NEW YORK, Dec. 18, 2023 /PRNewswire/ — Pomerantz LLP is investigating claims on behalf of BioVie Inc. (“BioVie” or the “Company”) (NASDAQ: BIVI). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.
The investigation concerns whether BioVie and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
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On September 26, 2023, BioVie announced completion of the last treatment visit in its Phase 3 clinical trial of NE3107. On November 8, 2023, BioVie revealed that “during routine monitoring of blinded data from our Phase 3 study of . . . NE3107, we uncovered what appears to be potential scientific misconduct and significant non-compliance with GCPs and regulations at six sites[]” and “[w]e have alerted the FDA’s Office of Scientific Integrity (‘OSI’) about these issues[.]” On this news, BioVie’s stock price fell $1.25 per share, or 29.34%, to close at $3.01 per share on November 9, 2023.
Then, on November 29, 2023, BioVie announced that the Phase 3 trial missed statistical significance “due to site exclusions” and blamed the miss on “significant deviation from protocol and Good Clinical Practice (GCP) violations at 15 sites” leading it to exclude all patients from these sites and referrals of them to the OSI.
On this news, BioVie’s stock price fell $3.03 per share, or 60.72%, to close at $1.96 per share on November 29, 2023.
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CONTACT:
Danielle Peyton
Pomerantz LLP
[email protected]
646-581-9980 ext. 7980
SOURCE Pomerantz LLP
