Biovie Inc Stock Price, News & Analysis

BioVie Inc. (NASDAQ: BIVI) has announced alignment with the FDA for its SUNRISE-PD trial to evaluate bezisterim (NE3107) in Parkinson's disease. The trial will assess the drug's effect on motor and non-motor symptoms in approximately 60 patients naive to carbidopa/levodopa. The FDA recommended including the MDS-UPDRS Part II score as a primary endpoint, which is already part of the trial design as a secondary endpoint. BioVie plans to initiate patient screening in Q4 2024. This Phase 2 study aims to explore bezisterim's impact on newly diagnosed patients, complementing earlier trials and potentially establishing its applicability for the entire Parkinson's patient population.

BioVie Inc. (NASDAQ: BIVI) has announced the implementation of a 1-for-10 reverse stock split of its issued and outstanding Class A common stock, effective August 6, 2024. The company's shares began trading on a split-adjusted basis on the same day, maintaining its listing on The Nasdaq Capital Market under the symbol "BIVI". This action follows the approval by BioVie stockholders at a Special Meeting held on July 29, 2024. The reverse split aims to adjust the company's share structure, potentially impacting its market capitalization and share price. Investors can find detailed information about the Special Meeting in the company's definitive proxy statement filed with the SEC on June 17, 2024, available on the SEC website and BioVie's corporate website.

BioVie (Nasdaq:BIVI) and bioAffinity Technologies (Nasdaq:BIAF) will appear on the RedChip Small Stocks, Big Money show on Bloomberg TV on July 6 at 7 p.m. ET. Cuong Do, President and CEO of BioVie, will discuss their late-stage clinical programs for neurodegeneration and liver disease. BioVie's lead asset, bezisterim, has shown promise in treating Parkinson's and Alzheimer's diseases by reducing inflammation, improving motor control, cognition, and brain imaging. BioVie plans to launch a Phase 2b trial for Parkinson's in Fall 2024 and a Phase 3 trial for Alzheimer's in mid-2025.

Maria Zannes, President and CEO of bioAffinity Technologies, will provide a corporate update, highlighting CyPath Lung's success in early-stage lung cancer detection. The test has demonstrated high sensitivity and specificity, with commercialization already underway. The lung cancer screening market is projected to hit $5.7 billion by 2030. bioAffinity's AI-enhanced flow cytometry platform is also being developed for COPD and asthma diagnosis. The company holds extensive patents and is backed by strong insider ownership (39%).

BioVie presented the upcoming SUNRISE-PD Phase 2 trial design at ATMRD 2024, evaluating bezisterim (NE3107) on motor and non-motor symptoms in early Parkinson's disease patients. The trial will involve 60 participants, randomized to receive either bezisterim or placebo for 12 weeks. Key objectives include assessing motor symptom improvements, non-motor symptoms, and overall PD symptoms. In parallel, they presented Phase 2a data showing bezisterim's potential as an adjunctive therapy to carbidopa/levodopa, with significant improvements in motor functions and non-motor symptoms like sleep and restlessness. These findings support further evaluation in a larger trial. If successful, participants may join a future long-term safety study.

BioVie and Mobilicom will be featured on the RedChip Small Stocks, Big Money™ show on Bloomberg TV, airing June 22 at 7 p.m. ET. BioVie's CEO, Cuong Do, discusses the company's late-stage clinical programs targeting neurodegeneration and liver disease, highlighting their lead asset, bezisterim, which has shown promising results in clinical trials for Parkinson's and Alzheimer's diseases. Key milestones include a Phase 2b trial for Parkinson's in Fall 2024 and a Phase 3 trial for Alzheimer's in mid-2025.

Mobilicom's CEO, Oren Elkayam, will talk about their investment opportunities. Mobilicom's products, like SkyHopper Datalinks and the ICE Cybersecurity Suite, have led to significant market penetration, with 50 customers in 18 countries. The company achieved 43% revenue growth and a 59% gross margin in 2023, ending the year with $8.4 million in cash, indicating a solid financial position to execute their strategic plans.

BioVie announced two poster presentations at the ATMRD Congress in Washington, D.C., from June 21-25, 2024. The presentations will focus on the Phase 2 trial protocol for bezisterim (NE3107) in early Parkinson’s patients and its impact on motor and non-motor symptoms, specifically for those not yet treated with carbidopa/levodopa. The first poster will be displayed on June 22 from 5-5:30 p.m. EDT, outlining the study protocol. Another poster will be shown the same day from 4:20-4:50 p.m. EDT, featuring data on bezisterim’s effects when used alongside carbidopa/levodopa.

BioVie (NASDAQ: BIVI), a clinical-stage company focused on neurological, neurodegenerative, and liver diseases, will host a live investor webinar on June 26, 2024, at 4:15 p.m. ET. The event, hosted by RedChip Companies, will feature CEO Cuong Do, discussing the company's clinical pipeline, including bezisterim (formerly NE3107). Bezisterim has shown promising results in reducing inflammation, insulin resistance, and improving symptoms in Parkinson's and Alzheimer's diseases. Strategic priorities include a Phase 2b trial for Parkinson's in Fall 2024, a Phase 3 trial for Alzheimer's in mid-2025, and ongoing partnering discussions.

BioVie announced the formation of an Advisory Board to guide the Phase 2b trial of bezisterim for long COVID, funded by a $499,200 award from the U.S. Department of Defense. The board includes experts from UCSF and Northwestern Feinberg School of Medicine, and industry veterans.

The trial aims to evaluate bezisterim, an anti-inflammatory and insulin-sensitizer, for reducing neurocognitive symptoms in long COVID patients. The trial, involving 200 patients, will assess safety and efficacy over three months.

The Department of Defense may provide an additional $12.6 million upon successful completion of the planning phase and meeting specific milestones.

BioVie announced promising results from a Phase 2a trial of their drug bezisterim for Parkinson's disease. Data presented at the XXIX World Congress on Parkinson's Disease and Related Disorders showed that patients treated with bezisterim in combination with levodopa/carbidopa experienced significant improvements in both motor and non-motor symptoms compared to placebo. Notably, bezisterim-treated patients saw a -2.8 point improvement on the motor section of the MDS-UPDRS scale. For patients under 70, the improvement was -4.7 points. Additionally, bezisterim-treated patients showed significant gains in sleep/fatigue and leg restlessness symptoms. These findings suggest bezisterim's potential as an adjunct therapy, warranting further investigation in late-phase trials.