Terlipressin Acetate

BioVie disclosed in 2024 that it was halting work on BIV201.\n BioVie is eyeing a $19.7 million IPO for a spinout focused on bringing a new formulation of an approved kidney failure drug to market as a potential treatment for liver disease.The plan is to offer 1.8 million shares of the spinout, called Option Therapeutics, priced between $10 and $12 apiece, according to a March 13 Securities and Exchange Commission (SEC) filing. Should the final price come in at the middle of this range, BioVie expects Option to rake in $17 million in net proceeds for the IPO—rising to $19.7 million if underwriters fully take up their option to buy an additional 272,727 shares at the same price.After the IPO—for which a date has yet to be set—BioVie will still own at least 60% of Option, meaning the company has the final say in electing Option’s directors.Option will be focused on taking forward an investigational infusion treatment called BIV201. The vasopressin V1 receptor agonist is made of terlipressin acetate, an injectable form of which is marketed by Mallinckrodt Pharmaceuticals under the name Terlivaz to improve kidney function for adults with hepatorenal syndrome. BioVie had previously been evaluating BIV201 for ascites, a common complication of liver cirrhosis. There are currently no approved treatments specifically for the condition.With about 190,000 patients hospitalized each year in the U.S. with cirrhosis and ascites, BioVie has estimated that the potential market for BIV201 could top $2.3 billion. But, despite having labeled BIV201 its “most de-risked program,” BioVie disclosed in 2024 that it was halting work on the asset, explaining that “unfortunately [it] is a program that will take two years to complete.”At the time, BioVie CEO Cuong Do said the biotech “look[ed] forward to partnering this program with a company interested in developing the first potential treatment for ascites and related complications potentially at an earlier stage of cirrhosis.” Now, it’s been decided that the vehicle to take BIV201 forward will be Option. In Friday’s SEC filing, BioVie reaffirmed that it had already received clearance from the FDA to begin a phase 3 study in adults with decompensated liver cirrhosis and ascites who have recently recovered from, or are recovering from, acute kidney injury. The only thing delaying Option is sourcing the necessary funds.After a lull of biotech IPOs in 2025, Option could soon be joining a growing list of drug developers voicing an interest in the public markets. CEOs of companies that already made the leap this year told Fierce they had detected a positive change in sentiment toward biotech IPOs in recent months.

CARSON CITY, Nev., March 12, 2026 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for neurological and neurodegenerative diseases, today announced the acceptance of an abstract from its SUNRISE-PD study on lead candidate bezisterim (NE3107) in the treatment of patients with Parkinson’s Disease at the upcoming AD/PD 2026 Advances in Science & Therapy annual meeting, to be held March 17-21, 2026 in Copenhagen, Denmark. The abstract, titled Demographics and Baseline Characteristics of Participants in a Study of Bezisterim (NE3107) in Early Parkinson’s Disease (SUNRISE-PD) (J. Palumbo 1 , C Ahlem1, C.L. Reading 1 , S. O’Quinn 2 , J. Zhang 3 , M. Stacy 4 ), summarizes the initial data on patients enrolled in the SUNRISE-PD study, and will be presented as a poster. Topline results from the SUNRISE-PD study are expected in mid‑2026. The AD/PD™ Alzheimer’s Disease and Parkinson’s Disease Conference will present all the latest breakthroughs in treatment, translational R&D, early diagnosis, drug development, and clinical trials in Alzheimer’s, Parkinson’s, and other related neurological disorders. Affiliations: 1 BioVie, Inc, 2 Perissos, Inc., 3 Princeton Pharmatech, 4 Medical University of South Carolina About Bezisterim Bezisterim (NE3107) is an oral drug that crosses the blood-brain barrier and works to reduce inflammation and improve insulin sensitivity without suppressing the immune system and with a low risk of drug-drug interactions. By modulating key pathways involved in neuroinflammation (ERK, NFκB, TNF-α), bezisterim may have therapeutic potential in several disease indications, including Parkinson’s disease, Long COVID, and Alzheimer’s disease. In Parkinson’s disease, BioVie has already completed a Phase 2 study that showed patients with moderate-to severe Parkinson’s taking bezisterim with levodopa had better motor control and fewer morning symptoms compared to those taking levodopa alone. Few drug-related side effects were observed. The current SUNRISE-PD just completed enrolling 60 patients to evaluate whether bezisterim alone can help improve motor and non-motor symptoms for Parkinson’s patients who have not been treated with carbidopa/levodopa. Topline results are expected in mid‑2026. For Long COVID, the ADDRESS-LC trial is enrolling about 200 patient to evaluate if bezisterim can reduce brain fog, fatigue, and other lingering neurological symptoms associated with Long Covid, which are believed to be triggered by persistent circulation of spike protein fragments that trigger inflammation via NFκB activation (which bezisterim has been shown to modulate). Topline data is expected mid-2026. In Alzheimer’s disease, BioVie has conducted both Phase 2 and Phase 3 trials. Early results suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy for the six million Americans living with Alzheimer’s. About BioVie Inc. BioVie Inc. (NASDAQ: BIVI) is a clinical-stage biopharmaceutical company focused on developing therapies for neurological disorders and advanced liver disease. Its lead candidate, bezisterim (NE3107), targets neuroinflammation and insulin resistance, which are believed to be key drivers of Alzheimer’s and Parkinson’s disease. Bezisterim is also being studied for long COVID, where persistent inflammation is thought to underlie symptoms such as brain fog and fatigue. In liver disease, BioVie is advancing BIV201, a continuous infusion of terlipressin treatment that has received FDA Orphan and Fast Track designations. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, and the Company plans to study BIV201 in a Phase 3 trial for the reduction of further decompensation in patients with cirrhosis and ascites. For more information, visit . For Investor Relations Inquiries: For Media Inquiries: Contact: Chuck Padala Managing Director, LifeSci Advisors, LLC chuck@lifesciadvisors.com Contact: Melyssa Weible Managing Partner, Elixir Health Public Relations mweible@elixirhealthpr.com