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BTAI.US
id: 772

BioXcel Therapeutics (BTAI) Investigator Misconduct Case

D. Connecticut
Court
23-cv-00915
Case number
15 Dec 2021
Class period Start
28 Jun 2023
Class period End
05 Sept 2023
Lead Plaintiff motion deadline
  • BioXcel disclosed that its principal investigator for the Phase 3 TRANQUILITY II clinical trial had failed to adhere to the informed consent form and may have fabricated email correspondence.
  • $BTAI fell 63%+ and lost over $320M of its market cap.
  • Investors suspect BioXcel & its Accountables of misleading.
On June 29, 2023, BioXcel Therapeutics, Inc. (BTAI) disclosed that its principal investigator for the Phase 3 TRANQUILITY II clinical trial had failed to “adhere to the informed consent form approved by the Institutional Review Board” for some subjects and failed to maintain adequate case histories for certain patients whose records were reviewed by the FDA.
BioXcel further disclosed that:
  • the same principal investigator “may have fabricated” email correspondence purporting to demonstrate that the investigator timely submitted to the Company’s pharmacovigilance safety vendor a report of a serious adverse event, purporting to show that the vendor had confirmed receipt.
  • the fabricated email correspondence was provided to the FDA during an on-site inspection in December 2022.
  • the Company was investigating protocol adherence and data integrity at the principal investigator’s trial site and was retaining an independent third party to audit the data collected at the site.
  • the foregoing “may impact the timing of the Company’s development plans for, and prospects for regulatory approval of, BXCL501 for the acute treatment of agitation associated with dementia in patients with probable Alzheimer’s disease.”
On this news, $BTAI fell 63.8% and lost over $320 million of its market capitalization, seriously damaging investors.

Considering all the facts, Investors have reasons to suspect BioXcel & its Accountables of misleading and failing to disclose to investors that:
  1. the Company lacked adequate internal controls over protocol adherence and data integrity;
  2. the Company’s principal investigator failed to adhere to the informed consent form approved by the Institutional Review Board;
  3. the Company’s principal investigator failed to maintain adequate case histories for certain patients whose records were reviewed by the FDA;
  4. the Company’s principal investigator fabricated email correspondence with a pharmacovigilance safety vendor that was then provided to the FDA;
  5. the foregoing would negatively impact the Company’s ability to obtain regulatory approval of BXCL501 for the treatment of agitation associated with dementia in patients with probable Alzheimer’s disease; and
  6. as a result of the foregoing, the positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
Case Status
Motion to dismiss
Alleged Offence
Misleading Statements, 
Failure to Disclose, 
Negligence, 
Omissions
Suspected Party
Directors, 
Management, 
Service Provider
Security Type
Stocks
Trade Direction
Long
Shock Event Date
29 June 2023
Filing date
05 July 2023
Lead Plaintiff Deadline
05 September 2023
Judge
Hon. Sarala Vidya Nagala
Collecting participants…