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Fierce Biotech·14h ago·2 min read
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BioVie’s stock sinks 50% as company uses composite endpoint to make case for Parkinson’s program

BioVie has hailed phase 2 data as evidence that bezisterim could represent a “meaningful advance” in the treatment of Parkinson’s disease. But the biotech focused on a new composite measure, rather than its stated primary endpoint, and emphasized outcomes in a subpopulation of patients.

Aug 6, 2026·read at Fierce Biotech ↗

Biotech BioVie’s stock sinks 50% as company uses composite endpoint to make case for Parkinson’s program By Nick Paul Taylor Aug 6, 2026 9:40am Parkinson's disease Parkinson's drug Biotech Clinical Data BioVie has hailed phase 2 data as evidence that bezisterim could represent a “meaningful advance” in the treatment of Parkinson’s disease. But investors wiped off half the value of the company's stock as the biotech focused on a new composite measure, rather than its stated primary endpoint. The primary endpoint of the mid-stage study was meant to be change from baseline in part three of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), according to the federal trials database.

That part of the scale evaluates motor signs of Parkinson’s. At an event back in October 2025, BioVie CEO Cuong Do said the company’s goal for the trial was to show bezisterim can help “slow the progression of muscle loss.” BioVie’s press release this morning lacks data on bezisterim’s effect on MDS-UPDRS Part III. However, the biotech included (PDF) data on the endpoint in its updated presentation, alongside results for five other measures of the disease.

The MDS-UPDRS Part III chart shows the placebo-adjusted effect of bezisterim on the motor scale across different baseline platelet counts, an inflammation biomarker. Placebo performed numerically better than bezisterim at lower baseline platelet counts while bezisterim beat placebo numerically in patients with higher counts, although the upper boundary of the 95% confidence interval remained above zero. BioVie put data from the Early Parkinson’s Neuro-Inflammatory Composite 15 (EPNIC-15) at the center of its press release and presentation.

There appears to be little information about this endpoint measure online beyond articles written by BioVie itself. EPNIC-15 was “constructed based on learnings” from a 2025 paper on composite scales for assessing the effects of Parkinson’s drugs, according to BioVie's release this morning. Biohaven researchers coauthored the paper, which makes no mention of EPNIC-15 or inflammatory aspects of Parkinson’s.

BioVie’s composite scale comprises 15 subdomains from UPDRS Part I, Part II, Part III and the Parkinson's Disease Sleep Scale 2. The composite scale includes a subset of measures—speech, toe tapping right, toe tapping left, leg agility left, posture and rest-tremor constancy—from the health indicators evaluated (PDF) in MDS-UPDRS Part III. The results “provide a strong foundation” for continued clinical development of bezisterim, Do said in a statement.

Most patients receiving the drug candidate improved on EPNIC-15 while their counterparts on placebo worsened. BioVie saw the greatest improvement in people with higher levels of inflammation at baseline, as indicated by their platelet count. These results didn't appear to be enough to appease investors, who sent shares in BioVie down 50% to $1 in the first 30 minutes of trading on Thursday, from a Wednesday closing price of $2.01.

The company published the clinical trial results alongside a filing to offer stock at an assumed price of $1.33 a share. Parkinson's disease Parkinson's drug Biotech Clinical Data

source

Reporting by Fierce Biotech.

read at Fierce Biotech ↗
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companies & drugs in this story

drugs
bezisterim8Parkinson's Disease4
topics
Parkinson's Disease4Neurology

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