Catalyst overview
Research summary
This catalyst tracks a Failed discontinued for Inhaled AAT in Severe alpha-1 antitrypsin deficiency. The expected timing is based on the latest available company guidance and may change.
InnovAATe trial. 8/16/23- Advancing pivotal trial, positive feedback from EMA. 11/13/23- DSMB positive recommendation to continue trial w/o modification. Received FDA feedback. 8/13/25- Conduct an interim futility analysis by YE 2025. 12/08/25:- Interim futility analysis found low chance of benefit; InnovAATe Ph3 inhaled AAT trial discontinued.
Verification
Confirm timing and program details against the company announcement or filing.