expression can prevent treatment-requiring spontaneous bleeds in patients post-therapy. This research is part of Freeline's broader commitment to innovative gene therapies.
On November 3, 2021, Freeline Therapeutics Holdings plc (Nasdaq: FRLN) announced the grant of non-statutory options to three new employees, totaling 69,800 ordinary shares and 4,250 restricted share units (RSUs). These options, with an exercise price of $3.01 per share, were approved by an independent remuneration committee and are part of the 2021 Equity Inducement Plan. The options vest over four years, with a portion vesting after the first year. Freeline is focused on developing gene therapies for inherited diseases, including Hemophilia B and Fabry disease.
Freeline Therapeutics announced the initiation of clinical trials for FLT201, targeting Gaucher disease Type 1. The FDA and the European Commission granted Orphan Drug Designation for FLT201, marking a significant milestone for the company. FLT201 uses a proprietary GCase variant to potentially improve therapeutic outcomes over current treatments. The Phase 1/2 dose-finding trial is expected to begin by year-end 2021, with clinical data anticipated in 2022. Freeline aims to provide a one-time gene therapy solution, reducing the treatment burden on patients.
Freeline Therapeutics (Nasdaq: FRLN), a clinical-stage biotechnology firm, announced its CEO, Michael Parini, will present at two upcoming virtual investor conferences. The H.C. Wainwright 23rd Annual Global Investment Conference is set for September 13, 2021, with a fireside chat available on-demand. The Morgan Stanley 19th Annual Global Healthcare Conference will take place on September 15, 2021, at 8:45 a.m. ET. Both webcasts will be accessible for 90 days on the company’s website. Freeline focuses on AAV-mediated gene therapies for inherited systemic diseases.
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