BioVie released topline results from the Phase 2 ADDRESS-LC trial of bezisterim for Long COVID, showing statistically significant improvements in pre-specified high-symptom-burden subgroups across multiple endpoints.

In the overall intent-to-treat population, bezisterim favored placebo on most endpoints but did not achieve statistical significance.

About 78% of the roughly 200-patient study were in pre-specified subgroups based on baseline fatigue, post-exertional malaise, or objective cognitive impairment, as outlined in a statistical analysis plan submitted to the FDA before unblinding.

The press release carries forward-looking statements and risk disclosures, along with contact information for investor relations and media inquiries.

The report includes related stock context, listing tickers, and performance data alongside the news.

BioVie remains unprofitable with no revenue; its market cap around $17 million means earnings-based metrics like P/E are not meaningful and P/S is largely undefined due to no sales.

Market reaction noted in accompanying data; the stock fell after the announcement as results are described as exploratory for informing future trials.

Readouts are not yet publicly disclosed in full; investors can monitor ClinicalTrials.gov for updates and top-line results when released.

The study was fully funded by a $13.13 million DoD PRMRP award, and results were presented ahead of a conference call.

BioVie will hold a conference call at 8:30 a.m. Eastern on September 15, 2026, to discuss results with management and host a live Q&A.

If warranted by the results, BioVie plans to move forward with a confirmatory Phase 3 trial for bezisterim in Long COVID.

Guest speakers for the event include Michael Peluso, MD, and Ezra Spier, with a live Q&A and replay available on BioVie's site.