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BioXcel receives FDA approval for BXCL701 trial

Nov 06, 2018 - Marketline Newswire

BioXcel Therapeutics has received approval from the US Food and Drug Administration (FDA) for an investigational new drug (IND) application for BXCL701.

The approval has enabled BioXcel to conduct a Phase Ib/II trial to evaluate BXCL701, an immuno-oncology product candidate, in combination with pembrolizumab (keytruda) as a potential therapy for treatment-emergent neuroendocrine prostate cancer (tNEPC).Scheduled to begin in the last quarter of this year, the single arm, Simon 2-stage op...