BioXcel Investors Advance Suit Over FDA Study Compliance Issues

Sept. 30, 2025, 7:51 PM UTC

BioXcel Therapeutics Inc. shareholders sufficiently alleged the biotechnology company misrepresented a key clinical trial’s enrollment and completeness, a federal judge said while allowing them to file an amended complaint.

Investors leading the case adequately pleaded an inference that executives “intended to deceive and defraud their investors with respect to the enrollment and completion status of the TRANQUILITY II trial, on which the Company’s future so heavily depended,” Judge Sarala V. Nagala said.

Investors Tonya Hills and the Oklahoma Law Enforcement Retirement System could proceed with their third amended complaint limited to those plausibly alleged misstatements, the US District Judge ...

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