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) presented exploratory biomarker findings from its Phase 2 ADDRESS-LC trial linking two Long COVID biological subgroups to different bezisterim responses. The trial randomized 203 participants to bezisterim or placebo for 12 weeks; no overall-population efficacy outcome reached statistical significance.
Among 67 participants with high inflammation, Week 12 objective global cognition showed a treatment-associated effect of approximately 0.83 on a standardized effect-size measure (p=0.001). Among 44 participants with low white-blood-cell/myeloid levels, fatigue and post-exertional malaise effects were approximately 0.80–0.90 (p≈0.11). Neuropeptide Y relative abundance was approximately 33% lower with treatment at Week 12 across the analyzed population. Treatment-emergent adverse events occurred in 41.6% of bezisterim recipients versus 55.9% with placebo. BioVie said the preliminary findings may inform future trial design.
BioVie (NASDAQ: BIVI) entered into a securities purchase agreement for an offering expected to raise approximately $4.74 million in gross proceeds. A single healthcare-focused institutional investor will purchase 2,962,500 common shares or common stock equivalents at $1.60 each in a registered direct offering priced at-the-market under Nasdaq rules.
A concurrent private placement includes unregistered warrants to purchase up to 2,962,500 shares at an exercise price of $1.70 per share. The warrants become exercisable six months after issuance and expire five and a half years from issuance. Gross proceeds are before placement agent commissions and other offering expenses. BioVie expects closing on or about November 5, 2026, subject to customary closing conditions, and intends to use net proceeds for working capital and general corporate purposes.
BioVie (NASDAQ: BIVI) will present bezisterim Long COVID data at a late-breaking oral session on November 13, 2026, in Nice, France. The presentation at the 4th Long COVID International Conference will include previously unshared biomarker data from the Phase 2 ADDRESS-LC trial.
The randomized, placebo-controlled exploratory study showed a trend toward improvement across most efficacy measures. Prespecified exploratory analyses found statistically significant improvements on multiple measures in patients with greater baseline symptom burden. Approximately 78% of participants had more severe fatigue, post-exertional malaise or objective cognitive impairment in at least one domain. A $13.13 million U.S. Department of War award fully funds the study.
BioVie (NASDAQ: BIVI) will present Phase 2 bezisterim results for Long COVID at the RECOVER-TLC workshop on November 5, 2026. Dr. Penelope Markham will discuss the ADDRESS-LC trial at the event in Bethesda, Maryland.
BioVie reported a consistent trend toward improvement versus placebo across most efficacy measures. Participants with greater baseline fatigue, post-exertional malaise or cognitive impairment experienced the greatest benefits, including statistically significant improvements on multiple measures corresponding to their most pronounced symptoms. Safety and tolerability were similar to placebo. The trial enrolled approximately 200 patients and evaluated 22 clinical outcome measures, with no single endpoint pre-specified as the primary determinant of success.
BioVie (BIVI) presented Phase 2 SUNRISE-PD results for investigational bezisterim in early Parkinson’s disease at the American Neurological Association meeting. The randomized, placebo-controlled trial enrolled 57 patients and tested treatment for 12 weeks. In a prespecified subgroup with baseline platelet counts above 230 × 10⁹/L, representing approximately half the trial population, motor, non-motor and total symptom scores improved significantly versus placebo.
In the overall modified intent-to-treat population, the Composite Benefit Score, a measure combining multiple disease domains, favored bezisterim (p=0.0004). Clinically meaningful improvement occurred in 25% versus 4% with placebo; meaningful worsening occurred in 14% versus 46%. Treatment-emergent adverse events occurred in 39.3% versus 51.7%, with no severe or serious adverse events in either group.
BioVie (NASDAQ: BIVI) presented Phase 2 bezisterim results showing statistically significant improvements in Long COVID patients with higher baseline symptom burden. The randomized, placebo-controlled ADDRESS-LC trial treated 203 patients for 12 weeks and explored 22 measures, with no single primary endpoint. The overall population showed trends toward improvement; statistically significant findings were reported in higher-burden subgroups.
Among the most fatigued half, fatigue scores improved 8.93 points versus 5.30 with placebo at Week 12 (p=0.02). Higher baseline post-exertional malaise or cognitive impairment also identified subgroups with significant cognitive benefits. Treatment-emergent adverse events occurred in 41.6% versus 55.9%; no serious events occurred with bezisterim versus one with placebo. BioVie believes the findings support confirmatory Phase 3 study design. A $13.13 million U.S. Department of War award fully funds the study.
BioVie (BIVI) will present results from two Phase 2 bezisterim trials at the American Neurological Association meeting, October 17–20, 2026.
The ADDRESS-LC Long COVID poster is scheduled for October 18, and the SUNRISE-PD Parkinson’s disease poster for October 19 in San Diego. SUNRISE-PD enrolled 57 patients with early-stage disease who had not previously received carbidopa/levodopa. Topline results showed improvements in inflammation biomarkers and greater improvements than placebo across measures of daily functioning, motor symptoms and non-motor symptoms. ADDRESS-LC enrolled approximately 200 patients to evaluate brain fog, fatigue and other chronic neurological symptoms. Bezisterim remains investigational.
BioVie (BIVI) reported topline Phase 2 ADDRESS‑LC results for bezisterim in Long COVID, showing statistically significant benefits in pre‑specified subgroups with high baseline fatigue, cognitive impairment and/or post‑exertional malaise (PEM).
The 203‑patient randomized, double‑blind, placebo‑controlled trial tested 22 clinical endpoints without a single primary endpoint. In the overall intent‑to‑treat population, 21 of 22 endpoints numerically favored bezisterim, but none reached statistical significance, which the company links to many patients having low baseline symptom burden. In pre‑specified high‑burden subgroups, effect sizes more than doubled and multiple clinically related endpoints achieved statistical significance across fatigue, PEM and objective cognitive measures, though these findings are exploratory and require confirmation in a prospective Phase 3 trial.
Bezisterim’s safety and tolerability were similar to placebo, with fewer treatment‑emergent adverse events and no serious adverse events in the bezisterim arm. The study is fully funded by a $13.13 million U.S. Department of War award.
BioVie (BIVI) will host a conference call and webcast on September 15, 2026 at 8:30 a.m. ET to discuss topline data from its Phase 2 ADDRESS-LC trial of investigational oral drug bezisterim in adults with Long COVID–related cognitive impairment and fatigue.
The randomized, placebo-controlled, multicenter proof‑of‑concept study evaluates efficacy, safety and tolerability across 22 clinical outcome measures, including cognitive function, fatigue, sleep disturbance, Quality of Life and post‑exertional malaise. Guest speakers include investigator Michael Peluso, MD, MHS, and Long COVID patient advocate Ezra Spier, followed by a live Q&A with BioVie management. A replay will be available on the company’s website.
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.