UPDATE: BioXcel Therapeutics Inc. (BTAI) is making headlines as its stock skyrocketed 19.09% in after-hours trading, reaching $6.24 per share just hours before crucial clinical trial results are set to be released. This surge comes as investors eagerly await a pivotal conference call scheduled for today at 8 a.m. ET.
The investor call will provide topline results from the SERENITY At-Home Pivotal Phase 3 safety trial, which evaluates BXCL501, a proprietary sublingual film formulation of dexmedetomidine. This treatment aims to address agitation associated with bipolar disorders or schizophrenia in at-home settings, a significant advancement for patients who require immediate care.
Earlier in the day, BTAI closed regular trading at $5.24, reflecting a 1.55% increase prior to the after-hours spike. Over the past year, the stock has seen notable volatility, fluctuating between $1.17 and $13.36, with a current market capitalization of $73.62 million and an average volume of 17.17 million shares.
The SERENITY trial includes 200 patients diagnosed with bipolar disorder or schizophrenia, assessing the safety of BXCL501 versus a placebo over a 12-week period during agitation episodes. This trial represents a critical step for BioXcel, as their existing product, IGALMI® (dexmedetomidine) sublingual film, is already approved for treating agitation under medical supervision. The potential to expand its use to at-home settings could open up a substantial market opportunity.
Moreover, BXCL501 has garnered attention from the FDA, receiving both Breakthrough Therapy designation for treating acute agitation in dementia and Fast Track designation for applications in schizophrenia and bipolar disorders. If the trial results are favorable, these designations could expedite the approval process, benefiting patients in urgent need of effective treatment.
Benzinga’s Edge Stock Rankings show a strong momentum for BTAI, placing it in the 87th percentile with a positive price trend across all time frames. Investors are keenly watching these developments, recognizing the potential impact of BXCL501 on the precision medicine landscape.
As the clock ticks down to the 8 a.m. conference call, all eyes are on BioXcel Therapeutics. The results could shape the future of treatment options for patients battling severe agitation related to mental health disorders. Stay tuned for live updates as this story unfolds.
“This could revolutionize at-home care for patients experiencing agitation,” said an industry analyst, highlighting the human impact of these trial results.
For ongoing coverage and updates, keep following our live news feed as we bring you the latest on BioXcel’s promising developments.
