BioXcel Therapeutics (BTAI) shares rallied more than 24% premarket after the U.S. Food and Drug Administration (FDA) designated a Fast Track development program for BXCL701.
More specifically, the Fast Track designation is for the investigation of BXCL701 in combination with a CPI for the treatment of patients with metastatic small cell neuroendocrine prostate cancer (SCNC).
The FDA grants Fast Track designation to boost the development of medicines to treat serious conditions, fill unmet medical needs, and bring promising medicines to patients more quickly.
"The FDA's Fast Track designation for the investigation of BXCL701 in SCNC is an important recognition of our most advanced immuno-oncology asset and an acknowledgment of its potential to address the considerable unmet medical need in these patients," said Vimal Mehta, CEO of BioXcel Therapeutics.
He added that the designation further validates the unique AI-based drug re-innovation approach that they used to discover this asset.
As of 07:40 am ET premarket on Monday, BTAI is up 24.2% at $2.60 per share.