Finalized SUNRISE-FA 2 open-label, pivotal trial protocol and SAP for LX2006 in support of accelerated approval pathway; topline data expected in second half of 2027 Initiated SUNRISE-FA 2 with first patient enrolled into pivotal study in June; site activation efforts ongoing CLARITY-FA enrollment
RMAT designation granted based on recent interim clinical data from ongoing Phase I/II clinical trial evaluating LX2020 for PKP2-ACM LX2020 now holds RMAT, Orphan Drug and Fast Track designations by the FDA NEW YORK, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc.
Published findings in JAMA Cardiology demonstrate LX2006 generally well tolerated, with early signs of efficacy in Phase I/II studies SUNRISE-FA 2 pivotal study for LX2006 on track to initiate in Q2 2026 with topline data expected in 2H 2027 NEW YORK, June 17, 2026 (GLOBE NEWSWIRE) -- Lexeo
SUNRISE-FA 2 study parameters include LVMI primary endpoint, 6-month topline efficacy analysis, inclusion criteria focused on abnormal baseline LVMI and open-label trial design BLA supportive manufacturing strategy includes flexible process validation, including reduced PPQ manufacturing batches
NEW YORK, May 19, 2026 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, today announced that the Company will participate in a fireside chat at the 2026 RBC Capital Markets
SUNRISE-FA 2 open-label, pivotal trial protocol and SAP for LX2006 submitted to FDA in Q1 2026; Awaiting final FDA feedback Multiple presentations highlighting progress across cardiac genetic medicine pipeline and optimized, Sf9-baculovirus AAV manufacturing platform to be presented at ASGCT 2026
Oral and poster presentations highlight progress across cardiac genetic medicine pipeline and optimized, Sf9-baculovirus AAV manufacturing platform NEW YORK, April 27, 2026 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering
SUNRISE-FA 2 open-label, pivotal trial protocol and SAP for LX2006 submitted to FDA in Q1 2026 following Type B meeting; study initiation on track for 1H 2026 First CMC Development and Readiness Program (CDRP) meeting for LX2006 in Q1 2026; aligned with FDA on flexible approach to process
NEW YORK, March 03, 2026 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, today announced that the Company will participate in a fireside chat at the Leerink Global Healthcare