Aerovate Therapeutics Misses Primary Endpoint in Hypertension Trial, Shares Drop 93%

Shares in Aerovate Therapeutics (Nasdaq: AVTE) fell by almost 100% on Monday after the company announced topline results from its Phase 2b, trial of AV-101, a novel dry powder inhaled formulation of imatinib, in adults with pulmonary arterial hypertension (PAH).

The study missed its primary endpoint of improvement in pulmonary vascular resistance (PVR) compared to placebo, and failed to show meaningful improvements in the secondary endpoint of change in six minute walk distance (6MWD). Data from several additional secondary endpoints also failed to show meaningful improvements. Based on the results, Aerovate has made the decision to shut down the Phase 3 and long-term extension portions of the study.

Commenting on the news, Tim Noyes, Chief Executive Officer of Aerovate, said, “The results of the Phase 2b portion of IMPAHCT were unexpected and disappointing. Our immediate focus is on transparently sharing these findings with investigators, patients and the PAH community. In the coming weeks, we will engage closely with the IMPAHCT study advisory committee and the PAH community to thoroughly discuss these data and their implications.”

Pulmonary hypertension affects approximately 1% of people globally, and is twice as common in women as in men.

About Aerovate Therapeutics, Inc.

Aerovate is a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease. Aerovate’s initial focus is on advancing AV-101, its proprietary dry powder inhaled formulation of the drug imatinib for the treatment of patients with PAH. Learn more at aerovatetx.com or follow the Company on X (formerly known as Twitter) and LinkedIn.