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BioVie Faces Mixed Phase 2 Results for Bezisterim in Long COVID

Sep 15, 2026, 12:45 PM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Initial reaction was a sharp decline despite some positive subgroup signals; lack of ITT significance creates fundamental uncertainty and valuation risk, likely pressuring shares in the near term.

AI summary

What happened, with direct paths to the underlying reporting

BioVie disclosed topline Phase 2 ADDRESS-LC data for bezisterim in Long COVID. Pre-specified subgroup analyses showed meaningful improvements in patients with high symptom burden, while the overall ITT trend was not statistically significant; safety remained favorable. The company also advances its Parkinson’s program, but confirmatory data from a prospective trial remains necessary, keeping clinical and regulatory risk elevated.

Phase 2 ADDRESS-LC: subgroup analyses show improvements in high-symptom patients; ITT not significant.
203-patient Phase 2; 21 of 22 ITT endpoints trend favorable; pre-specified subgroups doubled effects.
Favorable safety; adverse events 41.6% vs 55.9%; headaches mild, no serious AEs.
Parkinson’s program: SUNRISE-PD showed inflammation-linked MDS-UPDRS improvements in treated patients.
Stock down 16% to $1.72 on topline results.

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BioVie Faces Mixed Phase 2 Results for Bezisterim in Long COVID

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