Freeline Therapeutics Holdings Plc Stock Price, News & Analysis

Freeline Therapeutics announced the appointment of Colin A. Love, PhD, to its Board of Directors, effective immediately. Dr. Love brings over 30 years of experience in the biopharmaceutical sector, including significant contributions at Amgen and BioVex. His expertise comes at a pivotal moment for Freeline as it advances towards the potential commercialization of its gene therapy pipeline. The company focuses on treating debilitating inherited diseases through innovative gene therapies, aiming to deliver long-term cures with single-dose treatments.

LONDON, March 2, 2021 (GLOBE NEWSWIRE) -- Freeline Therapeutics (Nasdaq: FRLN) announced that CEO Theresa Heggie will present at two virtual investor conferences in March. The presentations will take place at the H.C. Wainwright Global Life Sciences Conference on March 9, 2021, and the Barclays Global Healthcare Conference on March 10, 2021. Both presentations will be available on-demand on the Freeline website. The company, focused on gene therapies for inherited systemic diseases, has ongoing clinical programs for Hemophilia B and Fabry disease.

Freeline Therapeutics Holdings plc (Nasdaq: FRLN) announced the appointment of Michael J. Parini as President and Chief Operating Officer, effective March 15, 2021, as part of an executive leadership expansion. This follows the recent hiring of Stephen P. Diamond as General Counsel and David S. Arrington as Vice President of Investor Relations. Meanwhile, Brian M. Silver, the current CFO, will leave Freeline on April 30, 2021, to pursue new opportunities. The company is now searching for his replacement, aiming to enhance its operational and strategic functions to drive growth in gene therapy development.

Freeline Therapeutics (Nasdaq: FRLN) announced data demonstrating the potential of FLT201 for treating Gaucher disease, focusing on delivering β-glucocerebrosidase variant 85 effectively to target tissues inadequately addressed by existing enzyme replacement therapies. The company plans to begin first-in-human dose finding studies for FLT201 in late 2021. Highlights from recent presentations show FLT201's enhanced tissue penetration and efficacy, which could lead to improved patient outcomes. The proprietary AAVS3 capsid technology supports a 20-fold increase in GCase potency, aiming for substantial clinical advances.

Freeline Therapeutics announced a revision to its FLT180a program for Hemophilia B, responding to FDA feedback on the comparability of investigational drug products. A new Phase 1/2 dose confirmation trial is planned to begin by the end of 2021, with results expected by the end of 2022. The Phase 3 pivotal trial is targeted for mid-2023, aiming for a BLA submission by the end of 2024. The trial will assess the dose's safety and efficacy, using data from prior studies to guide dose selection.

Freeline Therapeutics (Nasdaq: FRLN) announced it will present at the 2021 EAHAD Virtual Congress on February 2, including two e-posters and one oral presentation about its AAV gene therapy for hemophilia and Gaucher disease. Key presentations include a study on FLT180a for severe Hemophilia B and insights from the CHESS II study. Additionally, at the WORLD Symposium on February 11, the company will present data on FLT201 targeting Type 1 Gaucher Disease. Presentations will be available online via the Freeline website post-event.

Freeline Therapeutics Holdings plc (Nasdaq: FRLN) announced its participation in two virtual conferences in January 2021, focusing on advancing gene therapy for patients with inherited systemic diseases. On January 8, CEO Theresa Heggie will join a panel at the LifeSci Partners 10th Annual Healthcare Corporate Access Event. On January 13, she will present at the 39th Annual J.P. Morgan Healthcare Conference, followed by virtual one-on-one meetings. Interested parties can access live webcasts on the company's investor relations website.

Freeline Therapeutics (Nasdaq: FRLN) announced promising updates from its Phase 1/2 B-AMAZE trial of FLT180a for severe hemophilia B, showing durable Factor IX (FIX) activity lasting nearly three years with no bleeds needing FIX supplementation. The company successfully concluded an End of Phase 2 meeting with the FDA and plans to start a pivotal Phase 2b/3 trial in H2 2021. Key findings include a tailored immune management strategy and dose selection aimed at achieving normal FIX levels in patients. This development marks progress towards providing functional cures for hemophilia B.

Freeline Therapeutics (Nasdaq: FRLN) announced management's participation in a fireside chat at the 3rd Annual Evercore ISI Health CONx Conference on December 3, 2020, from 08:00 to 08:20 am ET. The event will feature a live audio webcast available on Freeline's website, with a recording accessible for 90 days post-conference. Freeline specializes in systemic AAV-based gene therapy for chronic diseases, aiming to improve patient lives through potential one-time functional cures.