Shares of Wave Life Sciences Ltd (NASDAQ:WVE) rose 2.1% on Monday after the clinical-stage biotechnology company said it has regained exclusive control of WVE-006, its investigational RNA editing therapy targeting alpha-1 antitrypsin deficiency or AATD.
Wave said it reached an agreement with GSK that returns full rights to the AATD program to Wave, with the company stating it is "well placed to efficiently advance" the candidate for this rare disease. Following the change in program control, Wave plans to accelerate its registrational strategy for WVE-006 and pursue engagement with the U.S. Food and Drug Administration to explore a potential accelerated approval pathway. Wave expects to receive regulatory feedback by mid-2026.
WVE-006 is described by the company as a first-in-class RNA editing therapeutic intended to address the underlying cause of AATD. The condition is estimated to affect approximately 200,000 people across the U.S. and Europe, and produces both lung and liver complications for which treatment options are limited, according to Wave.
Paul Bolno, President and CEO of Wave Life Sciences, emphasized the company’s interest in advancing a registrational path after interim clinical results. "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," he said.
Wave provided a timeline for near-term clinical milestones. Data from the 400 mg multidose cohort in the ongoing RestorAATion-2 trial are expected in the first quarter of 2026, with additional results from the 600 mg cohort anticipated later in 2026.
Although control of the AATD program has reverted to Wave, the company's broader research collaboration with GSK remains active. The two companies continue to work together under their research agreement, and GSK has selected a fourth program to progress to development candidate status in January 2026.
On the financial side, Wave reiterated its cash runway projection, maintaining that available resources are expected to fund operations into the third quarter of 2028.
Market and sector context
The announcement primarily affects Wave Life Sciences and market participants focused on biotechnology and rare-disease therapeutics. Equity investors in small-cap biotech may view the regaining of rights and an accelerated regulatory engagement plan as material to the company’s clinical and commercial trajectory.