BioXcel Therapeutics, Inc. (NASDAQ: BTAI) observed a substantial increase in its stock value, rising by 26.02% in the prior trading session to reach $3.10. This surge stemmed primarily from the cancellation of a proposed equity action and a significant regulatory progression.
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BioXcel (BTAI) decided to withdraw the $60.0 million in common shares or pre-funded warrants that were first announced on February 8, 2024. A detailed analysis of the state of the market had an impact on this choice, and the company’s management came to the conclusion that carrying out the offering would not be advantageous to its investors. Consequently, no securities were sold as part of this offer.
BioXcel’s attention now turns to an upcoming pivotal meeting with the U.S. Food and Drug Administration (FDA) set for February 20, 2024, regarding its Phase 3 TRANQUILITY At Clinical trial. This trial seeks to evaluate the effectiveness of BXCL501 as a potential immediate treatment for agitation linked with dementia caused by likely Alzheimer’s disease in a home environment. Expected data release from this trial is scheduled for the first quarter of 2025.
Furthermore, the FDA has given Fast Track designation to the exploration of BXCL701 in conjunction with a CPI for managing patients with metastatic small cell neuroendocrine prostate cancer (SCNC) who have advanced on chemotherapy and exhibit no signs of microsatellite instability.
This designation expedites development and review processes for medications targeting severe conditions with unmet medical requirements, possibly resulting in accelerated approval and priority review. The Fast Track designation underscores the significance of BioXcel’s advanced immuno-oncology asset, BXCL701, and acknowledges its potential to address the substantial medical gaps in SCNC patients.
This recognition further validates the company’s distinctive AI-driven drug re-innovation approach, which was instrumental in discovering BXCL701. With promising results from clinical trials thus far, BioXcel plans to delineate the asset’s development trajectory while exploring strategic opportunities for its subsidiary, OnkosXcel Therapeutics.
