Aerovate plunges as AV-101 fails in treatment of PAH

Shares of US drug developer Aerovate Therapeutics (Nasdaq: AVTE) plummeted 93% yesterday and were down a further 6.7% at $1.54 pre-market, after it revealed it would scrap a late-stage development of its lead investigational candidate.

Aerovate announced top-line results from the Phase IIb portion of the Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT), a Phase IIb/Phase III, randomized, double-blind, placebo-controlled, multi-national trial of AV-101, a novel dry powder inhaled formulation of imatinib, in adults with pulmonary arterial hypertension (PAH).

The primary endpoint for the Phase IIb portion of IMPAHCT is change in PVR compared with placebo. Results showed that, while AV-101 was well tolerated across all dose groups, the study did not meet its primary endpoint for improvement in PVR compared to placebo for any of the studied doses or show meaningful improvements in the secondary endpoint of change in six-minute walk distance (6MWD).