BioVie Inc. BIVI
BioVie Inc. (Nasdaq: BIVI) is a CNS/neurology/psychiatry drug developer. Its lead program, Bezisterim (NE3107), is in Phase 2 for Parkinson's disease. Its next catalyst on record is BIV201: Finalize Phase 3 design and endpoints with FDA (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: BIV201 — Finalize Phase 3 design and endpoints with FDA (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Bezisterim (NE3107) | Alzheimer's disease | small molecule | Phase 3 |
| BIV201 (terlipressin) | Ascites due to liver cirrhosis | protein/peptide | Phase 3 |
| Bezisterim (NE3107) | Parkinson's disease (SUNRISE-PD, NCT06757010) | small molecule | Phase 2 |
| Bezisterim (NE3107) | Long COVID | small molecule | Phase 2 |
Recent results and decisions
- Aug 6, 2026positive Phase 2b SUNRISE-PD (n=57) reported statistically significant improvement vs placebo on MDS-UPDRS Parts I-III and a 15-measure composite; nominal, unadjusted p-values, exploratory; AEs 39.3% vs 51.7%.
Patients treated with bezisterim demonstrated statistically significant improvements compared to placebo on both motor and non-motor symptoms, as assessed by MDS-UPDRS1 Parts I, II, and III, as well as a composite endpoint comprising 15 clinically relevant measures.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.