BioVie Inc. (BIVI) To Present Phase 2 Long COVID Data at NIH Workshop

What happened

BioVie will present Phase 2 ADDRESS-LC data on bezisterim at the NIH RECOVER-TLC workshop, showing subgroup benefits and a safety profile similar to placebo, while the overall intent-to-treat population did not achieve statistical significance.

Confirmed

Global impact / market context

The trial missed its main goal, so the company cannot yet claim broad efficacy, which means proof of benefit is uncertain. Subgroup signals could shape a later Phase 3 trial, and a placebo-like safety profile may reduce concerns about tolerability.

Analyst inference

This is early, signal-finding data that gains visibility through an NIH-backed forum. The DoW grant funding the study is non-dilutive money, which means it eases near-term cash needs without selling shares, supporting the Long COVID program.

Analyst inference

What to watch

1. BioVie presents at the NIH RECOVER-TLC workshop on November 4–5, a high-visibility forum that may influence how investors and potential partners view the Long COVID program. Confirmed
2. The company could design a larger Phase 3 trial with enriched enrollment, meaning selecting patients more likely to respond, and prespecified endpoints to test statistical significance. Proposed
3. Watch whether subgroup benefit in severe fatigue, post-exertional malaise (PEM, symptom worsening after activity), or cognitive deficit holds up, since that would support advancing the program. Analyst inference

Evidence

• globenewswire.com