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BIVI

BIVI US Stock
$13.5
Open: $13.352 High: $14.24 Low: $13.01 Close: $13.5
Range: 2021-05-06 - 2021-05-07
Volume: 61,850
Market: Closed
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BIVI
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BIVI News
Latest news about the BIVI
  • BioVie to Present at 2021 B. Riley Securities’ Neuroscience Conference

    SANTA MONICA, Calif., April 28, 2021 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) ("BioVie" or "Company"), a clinical-stage company developing innovative drug therapies for the treatment of liver disease and, pending closing of the announced transaction with NeurMedix, neurological and neuro-degenerative disorders and certain cancers, today announced the participation of its President and Chief Executive Officer Cuong Do at the 2021 B. Riley Securities’ Neuroscience Conference. Mr. Do is scheduled to present on Wednesday, April 28 at 3:00 PM Eastern Time and will discuss BioVie’s pending acquisition of NeurMedix’s assets and plans going forward for Alzheimer’s and Parkinson’s. BioVie Presentation Details Date: Wednesday, April 28, 2021 Time: 3:00 PM Eastern Time A live webcast of BioVie’s presentation will be available [Here] and a replay will be available for a period of one year. Also, on Thursday, April 29, 2021 at 8:00 AM, B. Riley will host a KOL Discussion where the role of neuroinflammation in Alzheimer’s will be discussed titled: Forgetting the “Past” So that We Can Remember the “Now”: Deep Dive on Next-Gen, Mid-Stage Candidates for Alzheimer’s Disease. Dr. Alan A. Mazurek, Icahn School of Medicine at Mount Sinai; Dr. Martin J. Sadowski, NYU School of Medicine. This scientific discussion is relevant to the Company’s promising new drug candidate, NE3107, that is designed to reduce neuroinflammation in Alzheimer’s disease. About BioVie, Inc. BioVie Inc. (“BioVie”) is a clinical-stage biopharmaceutical company that engages in developing products for the treatment of liver disease and, pending closing of the announced transaction with NeurMedix, neurological and neuro-degenerative disorders and certain cancers. The company’s lead clinical drug candidate to be acquired from NeurMedix, NE3107, has successfully completed 11 pre-clinical, and 6 Phase 1, Phase 1/2, and Phase 2 clinical studies in various inflammatory diseases indicating its broad potential to inhibit inflammatory cascade without evidence of immunosuppression. In addition to Alzheimer’s Disease, BioVie plans to enter clinical trials for the treatment of Parkinson’s Disease and several oncological indications. The Company is focused on diseases with significant unmet medical needs and commercial potential in order to expedite FDA review, minimize capital requirements and optimize shareholder value. BioVie is also developing BIV201 (continuous infusion terlipressin) an Orphan drug candidate for the treatment of ascites due to advanced liver cirrhosis. First-to-market Orphan therapies typically receive 7 years of market exclusivity in the US for the designated use. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis, and future development opportunities include hepatorenal syndrome (HRS) and other life-threatening complications. The Company recently initiated patient screening in its second US Phase 2 clinical trial, and upon completion will commence a pivotal Phase 3 trial shortly thereafter. The trial design is summarized on www.clinicaltrials.gov, trial identifier NCT04112199. The FDA has never approved any drug specifically for treating ascites, and the Company is not aware of any competing drugs in late-stage development for ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. For more information, visit http://www.biovieinc.com/. CONTACTS: INVESTOR RELATIONS:Bruce MackleManaging DirectorLifeSci Advisors, LLCbmackle@lifesciadvisors.com

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  • BioVie Acquires Biopharma Assets from Privately Held NeurMedix

    Includes Pivotal Phase 3 Alzheimer’s Asset NE3107 Cuong V. Do Named CEO of The New BioVie Conference Call Scheduled for April 27, 2021 at 5:00PM EDT SANTA MONICA, Calif., April 27, 2021 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) ("BioVie" or "Company"), a clinical-stage company developing innovative drug therapies for chronic debilitating liver diseases, today announced the acquisition of the biopharmaceutical assets of NeurMedix, Inc., (NeurMedix), a San Diego based privately held clinical-stage pharmaceutical company focused on novel therapeutic assets for the treatment of neurodegenerative and neurological disorders, as well as certain cancers. Under the terms of the agreement, BioVie will pay to NeurMedix consideration consisting of 8,361,308 newly issued BioVie shares and approximately $3.0 million cash at closing, an additional $7.3 million cash payment after all contemplated clinical programs have been funded and a pivotal Phase 3 clinical trial for NuerMedix’ lead drug candidate, NE3107, has met its primary endpoints, and additional shares over time as various significant clinical, regulatory, and commercial milestones are met, as detailed below. The transaction is expected to close in June 2021. The transaction transforms BioVie’s pipeline by expanding its focus into several compelling therapeutic areas with high unmet medical needs. NeurMedix’s lead clinical drug candidate, NE3107, 17α-ethynyl-androst-5-ene-3b,7b,17b-triol, is a first-in-class small molecule, orally administered, highly effective inhibitor of insulin resistance and the pathological inflammatory cascade and with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance play fundamental roles in the development of Alzheimer’s and Parkinson’s Disease. NE3107 uniquely inhibits neuroinflammation and insulin resistance in the brain, which is different from insulin resistance in the periphery. Consequently, NE3107 could represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from Alzheimer’s and 1 million from Parkinson’s. This unique molecule has demonstrated a wide safety margin, absence of immunosuppression and the ability to cross the blood-brain barrier in pre-clinical and Phase 2 clinical trials. In February, NeurMedix announced authorization by the U.S. Food & Drug Administration to initiate its pivotal Phase 3, randomized, double‑blind, placebo‑controlled, parallel group, multicenter study of NE3107 in subjects who have mild to moderate Alzheimer’s Disease (NCT04669028). This trial will include 316 adult patients with expected initiation mid-2021 and expected primary completion in 2H 2022. In addition to Alzheimer’s Disease, BioVie will endeavor to advance NE3107 in a range of other diseases where insulin resistance and inflammation is implicated, including Parkinson’s, multiple myeloma and prostate cancer in the coming year. Concurrent with the assets acquisition, BioVie announced the appointment of Cuong V. Do as President and CEO, effective immediately. Commenting on the announcement, Terren Peizer, Chairman of BioVie said, “We believe this is a transformative transaction for BioVie. With it, BioVie has acquired an attractive portfolio of agents with broad therapeutic potential in Alzheimer’s Disease, Parkinson’s Disease, several oncology indications and potentially many other areas. Combined with BioVie’s lead candidate BIV201 in development for the treatment of advanced liver diseases, we expect to have two molecules entering pivotal Phase 3 studies in the coming year. The company’s pipeline is now focused on several attractive areas of unmet medical need with significant market potential. With the appointment of a proven leader and strategic thinker like Cuong Do as President & CEO, who brings over 30 years of industry experience, we are confident in our ability to fully realize this significant commercial opportunity.” Mr. Do is a veteran biotech and pharmaceutical entrepreneur, having previously founded Callidus Biopharma (sold to Amicus Therapeutics), Lysodel Therapeutics and M6P Therapeutics. Previously, Mr. Do was President, Global Strategy Group at Samsung, where he helped create the strategy for Samsung’s biologics business. Prior to Samsung, he was the Chief Strategy Officer for Merck where he helped focused the company’s portfolio and its future on oncology. He was also a former senior partner at McKinsey & Company, where he spent 17 years and helped build the healthcare, high-tech and corporate finance practices. “NeurMedix’s lead asset NE3107 is one of the most exciting inhibitors of the pathological inflammatory cascade I have seen,” said Mr. Do. “Research done to date indicates that this is a highly-targeted small molecule that crosses the blood-brain barrier with an excellent safety-profile. NE3107 blocks insulin resistance and neuroinflammation at the right time and place, without inhibiting homeostatic activity. This asset has extremely broad potential, and I look forward to working with the highly talented NeurMedix clinical team to advance these assets.” Under the terms of the agreement, BioVie has agreed to pay the following consideration to the shareholders of NeurMedix: Payments at closing 8,361,308 million newly issued BioVie sharesApproximately $3.0 million in cash An additional $7.3 million cash payment payable after all contemplated clinical programs have been funded and a pivotal Phase clinical trial for NeurMedix’s Alzheimer’s drug candidate has met its primary endpointContingent payments in additional BioVie shares (capped at 90% ownership) upon achievement of significant milestones $350 million upon hitting endpoints in pivotal trials$700 million upon FDA acceptance of NDA filing$1,200 million upon FDA approval of NDA$750 million upon achieving $1.0 billion trailing 12-month net sales Conference Call BioVie will host a conference call today April 27, 2021 at 5:00PM ET to discuss the transaction and the company’s forward-looking plans. The webcast link below can be used to access the event both live and via replay. Conference Call & Webcast DetailsDomestic: 877-451-6152International: 201-389-0879Conference ID: 13719347Webcast: http://public.viavid.com/index.php?id=144714 Advisors Moelis & Co. is acting as exclusive financial advisor to BioVie. Hogan Lovells is serving as legal counsel to BioVie, and Greenberg Traurig is serving as legal counsel to NeurMedix. The Weinstein Group advised BioVie in the scientific diligence of the NeurMedix assets and clinical trial plans. About NeurMedix, Inc. NeurMedix, Inc. is a clinical-stage biopharmaceutical company that engages in developing products for the treatment of neurological and neuro-degenerative disorders and certain cancers. The company’s new drug candidate has successfully completed 11 pre-clinical, and 6 Phase 1, Phase 1/2, and Phase 2 clinical studies in various inflammatory diseases indicating its broad effect in inhibiting inflammatory cascade without evidence of immunosuppression. In addition to Alzheimer’s Disease, NeurMedix plans to enter clinical trials for the treatment of Parkinson’s Disease and several oncological indications. The company’s focus is on diseases with significant unmet medical needs and commercial potential in order to expedite FDA review, minimize capital requirements and optimize shareholder value. About BioVie’s Liver Cirrhosis Program BioVie Inc. is developing BIV201 (continuous infusion terlipressin) an Orphan drug candidate for the treatment of ascites due to advanced liver cirrhosis. First-to-market Orphan therapies typically receive 7 years of market exclusivity in the US for the designated use. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis, and future development opportunities include hepatorenal syndrome (HRS) and other life-threatening complications. The Company recently initiated patient screening in its second US Phase 2 clinical trial, and upon completion will commence a pivotal Phase 3 trial shortly thereafter. The trial design is summarized on www.clinicaltrials.gov, trial identifier NCT04112199. The FDA has never approved any drug specifically for treating ascites, and the Company is not aware of any competing drugs in late-stage development for ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. For more information, visit http://www.biovieinc.com/. Forward-Looking Statements This press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our clinical trials and to obtain approval for our product candidates, to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law. Contact: INVESTOR RELATIONS:Bruce MackleManaging DirectorLifeSci Advisors, LLCbmackle@lifesciadvisors.com

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  • BioVie to Present at 31st Annual Oppenheimer Healthcare Conference

    SANTA MONICA, Calif., March 11, 2021 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) ("BioVie" or "Company"), a clinical-stage company developing innovative drug therapies for liver disease, today announced the participation of its management team in the 31st Annual Oppenheimer Healthcare Conference. Terren Peizer, Chairman and Chief Executive Officer of BioVie, and Jonathan Adams, President and Chief Operating Officer, will present an overview of the company and its lead candidate BIV201 (continuous infusion terlipressin) for the treatment of ascites due to advanced liver cirrhosis. Mr. Peizer and Mr. Adams are scheduled to present on Thursday March 18, 2021 at 8:40AM Eastern Time. A live webcast of BioVie’s presentation will be available at: https://wsw.com/webcast/oppenheimer9/bivi/2710290 and a replay will be available for a period of 90 days. About BioVie and BIV201 BioVie Inc. is developing BIV201 (continuous infusion terlipressin) an Orphan drug candidate for the treatment of ascites due to advanced liver cirrhosis. First-to-market Orphan therapies typically receive 7 years of market exclusivity in the US for the designated use. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis, and future development opportunities include hepatorenal syndrome (HRS) and other life-threatening complications. The Company plans to begin patient enrollment in its second US Phase 2 clinical trial in early 2021, and upon completion will commence a pivotal Phase 3 trial shortly thereafter. The trial design is summarized on www.clinicaltrials.gov, trial identifier NCT04112199. The FDA has never approved any drug specifically for treating ascites, and the Company is not aware of any competing drugs in late-stage development for ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The Company has invented a patent-pending prefilled syringe that has been cleared by the FDA for use in our upcoming Phase 2 trial. This novel BIV201 delivery system is expected to greatly simplify at-home patient treatment and improve patient compliance by enabling easy injection of the liquid concentrate into the IV bag connected to the infusion pump. Room temperature stability has been achieved for 12 months providing an important advantage because, to the best of the Company's knowledge, all other terlipressin products sold globally must be stored under refrigeration. The novel prefilled syringe format also avoids the manual mixing of minute (2 – 4 mg) quantities of terlipressin powder in saline solution, thereby reducing the possibility of dosing errors during reconstitution and improving sterility. BioVie has begun applying for global patent protection for this novel terlipressin delivery system. The Company has also received Orphan Drug designation for the treatment of hepatorenal syndrome (HRS) and has FDA Fast Track status. For more information, visit http://www.biovieinc.com/. Forward-Looking Statements This press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our clinical trials and to obtain approval for our product candidates, to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law. Contact: INVESTOR RELATIONS:Bruce Mackle Managing Director LifeSci Advisors, LLC bmackle@lifesciadvisors.com

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  • BioVie Commences Patient Screening in Phase 2 Clinical Trial

    SANTA MONICA, Calif., March 09, 2021 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) ("BioVie" or "Company"), a clinical-stage company developing innovative drug therapies for liver disease, today announced the start of patient screening in the Company’s Phase 2 Trial of BIV201 (continuous infusion terlipressin) for the treatment of refractory ascites. The trial—A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients with Cirrhosis and Refractory Ascites—will be initiated at nine prestigious research centers in the U.S. One center has recently been activated and has begun screening patients. The company expects to activate additional centers over the next several weeks. Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid in the abdomen, often exceeding 5 liters, due to liver and kidney dysfunction. The FDA has never approved a drug to treat ascites, and once patients reach the refractory stage the estimated one-year survival rate is only approximately 50% (Bureau et al. 2017). BIV201 is a continuous infusion of terlipressin, a drug used in over 40 countries to treat related complications of liver cirrhosis that has not been approved in the US or Japan. With a novel prefilled syringe format that is stable at room temperature, BIV201 could potentially provide a superior terlipressin drug delivery system throughout the world. BioVie previously conducted a Phase 2a trial of continuous infusion terlipressin in this patient population at a Veterans Administration hospital. The pharmacokinetics of terlipressin following continuous infusion generated in this study determined for the first time that administration of terlipressin as a continuous infusion avoids high, potentially harmful, peak blood concentrations associated with intermittent IV bolus dosing. The study also supported that the drug was well tolerated overall and that it was feasible to administer terlipressin by continuous infusion in an outpatient setting. The current trial will evaluate the efficacy of BIV201 in addition to standard-of-care (SOC) compared to SOC alone for the treatment of refractory ascites. Terlipressin will be administered with a continuous low dose infusion administered via a portable pump in two 28-day treatment cycles. The primary endpoints are the incidence of complications of at least Grade 2 severity, and the change in cumulative ascites in the 12-week period following randomization compared to a 12-week pre-treatment period. The BIV201 trial plans to enroll 30 patients to be treated in the home care setting. “With no approved treatments and a poor one-year survival we believe there is a clear unmet medical need for an effective drug treatment for patients suffering from refractory ascites,” said Terren Peizer, chairman and chief executive officer of BioVie. “Interest from the research community has been strong, which we believe speaks to the need for new therapies for this Orphan drug indication. Many of our trial sites have affiliated paracentesis clinics that treat large numbers of ascites patients on a regular basis, and we expect enrollment to commence and accelerate in the coming weeks.” About BioVie and BIV201 BioVie Inc. is developing BIV201 (continuous infusion terlipressin) an Orphan drug candidate for the treatment of ascites due to advanced liver cirrhosis. First-to-market Orphan therapies typically receive 7 years of market exclusivity in the US for the designated use. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis, and future development opportunities include hepatorenal syndrome (HRS) and other life-threatening complications. The Company plans to commence patient enrollment in its second US Phase 2 clinical trial in early 2021, and upon completion will commence a pivotal Phase 3 trial shortly thereafter. The trial design is summarized on www.clinicaltrials.gov, trial identifier NCT04112199. The FDA has never approved any drug specifically for treating ascites, and the Company is not aware of any competing drugs in late-stage development for ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The Company has invented a patent-pending prefilled syringe that has been cleared by the FDA for use in our upcoming Phase 2 trial. This novel BIV201 delivery system is expected to greatly simplify at-home patient treatment and improve patient compliance by enabling easy injection of the liquid concentrate into the IV bag connected to the infusion pump. Room temperature stability has been achieved for 12 months providing an important advantage because, to the best of the Company's knowledge, all other terlipressin products sold globally must be stored under refrigeration. The novel prefilled syringe format also avoids the manual mixing of minute (2 – 4 mg) quantities of terlipressin powder in saline solution, thereby reducing the possibility of dosing errors during reconstitution and improving sterility. BioVie has begun applying for global patent protection for this novel terlipressin delivery system. The Company has also received orphan drug designation for the treatment of hepatorenal syndrome (HRS) and has FDA Fast Track status. For more information, visit http://www.biovieinc.com/. Forward-Looking Statements This press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our clinical trials and to obtain approval for our product candidates, to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law. Contact: Bruce Mackle Managing Director LifeSci Advisors, LLC bmackle@lifesciadvisors.com

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  • BioVie Interview to Air on Bloomberg TV in the US on the RedChip Money Report®

    SANTA MONICA, Calif., Feb. 19, 2021 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) ("BioVie" or "Company"), a clinical-stage company developing innovative drug therapies for liver disease, today announced an interview with Terren Peizer, Chairman and Chief Executive Officer, will air on The RedChip Money Report® on Bloomberg TV in the US on Saturday, February 20, at 7 p.m. local time in 73M homes across the United States. The RedChip Money Report® also airs on Bloomberg International in Europe in 100M homes at 6 pm local time on Sundays. In the exclusive interview, Peizer discusses the Company’s development of BIV201, an orphan drug candidate for the treatment of ascites due to advanced liver cirrhosis. Also discussed is the global market opportunity and upcoming clinical trial milestones. To view the interview segment, please visit: https://youtu.be/u7G2l36rwn8 “The RedChip Money Report" delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, financial book reviews, as well as featured interviews with executives of public companies. About BioVie and BIV201BioVie Inc. is developing BIV201 (continuous infusion terlipressin) an Orphan Drug candidate for the treatment of ascites due to advanced liver cirrhosis. First-to-market Orphan therapies typically receive 7 years of market exclusivity in the US for the designated use. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis, and future development opportunities include hepatorenal syndrome (HRS) and other life-threatening complications. The Company plans to commence patient enrollment in its second US Phase 2 clinical trial in the first quarter of 2021. The trial design is summarized on www.clinicaltrials.gov, trial identifier NCT04112199. The FDA has never approved any drug specifically for treating ascites, and the Company is not aware of any competing drugs in late-stage development for ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The Company has invented a patent-pending prefilled syringe that has been cleared by the FDA for use in our upcoming Phase 2 trial. This novel BIV201 delivery system is expected to greatly simplify at-home patient treatment and improve patient compliance by enabling easy injection of the liquid concentrate into the IV bag connected to the infusion pump. Room temperature stability has been achieved for 12 months providing an important advantage because, to the best of the Company's knowledge, all other terlipressin products sold globally must be stored under refrigeration. The novel prefilled syringe format also avoids the manual mixing of minute (2 – 4 mg) quantities of terlipressin powder in saline solution, thereby reducing the possibility of dosing errors during reconstitution and improving sterility. BioVie has begun applying for global patent protection for this novel terlipressin delivery system. The Company has also received Orphan Drug designation for the treatment of hepatorenal syndrome (HRS) and has FDA Fast Track status. For more information, visit http://www.biovieinc.com/. Forward-Looking StatementsThis press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our clinical trials and to obtain approval for our product candidates, to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law. Contact: INVESTOR RELATIONS:Dave Gentry, CEORedChip Companies Inc.407-491-4498dave@redchip.com

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  • NeurMedix Obtains FDA Authorization for Pivotal Phase 3 Alzheimer’s Trial

    NeurMedix Expects to Enroll the First Patient in May 2021SAN DIEGO, Feb. 02, 2021 (GLOBE NEWSWIRE) -- NeurMedix, LLC, a San Diego based privately held clinical stage pharmaceutical company announced that it has received authorization from the U.S. Food and Drug Administration’s (FDA) Office of Neuroscience, Division of Neurology I, to initiate a pivotal phase 3 clinical trial in Alzheimer’s disease with its lead clinical drug candidate, NE3107, 17α-ethynyl-androst-5-ene-3,7,17-triol. NE3107 is a small molecule, orally administered, anti-inflammatory, insulin-sensitizing agent with a novel mechanism of action. The clinical trial, a Phase 3, randomized, double-blind, placebo-controlled, parallel group, multicenter study of NE3107 in subjects who have mild to moderate Alzheimer’s disease (NCT04669028) will be conducted at approximately thirty clinical sites in the U.S. The trial will evaluate twice daily 20 mg oral NE3107 versus placebo for 30 weeks beginning with dose titration of 5 mg BID in weeks 1 and 2 and 10 mg BID in weeks 3-4, with 20 mg BID for weeks 5-30. Approximately 316 patients will be randomized with a 1:1 ratio of active to placebo. Inclusion/exclusion criteria are structured to help select only AD patients and exclude subjects with cognitive impairment secondary to other medical conditions. Stable regime of approved AD co-medication is permitted, and continued use of glycemic control medications stable for three months prior to randomization is permitted. The co-primary endpoints are mean change from baseline to week 30 in ADAS-Cog 12 comparing the NE3107 group to the placebo group, and mean change from baseline to week 30 in ADCS-CGIC comparing the NE3107 group to the placebo group. Secondary endpoints include additional tests of neuropsychological deficits, measures of glycemic control, and inflammation. The rationale for the trial is based on growing scientific evidence linking inflammation and insulin resistance to Alzheimer’s disease dementia and progression. The recently coined term, “type 3 diabetes,” underscores the close link between Alzheimer’s disease and insulin resistance that develops from inflammatory inactivation of the insulin signaling pathway in the brains of Alzheimer’s patients. Inflammation has long been known as a major driver of Alzheimer’s disease, but currently approved anti-inflammatory agents, and potentially those in development, are poorly suited to chronic use in Alzheimer’s due to one or more factors relating to poor blood-brain barrier penetration, toxicity and side effects, or mechanisms of action that are too narrow to be effective against the multiplicity of inflammatory pathways that are activated in the disease. NE3107 addresses these issues as a highly blood brain barrier permeable drug, with very low potential for toxicity that targets the major inflammation signaling pathways, those mediated by extracellular signal regulated kinase (ERK), nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB), and tumor necrosis factor (TNF). The company believes that NE3107’s combination of small molecule characteristics and broad mechanism of action without immunosuppressive effects provides advantages over protein-based TNF inhibiting therapies, as well as antibodies against amyloid beta and phospho-tau. Commenting on the announcement, Terren Peizer, Chairman and CEO, and majority shareholder of NeurMedix and BioVie Inc. (NASDAQ: BIVI), a clinical-stage company developing innovative drug therapies for liver disease, stated, “It is well-known that insulin resistance predicts neuroinflammation, and cognitive decline, and that up to 81% of Alzheimer’s disease patients have impaired glucose tolerance or type 2 diabetes (Diabetes 53 474 2004). We believe NE3107 reduces neuroinflammation and restores insulin sensitivity, and thereby may halt the progression of Alzheimer’s disease. Of the four indications that we hope to pursue in the coming year, we believe that the application of NE3107 to Alzheimer’s disease has a very high probability of success as it uniquely addresses all of the known pathways of Alzheimer’s disease. The FDA’s authorization of this pivotal phase 3 clinical trial is an important milestone in our pursuit of a life changing, safe, and efficacious intervention for this largest unmet medical need. Having followed the evolution of the science, the drug development, and capital investment in excess of $85 Million in NE3107, it’s gratifying for the NeurMedix team to have the opportunity to validate and deliver meaningful benefits to this important patient population.” Christopher Reading PhD, Chief Scientific Officer of NeurMedix, added: “Inflammation-driven systems dysregulation has been well-described in Parkinson’s and Alzheimer’s diseases. It was recently reported in the journal Diabetes Care that increases in coefficients of variation (CVs) of fasting glucose and HbA1c were independently associated with an increased risk of Alzheimer’s disease (Diabetes Care 40 1210 2017), suggesting that our previous findings that NE3107 decreases system dysregulation should bode well for the Phase 3 trial.” The protocol was developed in collaboration with a team from a leading global contract research organization (CRO), Worldwide Clinical Trials (Worldwide), led by Dr. Michael Murphy, MD, PhD, Worldwide’s Chief Medical and Scientific Officer. Dr. Murphy is a widely recognized expert in translational research, strategic program development, and facilitation of commercialization during clinical development, with greater than 30 years of experience in Alzheimer's drug development and clinical trial design. The trial will be managed by Cognitive Research Corporation (CRC, St. Petersburg, FL), a full-service CRO with a proven track record in assessing both the efficacy and safety of products across a wide range of indications, and primarily focused on CNS research in psychiatric and neurologic therapeutic areas. NeurMedix expects to enroll the first patient in May 2021. Previous clinical studies with NE3107 conducted in the FDA Division of Metabolism and Endocrinology Products demonstrated anti-inflammatory and insulin sensitizing activity in subjects with evidence of systemic inflammation. Publication of these results reported that NE3107 increased insulin-stimulated glucose disposal and HDL cholesterol, and decreased C-reactive protein (CRP, a measure of systemic inflammation) in impaired glucose tolerance subjects (Obesity 21 E343 2013). A subsequent publication summarized inflammatory, hematologic and metabolic parameters from placebo-treated subjects with increasing metabolic dysregulation included healthy volunteers, impaired glucose tolerant subjects, dyslipidemia patients, metformin-treated and treatment-naïve type 2 diabetes patients, and described the effects of inflammation on metabolic and hematological homeostasis. The publication reported that inflammation associated with increasing metabolic dysregulation increased the CVs of clinical laboratory tests for inflammatory, hematologic and metabolic parameters, demonstrating inflammation-driven systems dysregulation. In the type 2 diabetes study, advanced type 2 diabetic subjects on placebo showed statistically random effects for erythroid, glucose and HbA1c fluctuations. After 84 days of NE3107 treatment, NE3107 significantly decreased insulin resistance, postprandial glucose and HbA1c in obese, inflamed patients. In addition, NE3107 significantly decreased variances in tests for hyperglycemia (fasting glucose, fructosamine), erythroid (HbA1c), dyslipidemia (triglycerides), endocrine (insulin, leptin), inflammatory (monocyte chemoattractant protein-1 [MCP-1]), and homeostasis (homeostatic model assessment of pancreatic beta cell function [HOMA %B] and insulin resistance [HOMA IR]) parameters, compared to placebo (Mediators Inflamm 2013 814989). The conclusion being that the anti-inflammatory action of NE3107 restored homeostasis to the dysregulated parameters. About NeurMedix, LLC NeurMedix, Inc. is a clinical-stage biopharmaceutical company that engages in developing products for the treatment of neurological and neuro-degenerative disorders and certain cancers. The company’s product candidates have successfully completed 11 pre-clinical, and 6 Phase I, Phase I/II, and Phase II clinical studies in various inflammatory diseases indicating its broad anti-inflammatory effect without evidence of immunosuppression. In addition to Alzheimer’s disease, NeurMedix plans to enter clinical trials for the treatment of Parkinson’s disease and several oncological indications later this year. In excess of $85 million has been invested in developing NE3107. The company’s focus is on diseases with significant unmet medical needs and commercial potential in order to expedite FDA review, minimize capital requirements and optimize shareholder value. Contact:Bruce MackleLifeSci Advisors, LLC(929) 469-3859

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  • BioVie Interview to Air on Bloomberg International on the RedChip Money Report

    SANTA MONICA, Calif., Oct. 30, 2020 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) ("BioVie" or "Company"), a clinical-stage company developing innovative drug therapies for liver disease, today announced an interview with Terren Peizer, Chairman and Chief Executive Officer, will air on The RedChip Money Report television program this Sunday November 1st. The RedChip Money Report airs in 100 million homes on Sundays at 6 p.m. local time in every country in Europe on Bloomberg International. In the exclusive interview, Peizer discusses the Company’s development of BIV201, an orphan drug candidate for the treatment of ascites due to advanced liver cirrhosis, and upcoming milestones.To view the interview segment, please visit: https://youtu.be/xxzTsexijPU.“The RedChip Money Report" delivers insightful commentary on small cap investing, interviews with Wall Street analysts, financial book reviews, as well as featured interviews with executives of public companies.About BioVie and BIV201BioVie Inc. is developing BIV201 (continuous infusion terlipressin) an Orphan Drug candidate for the treatment of ascites due to advanced liver cirrhosis. First-to-market Orphan therapies typically receive 7 years of market exclusivity in the US for the designated use. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis, and future development opportunities include hepatorenal syndrome (HRS) and other life-threatening complications. The Company plans to commence its second US Phase 2 clinical trial by the end of this year. The trial design is summarized on www.clinicaltrials.gov, trial identifier NCT04112199. The FDA has never approved any drug specifically for treating ascites, and the Company is not aware of any competing drugs in late-stage development for ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan.The Company has invented a patent-pending prefilled syringe that has been cleared for use in our upcoming Phase 2 trial subject to certain additional standard analytical tests. This novel BIV201 delivery system is expected to greatly simplify at-home patient treatment and improve patient compliance by enabling easy injection of the liquid concentrate into the IV bag connected to the infusion pump. Room temperature stability has been achieved for 9 months providing an important advantage because, to the best of the Company's knowledge, all other terlipressin products sold globally must be stored under refrigeration. The novel prefilled syringe format also avoids the manual mixing of minute (2 – 4 mg) quantities of terlipressin powder in saline solution, thereby reducing the possibility of dosing errors during reconstitution and improving sterility. BioVie has begun applying for global patent protection for this novel terlipressin delivery system. The Company has also received Orphan Drug designation for the treatment of hepatorenal syndrome (HRS) and has FDA Fast Track status. For more information, visit http://www.biovieinc.com/.Forward-Looking StatementsThis press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our clinical trials and to obtain approval for our product candidates, to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law.Contact:INVESTOR RELATIONS: Dave Gentry, CEO RedChip Companies Inc. 407-491-4498 dave@redchip.com

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  • BioVie to Participate in B. Riley Securities Liver Disease Therapeutics Day on October 29, 2020

    SANTA MONICA, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ:BIVI) ("BioVie" or "Company"), a clinical-stage company developing innovative drug therapies for liver disease, today announced that it will participate in the B. Riley Securities’ Liver Disease Therapeutics Day 2020 on Thursday, October 29, 2020 at 11:00 a.m. ET. BioVie’s Chairman & CEO, Terren Peizer, and Jonathan Adams, President & COO, will participate in Panel 2: Disease-Modifying Therapeutics in Well-Defined Orphan Liver Diseases. They will provide a brief overview of the company, the clinical development program, and US revenue opportunity followed by Q&A. To register for and attend this event, please go to: https://www.webcaster4.com/Webcast/Page/2433/38305About BioVie and BIV201BioVie Inc. is developing BIV201 (continuous infusion terlipressin) an Orphan Drug candidate for the treatment of ascites due to advanced liver cirrhosis. First-to-market Orphan therapies typically receive 7 years of market exclusivity in the US for the designated use. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis, and future development opportunities include hepatorenal syndrome (HRS) and other life-threatening complications. The Company plans to commence its second US Phase 2 clinical trial by the end of this year. The trial design is summarized on www.clinicaltrials.gov, trial identifier NCT04112199. The FDA has never approved any drug specifically for treating ascites, and the Company is not aware of any competing drugs in late-stage development for ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan.BioVie has invented a patent-pending prefilled syringe that has been cleared for use in our upcoming Phase 2 trial subject to certain additional standard analytical tests. This novel BIV201 delivery system is expected to greatly simplify at-home patient treatment and improve patient compliance by enabling easy injection of the liquid concentrate into the IV bag connected to the infusion pump. Room temperature stability has been achieved for 9 months providing an important advantage because, to the best of the Company’s knowledge, all other terlipressin products sold globally must be stored under refrigeration. The novel prefilled syringe format also avoids the manual mixing of minute (2 – 4 mg) quantities of terlipressin powder in saline solution, thereby reducing the possibility of dosing errors during reconstitution and improving sterility. BioVie has begun applying for global patent protection for this novel terlipressin delivery system. The Company has also received Orphan Drug designation for the treatment of hepatorenal syndrome (HRS) and has FDA Fast Track status. For more information, visit http://www.biovieinc.com/Forward-Looking StatementsThis press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company’s ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability consummate additional acquisitions and successfully integrate newly acquired companies, to organically grow our business, to successfully defend potential future litigation, changes in local or national economic conditions, the ability to comply with contractual covenants, including in respect of its debt, as well as various additional risks, many of which are now unknown and generally out of the Company’s control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law.Contact:INVESTOR RELATIONS: Dave Gentry, CEO RedChip Companies Inc. 407-491-4498 dave@redchip.com

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  • BioVie Announces Closing of Public Offering of Common Stock

    Includes Full Exercise of Underwriters’ Overallotment OptionSANTA MONICA, Calif., Sept. 23, 2020 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ:BIVI) ("BioVie" or "Company"), a clinical-stage company developing innovative drug therapies for liver disease, today announced that it has closed its previously announced underwritten public offering of Class A common stock, including the full exercise of the underwriters’ overallotment option, resulting in aggregate gross proceeds to the Company of $18.0 million. The Class A common stock sold in the offering has been approved for listing on the Nasdaq Capital Market under the symbol “BIVI.” After deducting underwriting fees and other offering expenses payable by the Company, the net proceeds to the Company were approximately $15.8 million.The Company intends to use the net proceeds from the offering primarily to fund clinical trials of its lead product candidate BIV201 and for working capital and other general corporate purposes.ThinkEquity, a division of Fordham Financial Management, Inc., and Kingswood Capital Markets, division of Benchmark Investments, Inc. acted as joint book-running managers for the offering.The Securities and Exchange Commission ("SEC") declared effective a registration statement on Form S-1 relating to these securities on September 17, 2020 and an additional registration statement on Form S-1 relating to the offering was filed pursuant to Rule 462(b), which became effective upon filing. A final prospectus relating to this offering has been filed with the Securities and Exchange Commission. The offering has been made only by means of a prospectus. Copies of the prospectus relating to the offering may be obtained by contacting ThinkEquity, 17 State Street, 22nd Floor, New York, NY 10004, telephone (877) 436-3673, email: prospectus@think-equity.com. Investors may also obtain these documents at no cost by visiting the SEC's website at http://www.sec.gov.This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.About BioVie and BIV201BioVie Inc. is developing BIV201 (continuous infusion terlipressin) an Orphan Drug candidate for the treatment of ascites due to advanced liver cirrhosis. First-to-market Orphan therapies typically receive 7 years of market exclusivity in the US for the designated use(s). It is being investigated as a potential new therapy for patients suffering from ascites, and future development opportunities include hepatorenal syndrome (HRS) and other life-threatening complications of advanced liver cirrhosis. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis. The Company has completed a Phase 2 clinical trial protocol that is summarized on www.clinicaltrials.gov, trial identifier NCT04112199. The FDA has never approved any drug specifically for treating ascites, and the Company is not aware of any competing drugs in late-stage development for ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan.The Company has invented a patent-pending prefilled syringe that has been cleared for use in our upcoming Phase 2 trial subject to certain additional standard analytical tests. This novel BIV201 delivery system is expected to greatly simplify at-home patient treatment and improve patient compliance by enabling easy injection of the liquid concentrate into the IV bag connected to the infusion pump. Room temperature stability has been achieved for 9 months providing an important advantage because, to the best of the Company’s knowledge, all other terlipressin products sold globally must be stored under refrigeration. The novel prefilled syringe format also avoids the manual mixing of minute (2 – 4 mg) quantities of terlipressin powder in saline solution, thereby reducing the possibility of dosing errors during reconstitution and improving sterility. BioVie has begun applying for global patent protection for this novel terlipressin delivery system. The Company has also received Orphan Drug designation for the treatment of hepatorenal syndrome (HRS) and has FDA Fast Track status. For more information, visit http://www.biovieinc.com/Forward-Looking StatementsThis press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company’s ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our clinical trials and to obtain approval for our product candidates, to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company’s control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law.Contact:INVESTOR RELATIONS: Dave Gentry, CEO RedChip Companies Inc. 407-491-4498 dave@redchip.com

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  • BioVie to Present at Oppenheimer Fall Healthcare Life Sciences & Medtech Summit

    SANTA MONICA, CA / ACCESSWIRE / September 21, 2020 / BioVie Inc.

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  • BioVie Inc. Announces Nasdaq Listing and Pricing of $15.7 Million Public Offering

    SANTA MONICA, CA / ACCESSWIRE / September 17, 2020 / BioVie Inc.

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  • Highly Accomplished Executives Join BioVie’s Board of Directors

    Hariri, Gorlin, and Rogich to Contribute Their Tremendous Industry Insights and Stature SANTA MONICA, Calif., June 16, 2020 -- BioVie, Inc. (OTCQB: BIVI) (“BioVie” or.

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  • BioVie Advances the BIV201 Clinical Program and Prefilled Syringe

    Novel BIV201 Formulation Shows Significant Improvements Over Industry TerlipressinPrefilled Syringe May Significantly Extend Market Protection Beyond Orphan Drug Exclusivity.

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