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BioVie, Inc. develops clinical-stage drug therapies for neurological and neurodegenerative diseases and advanced liver disease. Company news centers on bezisterim, also known as NE3107, an investigational oral small molecule studied in Parkinson’s disease, Alzheimer’s disease and Long COVID through its effects on neuroinflammation and insulin sensitivity.
Recurring updates include clinical-study enrollment and results planning, scientific-conference abstracts, key opinion leader events and investor presentations. BioVie also reports on BIV201, its orphan drug candidate for refractory ascites associated with liver cirrhosis, alongside corporate communications about pipeline progress and financing activity.
BioVie (BIVI) is advancing its Phase 3 development program of bezisterim for early-stage Parkinson’s disease following correspondence with the FDA on an End-of-Phase 2 meeting to align on trial design.
The company is working with Parkinson’s experts to finalize a Phase 3 trial using MDS‑UPDRS Part III (motor symptoms) as the primary endpoint, with MDS‑UPDRS Part I (non‑motor symptoms) planned as a co‑primary or secondary endpoint. Phase 2 SUNRISE‑PD data in 57 early-stage, levodopa‑naïve patients showed that bezisterim‑treated patients with elevated inflammatory markers, measured by platelet levels, achieved statistically significant differences versus placebo across MDS‑UPDRS Parts I, II, III, and total score in exploratory analyses. BioVie plans an enrichment strategy focusing on patients with higher inflammation, which it believes could support a Phase 3 trial of approximately 175 patients.
The company has requested an End‑of‑Phase 2 meeting and anticipates formal written FDA feedback on the proposed Phase 3 design before year‑end.
BioVie (NASDAQ: BIVI) announced completion of the last on-treatment on-site visit in its Phase 2 ADDRESS-LC trial of bezisterim (NE3107) for neurological symptoms of Long COVID, with topline data targeted for release before the end of September 2026. The randomized, placebo-controlled, multicenter study, which enrolled approximately 200 adults with cognitive impairment and fatigue related to Long COVID, is fully funded by a $13.13 million grant from the U.S. Department of War through the Peer-Reviewed Medical Research Program.
The trial evaluates 20 mg oral bezisterim twice daily versus placebo on overall clinical benefit, cognitive function, fatigue, sleep disturbance, Quality of Life and post-exertional malaise. Bezisterim, an oral, blood-brain-barrier-penetrant anti-inflammatory and insulin-sensitizing agent, has previously shown biomarker and clinical improvements in a Parkinson’s disease study and encouraging preliminary data in Alzheimer’s disease trials.
BioVie (NASDAQ: BIVI) reported topline Phase 2b SUNRISE-PD results for bezisterim in 57 early-stage, levodopa‑naïve Parkinson’s disease patients. The 12‑week, randomized, double‑blind, placebo‑controlled trial met its prespecified pharmacodynamic and clinical objectives, showing improvements in blood-based inflammatory markers and multiple clinical endpoints.
Bezisterim‑treated patients showed statistically significant advantages over placebo on the EPNIC‑15 composite (‑0.04 vs +0.18; p=0.0006) and MDS‑UPDRS Parts I–III, with strongest effects in patients with higher baseline platelet counts. Extensive biomarker data indicated reduced neuro- and systemic inflammation, proteomic shifts in 283 of 380 proteins toward lower inflammatory burden, and exploratory signals of reduced neuronal injury (e.g., composite neuronal injury signal ‑0.09 vs +0.06; p=0.043; NfL slope difference p=0.008). Safety was comparable to placebo, with similar adverse event rates and no severe or serious events reported. BioVie plans a conference call on August 12, 2026, and intends to use these findings to inform a potentially registrational Phase 3 trial.
BioVie (NASDAQ:BIVI), a clinical-stage biopharma focused on neurological and neurodegenerative diseases, will host a live investor webinar on June 2, 2026 at 4:15 p.m. ET.
Management will discuss bezisterim (NE3107), late-stage drug candidate BIV201, clinical progress, safety data, and upcoming milestones, followed by a Q&A session.
BioVie (NASDAQ:BIVI) announced full enrollment of its ADDRESS-LC Phase 2 trial of bezisterim for neurological symptoms of Long COVID. The study is fully funded by a U.S. Department of War grant, with topline data targeted for late summer 2026.
ADDRESS-LC evaluates bezisterim’s proposed modulation of inflammatory pathways linked to neurocognitive and neuropsychiatric Long COVID symptoms such as fatigue, cognitive dysfunction, post-exertional malaise and sleep disturbance. There are currently no FDA-approved treatments for Long COVID.
BioVie (NASDAQ:BIVI) completed the last patient evaluation visit in its SUNRISE-PD Phase 2 trial of bezisterim in early-stage Parkinson’s disease, with topline data targeted for Q3 2026.
The study aims to evaluate motor and non-motor outcomes and inform Phase 3 registrational trial design.
BioVie (NASDAQ: BIVI) will host a virtual Key Opinion Leader event on May 7, 2026 at 2:00 PM ET to discuss bezisterim (NE3107) and the company’s Phase 2 study in Parkinson's disease ahead of topline data due in 2Q26.
The session features Suzanne de la Monte, MD, MPH, and company management, with a live Q&A. The event will review bezisterim’s mechanism of action and its preclinical and early clinical signals on inflammation and insulin resistance related to Parkinson’s pathology.
BioVie (NASDAQ: BIVI) announced that an abstract from its SUNRISE-PD study of bezisterim (NE3107) in early Parkinson’s disease was accepted for presentation at the American Academy of Neurology Annual Meeting in Chicago, April 18–22, 2026.
The poster, titled "A Study of NE3107 (Bezisterim) in Early Parkinson's Disease (SUNRISE-PD): Baseline Demographics and Characteristic," will be presented on Monday, April 20, 5:00–6:00 PM CT. Topline results from SUNRISE-PD are expected in mid‑2026. The AAN represents 44,000+ neurology professionals.
BioVie (NASDAQ: BIVI) announced an abstract acceptance for a poster presentation from its SUNRISE-PD study of bezisterim (NE3107) in early Parkinson’s disease at AD/PD 2026, March 17-21 in Copenhagen.
The poster, “Demographics and Baseline Characteristics of Participants in a Study of Bezisterim (SUNRISE-PD),” summarizes initial enrolled-patient data. Topline results are expected in mid-2026.
BioVie (NASDAQ: BIVI) will host an exclusive investor webinar on March 4, 2026 at 4:15 p.m. ET and a live Q&A with CEO Cuong Do. The presentation will review investigational drug bezisterim (NE3107) and orphan candidate BIV201, clinical progress, safety signals, and development plans.
Registration is free via RedChip and questions may be pre-submitted to BIVI@redchip.com or asked live.