BioXcel Therapeutics, a leading biopharmaceutical company based in New Haven, Conn., announced today that its BXCL701 drug candidate has been granted fast-track designation by the U.S. Food and Drug Administration (FDA). This exciting development has caused BioXcel’s shares to soar over 20% in premarket trading.
The FDA’s fast-track program aims to speed up the review and development of treatments for serious or life-threatening conditions with limited treatment options. In this case, the fast-track designation specifically applies to the use of BXCL701 in combination with a checkpoint inhibitor for the treatment of patients with metastatic small cell neuroendocrine prostate cancer. Importantly, these patients must have experienced disease progression while undergoing chemotherapy and show no evidence of microsatellite instability.
Having secured fast-track designation, BioXcel is now focused on discussing the registration path for BXCL701 in an upcoming meeting with the FDA. The company is eager to explore the potential of this innovative therapy and its ability to address the high unmet medical needs of patients with this rare form of prostate cancer.
Following this news, BioXcel shares have experienced a significant upsurge, rising from $2.11 to $2.58 in premarket trading. This reflects investor confidence in the potential success of BXCL701 and its ability to make a meaningful impact on the lives of patients fighting this devastating disease.