{"id":44267,"date":"2024-01-05T19:23:05","date_gmt":"2024-01-05T19:23:05","guid":{"rendered":"https:\/\/news.pakistaninewspaperlist.com\/biovie-bivi-plunges-after-alzheimers-drug-fails-phase-3-due-to-protocol-deviations-at-trial-sites-hagens-berman\/"},"modified":"2024-01-05T19:23:05","modified_gmt":"2024-01-05T19:23:05","slug":"biovie-bivi-plunges-after-alzheimers-drug-fails-phase-3-due-to-protocol-deviations-at-trial-sites-hagens-berman","status":"publish","type":"post","link":"https:\/\/pakistaninewspaperlist.com\/news\/biovie-bivi-plunges-after-alzheimers-drug-fails-phase-3-due-to-protocol-deviations-at-trial-sites-hagens-berman\/","title":{"rendered":"BioVie (BIVI) Plunges After Alzheimer\u2019s Drug Fails Phase 3 Due to \u201cProtocol Deviations\u201d at Trial Sites \u2013 Hagens Berman"},"content":{"rendered":"
\n

SAN FRANCISCO, Jan. 05, 2024 (GLOBE NEWSWIRE) — Hagens Berman urges BioVie Inc. (NASDAQ: BIVI)<\/strong> investors who suffered substantial losses to submit your losses now<\/a>.<\/p>\n

Visit:<\/strong> www.hbsslaw.com\/investor-fraud\/BIVI<\/a>
Contact An Attorney Now:<\/strong> BIVI@hbsslaw.com<\/a>
\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0844-916-0895<\/strong><\/p>\n

BioVie Inc. (BIVI) Investigation: <\/strong><\/p>\n

The investigation focuses on the propriety of BioVie\u2019s disclosures concerning its adherence to Good Clinical Practice (\u201cGCP\u201d) and protocols related to its Phase 3 clinical trial of NE3107, a potential Alzheimer\u2019s disease drug.<\/p>\n

On Sep. 26, 2023, BioVie announced completion of the last treatment visit in its Phase 3 clinical trial of NE3107.<\/p>\n

But on Nov. 8, 2023, BioVie shocked investors when it revealed that \u201cduring routine monitoring of blinded data from our Phase 3 study of [\u2026] NE3107, we uncovered what appears to be potential scientific misconduct and significant non-compliance with GCPs and regulations at six sites[]\u201d and \u201c[w]e have alerted the FDA\u2019s Office of Scientific Integrity (\u2018OSI\u2019) about these issues[.]\u201d<\/p>\n

Then, on Nov. 29, 2023, BioVie announced that the Phase 3 trial missed statistical significance \u201cdue to site exclusions\u201d and blamed the miss on \u201csignificant deviation from protocol and Good Clinical Practice (GCP) violations at 15 sites\u201d leading it to exclude all patients from these sites and referrals of them to the OSI.\u00a0\u00a0<\/p>\n

On an event call, BioVie\u2019s management suggested that the company became aware of Phase 3 deviations beginning as early as July 2023.<\/p>\n

In response to these disclosures, the price of BioVie shares fell sharply.<\/p>\n

\u201cWe\u2019re focused on investors\u2019 losses and are investigating whether BioVie may have intentionally concealed GCP and protocol violations,\u201d said Reed Kathrein, the Hagens Berman partner leading the investigation.<\/p>\n

If you invested in BioVie and have substantial losses, or have knowledge that may assist the firm\u2019s investigation, submit your losses now<\/a> \u00bb<\/p>\n

If you\u2019d like more information and answers to frequently asked questions about the BioVie investigation, read more<\/a> \u00bb<\/a><\/p>\n

Whistleblowers: <\/strong>Persons with non-public information regarding BioVie should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895<\/strong> or email BIVI@hbsslaw.com<\/a>.<\/p>\n

About Hagens Berman<\/a>
Hagens Berman is a global plaintiffs\u2019 rights complex litigation law firm focusing on corporate accountability through class-action law. The firm is home to a robust securities litigation practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and fraud. More about the firm and its successes can be found at\u00a0hbsslaw.com<\/a>. Follow the firm for updates and news at\u00a0@ClassActionLaw<\/a>.\u00a0<\/p>\n

Attorney advertising.<\/strong>
Past results do not guarantee future outcomes.<\/strong>
Services may be performed by attorneys in any of our offices<\/strong>.\u00a0<\/p>\n

Contact: <\/u>
Reed Kathrein, 844-916-0895<\/p>\n

\n <\/div>\n","protected":false},"excerpt":{"rendered":"

SAN FRANCISCO, Jan. 05, 2024 (GLOBE NEWSWIRE) — Hagens Berman urges BioVie Inc. (NASDAQ: BIVI) investors who suffered substantial losses to submit your losses now. Visit: www.hbsslaw.com\/investor-fraud\/BIVI Contact An Attorney Now: BIVI@hbsslaw.com \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0844-916-0895 […]<\/p>\n","protected":false},"author":2,"featured_media":44268,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"fifu_image_url":"https:\/\/ml.globenewswire.com\/Resource\/Download\/51670c91-d369-4a8c-8102-d393de9f6d19","fifu_image_alt":"","footnotes":""},"categories":[208],"tags":[],"class_list":["post-44267","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-globenewswire"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/pakistaninewspaperlist.com\/news\/wp-json\/wp\/v2\/posts\/44267","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pakistaninewspaperlist.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pakistaninewspaperlist.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pakistaninewspaperlist.com\/news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/pakistaninewspaperlist.com\/news\/wp-json\/wp\/v2\/comments?post=44267"}],"version-history":[{"count":0,"href":"https:\/\/pakistaninewspaperlist.com\/news\/wp-json\/wp\/v2\/posts\/44267\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pakistaninewspaperlist.com\/news\/wp-json\/wp\/v2\/media\/44268"}],"wp:attachment":[{"href":"https:\/\/pakistaninewspaperlist.com\/news\/wp-json\/wp\/v2\/media?parent=44267"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pakistaninewspaperlist.com\/news\/wp-json\/wp\/v2\/categories?post=44267"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pakistaninewspaperlist.com\/news\/wp-json\/wp\/v2\/tags?post=44267"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}