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BioVie Inc. reported topline results from its Phase 2 SUNRISE-PD trial of oral bezisterim in early-stage Parkinson’s disease patients who had not received carbidopa/levodopa. The multicenter, randomized, double-blind, placebo-controlled study met prespecified endpoints focused on inflammatory biomarkers and exploratory clinical outcomes.
Patients treated with bezisterim showed statistically significant improvements versus placebo on motor and non-motor symptoms measured by MDS-UPDRS Parts I–III and the EPNIC-15 composite, as well as broad shifts in proteomic and neuroinflammatory biomarkers. Biomarker and proteomic endpoints are described as exploratory, and bezisterim’s potential impact on disease progression will require confirmation in future trials, including a potentially pivotal Phase 3 study. Bezisterim was reported to be well tolerated with an adverse event profile comparable to placebo. BioVie plans a conference call on August 12, 2026, to discuss the results.
BioVie Inc. filed a shelf registration to offer up to $300,000,000 of securities, including Class A common stock, preferred stock, warrants, debt securities, rights and units. The shelf permits multiple offerings in one or more transactions with terms to be provided in prospectus supplements.
The prospectus states Nasdaq listing under the symbol BIVI, a June 11, 2026 closing price of $1.66, and an aggregate market value of common stock held by non-affiliates of $12,542,929 as of June 8, 2026 (based on 7,292,401 non-affiliate shares at $1.72 per share). Net proceeds are intended for working capital and general corporate purposes.