Noticias y eventos de Lexeo Therapeutics Inc (LXEO)LXEOLexeo Therapeutics Inc

Lexeo Acquires Mantle Therapeutics for $21.3 Million

Lexeo Therapeutics announced a series of strategic transactions to expand its presence in Friedreich ataxia, including the signing of a definitive agreement to acquire Mantle Therapeutics and three new research collaborations supporting cerebellar-targeted development opportunities for frataxin gene therapy. Together, these transactions will simultaneously expand Lexeo's vision and capabilities beyond gene therapy, deepen the company's focus on the multisystem burden of FA, and add multiple therapeutic approaches designed to increase or restore frataxin in the brain. Under the terms of the agreement, Lexeo will pay Mantle shareholders $8.3M in upfront consideration, consisting of a combination of cash and equity. The agreement also provides for up to $13M in success-based milestone payments, payable in a combination of cash and equity upon the achievement of future clinical and regulatory milestones, bringing the total potential consideration to $21.3M. Subject to customary closing conditions, the transaction is expected to close in the third quarter of 2026

Lexeo Therapeutics Initiates Pivotal Study for LX2006

"We closed the second quarter with significant momentum, highlighted by the initiation of SUNRISE-FA 2, the pivotal study for LX2006 in Friedreich ataxia cardiomyopathy," said R. Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics. "With SUNRISE-FA 2 now underway, we are focused on execution and advancing what we believe could be the first disease-modifying gene therapy for FA cardiomyopathy. Beyond LX2006, we continue to advance LX2020 in PKP2 arrhythmogenic cardiomyopathy and are pleased to have recently received RMAT designation from the FDA, an important milestone that reinforces the strength of the emerging clinical evidence and supports the potential expedited development of the program. With multiple value-driving catalysts ahead and a strong balance sheet to support our key clinical and regulatory milestones, we believe Lexeo is well positioned to deliver on our mission of transforming the treatment of genetically defined diseases."

Lexeo Therapeutics Finalizes SUNRISE-FA 2 Trial Protocol

Lexeo Therapeutics announced that the company has finalized the SUNRISE-FA 2 pivotal trial protocol and statistical analysis plan intended to provide clinical evidence to support the submission of a biologics license application to the FDA for gene therapy candidate LX2006 under the accelerated approval pathway in 2028. "FARA congratulates the Lexeo Therapeutics team on this important milestone and is deeply grateful for their commitment to advancing the first gene therapy program for Friedreich ataxia," said Jennifer Farmer, Chief Executive Officer of the Friedreich's Ataxia Research Alliance. "We also thank the participants and investigators in the SUNRISE-FA Phase I/II study, whose courage paved the way for this pivotal trial. We commend Lexeo for designing SUNRISE-FA 2 with scientific rigor while recognizing that a sham or placebo design is neither necessary nor appropriate in the context of gene therapy and adding a pediatrics arm to this study, putting patients first as we work urgently toward the first approved treatment for FA cardiomyopathy." The FDA has confirmed that no additional nonclinical bridging studies are required and Lexeo may use its optimized, high-yield Sf9-baculovirus final manufacturing process to initiate dosing in the SUNRISE-FA 2 pivotal study. Clinical drug product has been manufactured at commercial scale and is immediately available for patient dosing. Lexeo remains in ongoing discussions with the FDA regarding the confirmatory evidence strategy, including the potential use of certain secondary endpoints at the 12-month time point in SUNRISE-FA 2 to support full approval, and will provide an update once finalized. Based on the study size and duration of SUNRISE-FA 2, as well as expected PPQ and process validation requirements, Lexeo expects a topline data readout in the second half of 2027 and a BLA submission under the accelerated approval pathway in the first half of 2028.