Why Is Alzheimer's/Parkinson's Focused BioVie Stock Surging On Friday?

BioVie Inc BIVI shares are trading higher after the drug developer announced two upcoming presentations at the International Conference on Alzheimer’s and Parkinson’s Diseases 2024.

The Carson City, Nevada-based company’s stock is trading on a session volume of 8.96 million compared to an average volume of 536.8K, as per data from Benzinga Pro.

Improvements in non-motor symptoms correlated with improvements in motor symptoms for Parkinson’s Disease patients.

• Data from phase 2a placebo-controlled study suggest improvements in NE3107-treated patients with non-motor symptoms. 
• NE3107-treated patients experienced a significant improvement of -2.4 points for the sleep/fatigue domain of the Non-Motor Symptom Scale (NMSS) in Parkinson’s Disease, whereas placebo patients experienced a worsening of +1.0 points (p=0.0159). 
• Sleep/fatigue domain improvements correlated with motor score improvements. 
• More patients on NE3107 had improvements in the NMSS sleep/fatigue domain, while more patients on placebo worsened.
• NMSS changes for NE3107-treated patients were driven by improvements of -0.87 in fatigue/lack of energy and improvement of -2.91 on the urge to move legs/restlessness in legs. 
• Placebo patients saw no significant change of -0.39 on fatigue (p=0.1242) and -0.71 on leg restlessness (p=0.5141).
• Furthermore, 26% of NE3107-treated patients experienced an improvement in their ability to move, having Part 3 scores before their first-morning dose of carbidopa/levodopa that were equal to or better than Part 3 scores associated with their being in the “on” state after carbidopa/levodopa treatment at the start of the study, whereas none of the placebo patients had the similarly improved morning Part 3 scores. The difference was statistically significant (p=0.046).

Clinical outcomes from a Phase 3 trial of NE3107 in mild to moderate probable Alzheimer’s disease reconfirm topline cognitive and functional data previously presented and will provide additional biomarker data and analyses.

• The NM101 trial enrolled 439 patients through 39 sites. The company previously reported that upon trial completion, significant deviation from protocol and Good Clinical Practice violations caused the company to exclude all patients from these sites. 
• Due to the exclusion of data from many sites, the trial missed statistical significance but showed promising directional data on cognitive and functional measures. 
• NE3107-treated patients saw an advantage compared to placebo of -0.95 (68% slowing of decline) on CDR-SB, -0.94 (26%) on ADAS-COG-12, -0.43 (139%) on ADAS-CGIC, -0.03 (27%) on ADCOMS, +1.02 (40%) on MMSE, and +3.08 (47%) on ADCS-ADL.

Price Action: BIVI shares are up 176.7% at $3.45 during the premarket session on the last check Friday.

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