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BioVie advances Parkinson’s Phase 3 trial plans after positive Phase 2 results and FDA engagement.

Market News
08 Sep 2026
Proactive Investors
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Bullish
BioVie advances Parkinson’s Phase 3 trial plans after positive Phase 2 results and FDA engagement.

BioVie Inc is preparing to advance its Phase 3 clinical trial for bezisterim, a drug targeting Parkinson’s disease, following promising Phase 2 results. The company has requested an End-of-Phase 2 meeting with the FDA to finalize the Phase 3 trial design, focusing on motor symptoms as the primary endpoint and non-motor symptoms as a co-primary or secondary endpoint. Phase 2 data showed potential benefits especially in patients with higher inflammation levels. BioVie aims to discuss trial details with the FDA later this fall and expects formal feedback by the end of 2026. The drug is also being tested for Long COVID and Alzheimer’s disease.

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