BioVie Inc Stock News

Statistically significant benefits observed in bezisterim-treated Long COVID patients  in pre-specified subgroups with high baseline fatigue, cognitive impairment, and/or post‑exertional malaise

BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) told investors that it is preparing to advance its Phase 3 development program for bezisterim in Parkinson's disease and has requested an End-of-Phase 2 meeting with the US Food and Drug Administration. The company is working with Parkinson's disease clinical development experts to finalize the design of a Phase 3 trial.

Company Corresponded with the FDA on an End of Phase 2 Meeting to Align on Phase 3 trial Design for Evaluation of Bezisterim in Early-stage Parkinson's Disease Company Corresponded with the FDA on an End of Phase 2 Meeting to Align on Phase 3 trial Design for Evaluation of Bezisterim in Early-stage Parkinson's Disease

BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) announced that has completed the last on-treatment visit in its Phase 2 ADDRESS-LC clinical trial evaluating bezisterim in adults with Long COVID, with topline results targeted for release before the end of September 2026. The Carson City, Nevada-based clinical-stage company is developing therapies for neurological and neurodegenerative diseases.

CARSON CITY, Nev., Aug. 31, 2026 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for neurological and neurodegenerative diseases, today announced that the last on-treatment visit of its ADDRESS-LC Phase 2 trial evaluating bezisterim for the treatment of neurological symptoms of Long COVID has been completed.

For years, the hunt for a Parkinson's disease-modifying drug came down to one protein: alpha-synuclein. Clear it out, the thinking went, and you slow the disease.

BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) said its drug candidate bezisterim met the prespecified endpoints of a Phase 2 trial in early-stage Parkinson's disease, with patients showing improvements in blood-based inflammatory markers and a range of clinical outcomes compared with placebo. The SUNRISE-PD trial was a multicenter, randomized, double-blind, placebo-controlled study in patients with ea...

Patients treated with bezisterim demonstrated statistically significant improvements compared to placebo on both motor and non-motor symptoms, as assessed by MDS-UPDRS 1 Parts I, II, and III, as well as a composite endpoint comprising 15 clinically relevant measures. Bezisterim treatment appeared to have a beneficial impact on plasma biomarkers of neurodegeneration and reduced biomarkers of bot...