{"success":true,"data":{"pressRelease":{"id":"168825","rtpr_id":"nGNX7cNgh6-20261014","ticker":"BIVI","exchange":"NASDAQ","all_tickers":["BIVI"],"title":"BioVie to Present New Bezisterim Findings in Parkinson’s Disease and Long COVID at the 2026 American Neurological Association Annual Meeting","author":"Globe Newswire","published_at":"2026-10-14T12:00:02.183Z","article_body":"CARSON CITY, Nev., Oct. 14, 2026 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ:\nBIVI) (“BioVie” or the “Company”), a clinical-stage company developing\ninnovative drug therapies for neurological and neurodegenerative diseases,\ntoday announced that two abstracts detailing results from the Company’s\nADDRESS-LC Phase 2 trial in Long COVID, and SUNRISE-PD Phase 2 trial of\nbezisterim in Parkinson’s Disease have been accepted for presentation\nat ANA2026\n(https://www.globenewswire.com/Tracker?data=1S3R_H72jFGJ-Bh3wm0B2MnnOjjIRpfLP1iUlg2KWuZvRSLRD5eijpRCO6wjxyaH2Vddadf1Fedu4MCjE1jRRg==),\nthe annual meeting of the American Neurological Association.\n\nResults of the two studies will be presented as posters during the conference.\nANA2026 will be held in San Diego, CA from October 17-20, 2026.\n\nLong COVID — ADDRESS-LC\nTitle: Results of a Double-Blind, Placebo-Controlled Study of the Efficacy and\nSafety of Bezisterim (NE3107) in Long COVID (ADDRESS-LC)\nAuthors: Penelope Markham (BioVie), Michael J. Peluso (UCSF), Christopher\nReading (BioVie), Clarence Ahlem (BioVie), Stephen O’Quinn (Perissos), Navid\nA. Samad (Samad Consulting), Jeffrey Zhang (Princeton Pharmatech), Joseph M.\nPalumbo (BioVie)\nDate: Sunday, October 18, 2026; Time: 5:30–7:00 PM\n\nParkinson’s disease — SUNRISE-PD\nTitle: Bezisterim (NE3107) in Early Parkinson’s Disease (SUNRISE-PD):\nInitial Results and Observations from a Phase 2 Hybrid Design Trial\nAuthors: Authors: Joseph Palumbo (BioVie); Clarence Ahlem (BioVie);\nChristopher L. Reading (BioVie); Stephen O’Quinn (Perissos); Jeffrey Zhang\n(Princeton Pharmatech); Mark Stacy (Medical University of South Carolina)\nDate: Monday, October 19, 2026; Time: 5:30–7:00 PM\n\nAbout Bezisterim\n\nBezisterim (NE3107) is an investigational oral drug that crosses the\nblood-brain barrier and works to reduce inflammation and improve insulin\nsensitivity without suppressing the immune system and with a low risk of\ndrug-drug interactions. By modulating key pathways involved in\nneuroinflammation (ERK, NFκB, TNFα), bezisterim may have therapeutic\npotential in several disease indications, including Parkinson’s disease\n(PD), Long COVID (LC), and Alzheimer’s disease (AD).\n\nIn PD, BioVie completed the SUNRISE-PD trial, which enrolled 57 patients to\nestablish proof of mechanism and proof of concept in individuals with\nearly-stage disease who had not previously been treated with\ncarbidopa/levodopa. Topline results showed that patients treated with\nbezisterim experienced improvements with blood-based markers of inflammation,\nas well as a broad range of biomarkers associated with cellular health and\nneuronal integrity. Clinically, patients treated with bezisterim demonstrated\ngreater improvements than those receiving placebo across multiple measures of\ndaily functioning, motor symptoms, and non-motor symptoms.\n\nFor LC, the ADDRESS-LC trial enrolled approximately 200 patients to evaluate\nwhether bezisterim may help reduce brain fog, fatigue, and other chronic\nneurological symptoms associated with LC. The hypothesis being studied is that\nthese symptoms may be triggered by persistent circulation of spike protein\nfragments that trigger inflammation via NFκB activation, a pathway that\nbezisterim has been shown to modulate.\n\nIn AD, BioVie has conducted Phase 2 and Phase 3 trials. Preliminary data from\nthese trials suggest improvements in cognition and biomarkers, supporting\nfurther trials to evaluate its potential as a therapy for the six million\nAmericans living with AD.\n\nAbout BioVie Inc.\n\nBioVie Inc. (NASDAQ: BIVI) is a clinical-stage biopharmaceutical company\nfocused on developing therapies for neurological disorders and advanced liver\ndisease. Its lead investigational drug candidate, bezisterim (NE3107), targets\nneuroinflammation and insulin resistance, which are believed to be key drivers\nof Alzheimer’s and Parkinson’s disease. Bezisterim is also being studied\nfor Long COVID, where persistent inflammation is thought to underlie symptoms\nsuch as brain fog and fatigue.\n\nIn liver disease, BioVie is advancing BIV201, a continuous infusion of\nterlipressin treatment that has received FDA Orphan and Fast Track\ndesignations. The active agent is approved in the U.S. and in about 40\ncountries for related complications of advanced liver cirrhosis, and the\nCompany plans to study BIV201 in a Phase 3 trial for the reduction of further\ndecompensation in patients with cirrhosis and ascites. For more information,\nvisit www.bioviepharma.com.\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements, which may be\nidentified by words such as \"expect,\" \"look forward to,\" \"anticipate,\"\n\"intend,\" \"plan,\" \"believe,\" \"seek,\" \"estimate,\" \"will,\" \"project,\"\n“potential,” “may,” or words of similar meaning. Forward-looking\nstatements in this release include, but are not limited to, statements\nregarding: the potential for bezisterim to address unmet clinical needs in\nLong COVID and Parkinson’s disease; the design and conduct of future\nclinical trials, including a potentially pivotal Phase 3 trial; the potential\nclinical significance of subgroup analyses and biomarker observations; and the\nCompany’s ability to advance bezisterim through clinical development. The\nclinical endpoints reported in this release are exploratory in nature. The\nPhase 2 ADDRESS-LC trial did not achieve statistical significance on any\nendpoint in the overall intent-to-treat population; statistically significant\nresults were observed only in pre-specified subgroup analyses. Subgroup\nanalyses are hypothesis-generating and may not be replicated in future trials.\nChanges in biomarkers may not correlate with clinical benefit or support\nregulatory approval. The FDA has not validated these endpoints as surrogate\nendpoints for Long COVID. Although BioVie Inc. believes such forward-looking\nstatements are based on reasonable assumptions, it can give no assurance that\nits expectations will be attained. Actual results may vary materially from\nthose expressed or implied by the statements herein due to risks related to\nthe early stage of development of bezisterim and other product candidates, the\npossibility that results observed in this Phase 2 study of 203 patients may\nnot be replicated in larger or longer-duration trials, the exploratory nature\nof subgroup analyses, the Company's ability to successfully raise sufficient\ncapital on reasonable terms or at all, available cash on hand and contractual\nand statutory limitations that could impair our ability to pay future\ndividends, our ability to complete our pre-clinical or clinical studies and to\nobtain approval for our product candidates, the possibility that clinical\ntrial results may not be indicative of results in subsequent or larger trials,\nour ability to successfully defend potential future litigation, changes in\nlocal or national economic conditions as well as various additional risks,\nmany of which are now unknown and generally out of the Company's control, and\nwhich are detailed from time to time in reports filed by the Company with the\nSEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual\nreports on Form 10-K. BioVie Inc. does not undertake any duty to update any\nstatements contained herein (including any forward-looking statements), except\nas required by law.\n\nFor Investor Relations Inquiries:\n         \nContact:\nChuck Padala\nManaging Director, LifeSci Advisors, LLC\nchuck@lifesciadvisors.com\n\nFor Media Inquiries:\n         \nContact:\nMelyssa Weible\nManaging Partner, Elixir Health Public Relations \nmweible@elixirhealthpr.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/f437d04b-c089-46eb-bca8-7ef64f68bc9b)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX7cNgh6-20261014","title":"BioVie to Present New Bezisterim Findings in Parkinson’s Disease and Long COVID at the 2026 American Neurological Association Annual Meeting","author":"Globe Newswire","ticker":"BIVI","created":"2026-10-14T12:00:02.183Z","tickers":["BIVI"],"exchange":"NASDAQ","article_body":"CARSON CITY, Nev., Oct. 14, 2026 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ:\nBIVI) (“BioVie” or the “Company”), a clinical-stage company developing\ninnovative drug therapies for neurological and neurodegenerative diseases,\ntoday announced that two abstracts detailing results from the Company’s\nADDRESS-LC Phase 2 trial in Long COVID, and SUNRISE-PD Phase 2 trial of\nbezisterim in Parkinson’s Disease have been accepted for presentation\nat ANA2026\n(https://www.globenewswire.com/Tracker?data=1S3R_H72jFGJ-Bh3wm0B2MnnOjjIRpfLP1iUlg2KWuZvRSLRD5eijpRCO6wjxyaH2Vddadf1Fedu4MCjE1jRRg==),\nthe annual meeting of the American Neurological Association.\n\nResults of the two studies will be presented as posters during the conference.\nANA2026 will be held in San Diego, CA from October 17-20, 2026.\n\nLong COVID — ADDRESS-LC\nTitle: Results of a Double-Blind, Placebo-Controlled Study of the Efficacy and\nSafety of Bezisterim (NE3107) in Long COVID (ADDRESS-LC)\nAuthors: Penelope Markham (BioVie), Michael J. Peluso (UCSF), Christopher\nReading (BioVie), Clarence Ahlem (BioVie), Stephen O’Quinn (Perissos), Navid\nA. Samad (Samad Consulting), Jeffrey Zhang (Princeton Pharmatech), Joseph M.\nPalumbo (BioVie)\nDate: Sunday, October 18, 2026; Time: 5:30–7:00 PM\n\nParkinson’s disease — SUNRISE-PD\nTitle: Bezisterim (NE3107) in Early Parkinson’s Disease (SUNRISE-PD):\nInitial Results and Observations from a Phase 2 Hybrid Design Trial\nAuthors: Authors: Joseph Palumbo (BioVie); Clarence Ahlem (BioVie);\nChristopher L. Reading (BioVie); Stephen O’Quinn (Perissos); Jeffrey Zhang\n(Princeton Pharmatech); Mark Stacy (Medical University of South Carolina)\nDate: Monday, October 19, 2026; Time: 5:30–7:00 PM\n\nAbout Bezisterim\n\nBezisterim (NE3107) is an investigational oral drug that crosses the\nblood-brain barrier and works to reduce inflammation and improve insulin\nsensitivity without suppressing the immune system and with a low risk of\ndrug-drug interactions. By modulating key pathways involved in\nneuroinflammation (ERK, NFκB, TNFα), bezisterim may have therapeutic\npotential in several disease indications, including Parkinson’s disease\n(PD), Long COVID (LC), and Alzheimer’s disease (AD).\n\nIn PD, BioVie completed the SUNRISE-PD trial, which enrolled 57 patients to\nestablish proof of mechanism and proof of concept in individuals with\nearly-stage disease who had not previously been treated with\ncarbidopa/levodopa. Topline results showed that patients treated with\nbezisterim experienced improvements with blood-based markers of inflammation,\nas well as a broad range of biomarkers associated with cellular health and\nneuronal integrity. Clinically, patients treated with bezisterim demonstrated\ngreater improvements than those receiving placebo across multiple measures of\ndaily functioning, motor symptoms, and non-motor symptoms.\n\nFor LC, the ADDRESS-LC trial enrolled approximately 200 patients to evaluate\nwhether bezisterim may help reduce brain fog, fatigue, and other chronic\nneurological symptoms associated with LC. The hypothesis being studied is that\nthese symptoms may be triggered by persistent circulation of spike protein\nfragments that trigger inflammation via NFκB activation, a pathway that\nbezisterim has been shown to modulate.\n\nIn AD, BioVie has conducted Phase 2 and Phase 3 trials. Preliminary data from\nthese trials suggest improvements in cognition and biomarkers, supporting\nfurther trials to evaluate its potential as a therapy for the six million\nAmericans living with AD.\n\nAbout BioVie Inc.\n\nBioVie Inc. (NASDAQ: BIVI) is a clinical-stage biopharmaceutical company\nfocused on developing therapies for neurological disorders and advanced liver\ndisease. Its lead investigational drug candidate, bezisterim (NE3107), targets\nneuroinflammation and insulin resistance, which are believed to be key drivers\nof Alzheimer’s and Parkinson’s disease. Bezisterim is also being studied\nfor Long COVID, where persistent inflammation is thought to underlie symptoms\nsuch as brain fog and fatigue.\n\nIn liver disease, BioVie is advancing BIV201, a continuous infusion of\nterlipressin treatment that has received FDA Orphan and Fast Track\ndesignations. The active agent is approved in the U.S. and in about 40\ncountries for related complications of advanced liver cirrhosis, and the\nCompany plans to study BIV201 in a Phase 3 trial for the reduction of further\ndecompensation in patients with cirrhosis and ascites. For more information,\nvisit www.bioviepharma.com.\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements, which may be\nidentified by words such as \"expect,\" \"look forward to,\" \"anticipate,\"\n\"intend,\" \"plan,\" \"believe,\" \"seek,\" \"estimate,\" \"will,\" \"project,\"\n“potential,” “may,” or words of similar meaning. Forward-looking\nstatements in this release include, but are not limited to, statements\nregarding: the potential for bezisterim to address unmet clinical needs in\nLong COVID and Parkinson’s disease; the design and conduct of future\nclinical trials, including a potentially pivotal Phase 3 trial; the potential\nclinical significance of subgroup analyses and biomarker observations; and the\nCompany’s ability to advance bezisterim through clinical development. The\nclinical endpoints reported in this release are exploratory in nature. The\nPhase 2 ADDRESS-LC trial did not achieve statistical significance on any\nendpoint in the overall intent-to-treat population; statistically significant\nresults were observed only in pre-specified subgroup analyses. Subgroup\nanalyses are hypothesis-generating and may not be replicated in future trials.\nChanges in biomarkers may not correlate with clinical benefit or support\nregulatory approval. The FDA has not validated these endpoints as surrogate\nendpoints for Long COVID. Although BioVie Inc. believes such forward-looking\nstatements are based on reasonable assumptions, it can give no assurance that\nits expectations will be attained. Actual results may vary materially from\nthose expressed or implied by the statements herein due to risks related to\nthe early stage of development of bezisterim and other product candidates, the\npossibility that results observed in this Phase 2 study of 203 patients may\nnot be replicated in larger or longer-duration trials, the exploratory nature\nof subgroup analyses, the Company's ability to successfully raise sufficient\ncapital on reasonable terms or at all, available cash on hand and contractual\nand statutory limitations that could impair our ability to pay future\ndividends, our ability to complete our pre-clinical or clinical studies and to\nobtain approval for our product candidates, the possibility that clinical\ntrial results may not be indicative of results in subsequent or larger trials,\nour ability to successfully defend potential future litigation, changes in\nlocal or national economic conditions as well as various additional risks,\nmany of which are now unknown and generally out of the Company's control, and\nwhich are detailed from time to time in reports filed by the Company with the\nSEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual\nreports on Form 10-K. BioVie Inc. does not undertake any duty to update any\nstatements contained herein (including any forward-looking statements), except\nas required by law.\n\nFor Investor Relations Inquiries:\n         \nContact:\nChuck Padala\nManaging Director, LifeSci Advisors, LLC\nchuck@lifesciadvisors.com\n\nFor Media Inquiries:\n         \nContact:\nMelyssa Weible\nManaging Partner, Elixir Health Public Relations \nmweible@elixirhealthpr.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/f437d04b-c089-46eb-bca8-7ef64f68bc9b)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-14T12:00:02.954470503Z","server_sent_at_ms":1791979202954},"received_at":"2026-10-14T12:00:03.007Z","source_url":null},"analysis":{"id":"157083","press_release_id":"168825","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["ADDRESS-LC did not achieve statistical significance on any endpoint in the overall intent-to-treat population; positive findings are exploratory subgroup analyses","going-concern-adjacent language on ability to raise sufficient capital on reasonable terms"],"eventType":"clinical_trial","narrative":"BioVie will present poster abstracts from its ADDRESS-LC Phase 2 trial in Long COVID and SUNRISE-PD Phase 2 trial of bezisterim in Parkinson's disease at the American Neurological Association's ANA2026 meeting in San Diego, October 17-20, 2026.\n\nSUNRISE-PD enrolled 57 treatment-naive early Parkinson's patients and showed improvements in inflammatory biomarkers and multiple clinical measures versus placebo; ADDRESS-LC enrolled roughly 200 patients but did not achieve statistical significance in the intent-to-treat population.\n\nThis is a conference-visibility event rather than new data; the company itself cautions that subgroup analyses are exploratory and hypothesis-generating.","sentiment":"neutral","agentHooks":{"shouldPost":false,"suggestedAngle":"Routine conference poster acceptance for BioVie's Phase 2 programs -- monitor actual poster content, not the announcement."},"keyFigures":{"drugName":"bezisterim (NE3107)","phaseOfTrial":"Phase 2","customDimensions":{"address_lc_enrollment":"approximately 200 (203 referenced in forward-looking statements)","sunrise_pd_enrollment":57}},"namedEntities":{"people":[{"name":"Joseph M. Palumbo","role":"BioVie author"},{"name":"Michael J. Peluso","role":"UCSF, ADDRESS-LC co-author"},{"name":"Mark Stacy","role":"Medical University of South Carolina, SUNRISE-PD co-author"},{"name":"Chuck Padala","role":"Managing Director, LifeSci Advisors (IR contact)"}],"products":["bezisterim (NE3107)","BIV201 (terlipressin)"],"companies":[{"name":"BioVie Inc.","ticker":"BIVI","relationship":"filer"},{"name":"American Neurological Association","relationship":"conference host"},{"name":"LifeSci Advisors","relationship":"investor relations"},{"name":"Elixir Health Public Relations","relationship":"media relations"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Acceptance of two poster abstracts at a scientific conference is a routine, non-binary disclosure. The release contains no new efficacy data beyond previously disclosed Phase 2 results, and forward-looking language notes ADDRESS-LC missed statistical significance in the intent-to-treat population."},"tickerRelevance":{"others":[],"primary":"BIVI"},"globalImportance":15,"audienceRelevance":12,"eventTypeSecondary":["operations_update"],"importanceComponents":{"tickerTier":"micro-cap","eventGravity":"conference-abstract-acceptance","newDataDisclosed":false}},"event_type":"clinical_trial","event_type_secondary":["operations_update"],"sentiment":"neutral","material_impact_score":2,"narrative":"BioVie will present poster abstracts from its ADDRESS-LC Phase 2 trial in Long COVID and SUNRISE-PD Phase 2 trial of bezisterim in Parkinson's disease at the American Neurological Association's ANA2026 meeting in San Diego, October 17-20, 2026.\n\nSUNRISE-PD enrolled 57 treatment-naive early Parkinson's patients and showed improvements in inflammatory biomarkers and multiple clinical measures versus placebo; ADDRESS-LC enrolled roughly 200 patients but did not achieve statistical significance in the intent-to-treat population.\n\nThis is a conference-visibility event rather than new data; the company itself cautions that subgroup analyses are exploratory and hypothesis-generating.","key_figures":{"drugName":"bezisterim (NE3107)","phaseOfTrial":"Phase 2","customDimensions":{"address_lc_enrollment":"approximately 200 (203 referenced in forward-looking statements)","sunrise_pd_enrollment":57}},"named_entities":{"people":[{"name":"Joseph M. Palumbo","role":"BioVie author"},{"name":"Michael J. Peluso","role":"UCSF, ADDRESS-LC co-author"},{"name":"Mark Stacy","role":"Medical University of South Carolina, SUNRISE-PD co-author"},{"name":"Chuck Padala","role":"Managing Director, LifeSci Advisors (IR contact)"}],"products":["bezisterim (NE3107)","BIV201 (terlipressin)"],"companies":[{"name":"BioVie Inc.","ticker":"BIVI","relationship":"filer"},{"name":"American Neurological Association","relationship":"conference host"},{"name":"LifeSci Advisors","relationship":"investor relations"},{"name":"Elixir Health Public Relations","relationship":"media relations"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-14T12:00:25.539Z","global_importance":15,"audience_relevance":12,"importance_components":{"tickerTier":"micro-cap","eventGravity":"conference-abstract-acceptance","newDataDisclosed":false}},"durationMs":5969,"modelName":"glm-5.3-flashx"}}