Investing.com -- Wave Life Sciences Ltd (NASDAQ:WVE) stock rose 2.1% Monday after the clinical-stage biotechnology company announced it has regained full rights to WVE-006, its investigational RNA editing therapy for alpha-1 antitrypsin deficiency (AATD).
The company said it reached an agreement with GSK to take back control of the AATD program, as Wave is "well placed to efficiently advance" the therapy for this rare condition. Following this development, Wave plans to accelerate its registrational strategy for WVE-006 and engage with the FDA on a potential accelerated approval pathway, with regulatory feedback expected by mid-2026.
WVE-006 is designed as a first-in-class RNA editing therapeutic to correct the root cause of AATD, which affects approximately 200,000 individuals in the U.S. and Europe. The therapy aims to address both lung and liver manifestations of the disease, which currently has limited treatment options.
"We have been eager to accelerate our registrational strategy for WVE-006 since reporting our interim data that achieved key AATD treatment goals in recapitulating the healthier MZ phenotype, including dynamic AAT production of over 20 micromolar during an acute phase response," said Paul Bolno, President and CEO at Wave Life Sciences.
Data from the 400 mg multidose cohort of the ongoing RestorAATion-2 clinical trial are expected in the first quarter of 2026, with additional data from the 600 mg cohort anticipated later in 2026.
Despite this change, Wave’s research collaboration with GSK continues, with GSK selecting a fourth program to advance to development candidate in January 2026. The company maintains its cash runway projection into the third quarter of 2028.
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