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Wednesday, February 21, 2024

BioXcel Therapeutics surges on FDA fast track designation for BXCL701 By Investing.com

BioXcel Therapeutics surges on FDA fast track designation for BXCL701 By Investing.com


© Reuters. BioXcel Therapeutics (BTAI) Obtains FDA Fast Track Designation for BXCL701

Shares of BioXcel Therapeutics (BTAI) rose more than 24% premarket after the U.S. Food and Drug Administration (FDA) designated an accelerated development program for BXCL701.

More specifically, the Fast Track designation relates to the study 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 spur the development of drugs to treat serious diseases, address unmet medical needs, and bring promising drugs 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 recognition of its potential to address the significant unmet medical needs in these patients,” said Vimal Mehta, CEO of BioXcel. Therapeutic.

He added that this designation further validates the unique AI-driven drug re-innovation approach they used to discover this asset.

As of 7:40 a.m. ET Monday in premarket trading, BTAI was up 24.2% at $2.60 per share.



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