BioVie, Inc. filings document a Nevada clinical-stage biopharmaceutical company with Nasdaq-listed Class A common stock and, in certain filings, warrants tied to its capital structure. Material-event reports cover securities offerings, underwriting agreements and issuances involving units, pre-funded units and warrants.
Proxy statements and related 8-K filings describe annual meeting voting matters, director elections, board appointments and amendments to the company’s omnibus equity incentive plan. Registration statement amendments provide formal disclosure for offering activity and financial-statement periods associated with BioVie’s development-stage operations.
BioVie Inc. is a clinical-stage biopharma focused on neurological disorders and advanced liver disease. Lead asset bezisterim (NE3107) targets inflammation-driven insulin resistance in Parkinson’s, Alzheimer’s and long COVID, supported by a broad patent estate and multiple pending applications.
In 2026 the 57-patient Phase 2b SUNRISE-PD trial in early Parkinson’s met its prespecified pharmacodynamic primary endpoint, showing a statistically significant improvement in a composite neuroinflammation biomarker measure versus placebo, and favorable trends on a 15‑item clinical composite, with a safety profile comparable to placebo. A Phase 2 long COVID trial is fully enrolled, funded by a $13.1 million U.S. Department of War grant, with topline data expected in late summer 2026. An earlier Alzheimer’s Phase 3 study was undermined by major protocol and cGCP violations at 15 sites, leaving the trial underpowered after excluding affected patients.
In liver disease, BIV201 (continuous-infusion terlipressin) has FDA Fast Track and Orphan Drug designations. A 15‑patient Phase 2 study in refractory ascites suggested a 53% reduction in ascites volume during treatment versus pre‑treatment, supporting an FDA‑guided Phase 3 design. BioVie has no approved products, no revenue, significant accumulated losses, dependence on future financings, concentrated cash balances above insured limits, and faces an active securities class action and related derivative litigation, all contributing to substantial doubt about its ability to continue as a going concern.
Morgan Stanley and Morgan Stanley Smith Barney LLC report beneficial ownership of Class A common stock of BioVie Inc. They disclose aggregate beneficial ownership of 896,822 shares, representing 11.9% of the class.
The reporting persons state they have no sole voting or dispositive power, but report shared dispositive power over 896,822 shares. The Schedule 13G/A is filed on behalf of Morgan Stanley as a parent holding company and Morgan Stanley Smith Barney LLC as a broker-dealer and investment adviser, with additional details for relevant subsidiaries referenced in an exhibit.
Morgan Stanley and its subsidiary Morgan Stanley Smith Barney LLC reported beneficial ownership of 605,472 shares of BioVie Inc. Class A common stock, representing 8.0% of the class as of June 30, 2026. Both entities list 0 shares with sole voting or dispositive power. They report 1 share with shared voting power and 605,472 shares with shared dispositive power, indicating these shares are controlled jointly within Morgan Stanley’s reporting units. The filing clarifies that it reflects only securities held by specified Morgan Stanley operating units and excludes positions disaggregated under SEC Release No. 34-39538.
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.