BioVie seeks FDA end-of-Phase 2 meeting to advance bezisterim Phase 3 Parkinson’s trial design

• BioVie opened the next stage of FDA engagement to advance a Phase 3 program for bezisterim in Parkinson’s disease.
• Phase 3 design centers on improving motor symptoms, with non-motor symptom benefit positioned as a key co-primary or secondary outcome.
• Earlier Phase 2 results have already been presented, suggesting stronger overall symptom improvement in patients with higher inflammation.
• The strategy could support a Phase 3 study of about 175 patients, using an enrichment approach to target likely responders.
• BioVie expects FDA discussion later this fall, with formal written feedback anticipated before year-end.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioVie Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202609080730PRIMZONEFULLFEED9822169) on September 08, 2026, and is solely responsible for the information contained therein.