Wave Life Sciences Announces Plans to Accelerate Regulatory Engagement with Full Control of WVE-006 for Alpha-1 Antitrypsin Deficiency

Core Insights - Wave Life Sciences has regained full rights to WVE-006, an investigational RNA editing therapeutic for alpha-1 antitrypsin deficiency (AATD), from GSK, allowing the company to advance its development strategy independently [1][2] - The company plans to engage with the FDA regarding a potential accelerated approval pathway for WVE-006, with regulatory feedback expected by mid-2026 [1][2] - Wave anticipates data from the 400 mg multidose cohort of the RestorAATion-2 clinical trial in the first quarter of 2026, with additional data from the 600 mg cohorts expected later in 2026 [1][2] Company Developments - Wave Life Sciences is focused on RNA medicines and has a diversified pipeline that includes clinical programs for AATD, obesity, Duchenne muscular dystrophy, and Huntington's disease [6] - The company has a strong cash runway, expecting to fund operations into the third quarter of 2028, not including potential future milestone payments from its collaboration with GSK [4] - Wave's collaboration with GSK continues to expand, with a fourth program selected for advancement, potentially leading to up to $2.8 billion in milestone payments and tiered royalties [3] Clinical Trial Progress - WVE-006 has shown promising interim data, achieving key treatment goals for AATD, including significant AAT production during acute phase response [2] - The ongoing RestorAATion-2 clinical trial is on track, with data from the 400 mg cohort expected in early 2026 and further data from the 600 mg cohort anticipated later that year [1][2]

Wave Life Sciences .- Wave Life Sciences Announces Plans to Accelerate Regulatory Engagement with Full Control of WVE-006 for Alpha-1 Antitrypsin Deficiency - Reportify