BioXcel Therapeutics Shares Rise Premarket on FDA Fast-Track Designation

By Colin Kellaher

Shares of BioXcel Therapeutics jumped more than 20% in premarket trading Monday after the biopharmaceutical company said the U.S. Food and Drug Administration granted fast-track designation to its BXCL701 drug candidate in patients with a rare form of prostate cancer.

The New Haven, Conn., company said the designation covers BXCL701 in combination with a checkpoint inhibitor for the treatment of patients with metastatic small cell neuroendocrine prostate cancer with progression on chemotherapy and no evidence of microsatellite instability.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

BioXcel said it plans to discuss the registration path for BXCL701 at an upcoming meeting with the FDA.

BioXcel shares, which closed Friday at $2.11, were recently up 22% to $2.58 in premarket trading.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

February 12, 2024 07:42 ET (12:42 GMT)

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