BioVie (BIVI) Plunges After Alzheimer’s Drug Fails Phase 3 Due to “Protocol Deviations” at Trial Sites – Hagens Berman

Hagens Berman, National Trial Attorneys, Encourages BIVI Investors with Substantial Losses to Contact Firm

SAN FRANCISCO - 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, 844-916-0895

BioVie Inc. (BIVI) Investigation:

The investigation focuses on the propriety of BioVie’s disclosures concerning its adherence to Good Clinical Practice (“GCP”) and protocols related to its Phase 3 clinical trial of NE3107, a potential Alzheimer’s disease drug.

On Sep. 26, 2023, BioVie announced completion of the last treatment visit in its Phase 3 clinical trial of NE3107. 

But on Nov. 8, 2023, BioVie shocked investors when it 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[.]”

Then, on Nov. 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 an event call, BioVie’s management suggested that the company became aware of Phase 3 deviations beginning as early as July 2023.

In response to these disclosures, the price of BioVie shares fell sharply.

“We’re focused on investors’ losses and are investigating whether BioVie may have intentionally concealed GCP and protocol violations,” said Reed Kathrein, the Hagens Berman partner leading the investigation.

If you invested in BioVie and have substantial losses, or have knowledge that may assist the firm’s investigation, submit your losses now »

If you’d like more information and answers to frequently asked questions about the BioVie investigation, read more »

Whistleblowers: 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 or email BIVI@hbsslaw.com.

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About Hagens Berman
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