Lexeo Therapeutics Inc

Lexeo Therapeutics Inc(LXEO)资讯与事件

$4.860

-0.127 (-2.61%)收盘时

LXEO 资讯

LXEO 事件

8/12 07:30

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."

6/15 07:30

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.

6/4 14:20

FDA Pledges to Prevent Political Interference in Meeting with Rare Disease Nonprofits

Executives from 15 rare disease-focused nonprofits met on Wednesday with acting FDA Commissioner Kyle Diamantas and senior staff. In the meeting, Diamantas pledged to prevent political interference, Endpoint News' Zachary Brennan reports. Publicly traded large-cap drugmakers include AstraZeneca (AZN), Bristol Myers (BMY), Eli Lilly (LLY), GSK (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Biotech stocks include Replimune (REPL), Moderna (MRNA), Sarepta (SRPT), Xencor (XNCR), PTC Therapeutics (PTCT), Biohaven (BHVN), Edgewise Therapeutics (EWTX), Design Therapeutics (DSGN), Ultragenyx (RARE), Dyne Therapeutics (DYN), Wave Life Sciences (WVE), MeiraGTx (MGTX), uniQure (QURE), Regenxbio (RGNX), Novavax (NVAX) and Lexeo Therapeutics (LXEO).

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