Why Is Small Cap-Heart Disease Focused Aerovate Therapeutics Stock Plummeting On Monday?

Monday, Aerovate Therapeutics Inc AVTE released topline results from the Phase 2b portion of the IMPAHCT Phase 2b/3 trial of AV-101, a dry powder inhaled formulation of imatinib, for pulmonary arterial hypertension (PAH).

Aerovate Therapeutics shares are trading lower on a session volume of 4.8 million versus an average volume of 213.43K, as per data from Benzinga Pro.

Developed specifically for pulmonary arterial hypertension, AV-101 targets cellular hyperproliferation and resistance to apoptosis, driven by improper signaling in cells of the distal pulmonary arteries.

AV-101 is designed for delivery by an easy-to-use dry powder inhaler directly into the lungs to maximize potential clinical benefit and limit systemic adverse effects.

The primary endpoint for the Phase 2b portion of IMPAHCT is a change in pulmonary vascular resistance (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).

The company has also reviewed data from several additional secondary endpoints of the Phase 2b portion of IMPAHCT, which also failed to show meaningful improvements.

Based on these results, Aerovate, in agreement with the independent study advisory committee, is halting enrollment and shutting down the Phase 3 portion of IMPAHCT and the long-term extension study.

Aerovate plans to release full data from the Phase 2b portion of IMPAHCT later, the timing of which is to be determined.

As of June 15, 2024, Aerovate has approximately $100 million in cash, cash equivalents, and short-term investments.

Price Action: AVTE shares are down 90.6% at $2.32 at last check Monday.

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