BioVie could offer first new Parkinson’s therapy in decades

In biotech, the most compelling investment stories often emerge where medical need, scientific differentiation, and timing intersect. BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW), a clinical-stage biopharmaceutical company with a market capitalization still measured in the tens of millions, is attempting exactly that by targeting what it believes is a root driver of neurodegeneration rather than merely treating symptoms.

At the center of BioVie’s strategy is bezisterim (NE3107), an oral small-molecule drug designed to block TNF alpha mediated inflammation and reverse insulin resistance. The company is advancing the compound across multiple central nervous system indications, but Parkinson’s disease has now emerged as the lead value driver.

Parkinson’s disease affects roughly one million people in the United States alone, with prevalence expected to rise steadily as populations age. Despite decades of research, Parkinson’s treatment has changed little. Levodopa, the gold standard for over 50 years, addresses dopamine deficiency but does not slow neurodegeneration and can cause debilitating involuntary movements.

BioVie’s thesis is that Parkinson’s symptoms only emerge when two conditions coexist: low dopamine levels and chronic inflammation driven insulin resistance in the brain. While dopamine replacement treats the former, no approved therapy meaningfully addresses the latter.

“Right now, the only drugs that are out there are symptomatic relief,” CEO Cuong Do told Proactive. “It relieves the symptoms of Parkinson's, the shaky, the loss of muscle control and so forth… whereas we believe bezisterim may have a chance at actually addressing the underlying driver of the disease.”

Earlier intervention could be transformative, according to Do. “If you can slow the underlying driver, of course, you can slow the disease, you slow the symptoms.”

Previous Phase 2 studies combining bezisterim with levodopa showed clinically meaningful benefits, including improved motor control, improved “morning on” symptoms, and signals of reduced levodopa-induced dyskinesia in animal models. Those data laid the groundwork for BioVie’s current focus on testing bezisterim as a standalone therapy earlier in the disease course.

BioVie has now completed enrollment in SUNRISE-PD, a mid-stage Phase 2 trial evaluating bezisterim in 60 early-stage Parkinson’s patients who have not yet begun levodopa therapy. The trial is designed to determine whether bezisterim alone can delay motor decline, which would meaningfully differentiate it from existing treatments.

“We're now conducting a trial to establish the second half, using bezisterim alone with earlier Parkinson’s patients who are starting therapy for the first time,” Do said. “We hope to show that bezisterim alone can delay the loss of muscle control.”

Topline data from SUNRISE-PD are expected in April or May 2026, placing the company firmly in a catalyst window that many biotech investors look for.

While Parkinson’s is the lead program, bezisterim’s mechanism has broader implications. The drug is also being studied in long COVID and Alzheimer’s disease, both conditions where chronic inflammation is increasingly implicated.

In long COVID, BioVie is running a 200-patient trial supported by a $13 million non-dilutive grant.

Separately, BioVie is advancing BIV201, a second clinical asset targeting ascites associated with late-stage liver disease. A Phase 2 trial was terminated early after demonstrating more than a 50 percent reduction in fluid buildup, which was an ethically driven decision given the high mortality rate of the condition. The program now has FDA clearance to proceed directly into a single Phase 3 study under orphan and fast-track designations.

“We believe BIV201 has the potential to become the first therapy for that condition,” Do said.

Despite this breadth of clinical activity, BioVie’s valuation remains modest. Management believes the disconnect reflects both market skepticism toward early-stage biotech and a lack of appreciation for the company’s near-term data flow.

“I think this is a great time for investors who have a 12-month planning horizon or investment horizon,” Do said. “We have a terrific portfolio that has multiple drugs in development, multiple catalysts, multiple shots on goal.”

For investors, BioVie represents a classic high-risk, high-reward setup: a differentiated scientific thesis, human efficacy signals, and multiple binary catalysts approaching within the next 12 to 18 months.

2026 will be a big catalyst year for the company, Do said.

In a sector where meaningful upside often hinges on a single successful trial, BioVie’s bet is that targeting inflammation at the source rather than chasing symptoms could finally move the needle in Parkinson’s disease. If the data cooperate, the market may not ignore it for long.