BioVie Shares Plunge After Long COVID Drug Fails Phase 2 Trial

Shares of BioVie Inc. plunged in pre-market trading Tuesday after the clinical-stage biotechnology company announced its Phase 2 trial for a Long COVID treatment failed to meet its primary goals.

Trial Fails to Meet Primary Endpoints

The ADDRESS-LC trial, which evaluated the drug bezisterim for neurological symptoms associated with Long COVID, did not achieve statistical significance on any of its 22 clinical outcome measures in the full intent-to-treat population of 203 patients, the company reported. The data release was a closely watched catalyst for investors, with the company having previously guided for topline results by the end of September 2026.

For a clinical-stage company with no approved products, a failure to meet the main objectives of a study is a significant setback that often triggers a sharp negative reaction from the market.

Subgroup Analysis Offers Nuance

Despite the primary endpoint miss, BioVie's announcement highlighted some positive signals from a pre-specified subgroup analysis. According to the company, the trial demonstrated statistically significant improvements in patients who entered the study with a higher burden of symptoms.

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Key details from the subgroup include:

• This cohort represented approximately 78% of the total trial participants.
• BioVie also noted that 21 of the 22 endpoints showed numerical trends that favored bezisterim over the placebo, even if they did not meet the threshold for statistical significance across the entire study group.

Market Reaction and Macro Headwinds

The market reacted swiftly to the headline failure, sending BioVie stock down nearly 9.7% in pre-open trading. The sell-off was exacerbated by a risk-averse broader market, with the Federal Reserve beginning a two-day policy meeting and the 10-year Treasury yield recently trading above 5%, which tends to compress valuations for speculative equities.

Investors will be closely monitoring the company's conference call for management's commentary on a potential path forward. The company's ability to frame the subgroup data as a basis for a more targeted Phase 3 trial design will be critical in shaping the stock's performance.