Bioxcel Therapeutics: MACD Death Cross and KDJ Death Cross Triggered on 15min Chart

Based on the 15-minute chart for Bioxcel Therapeutics, the MACD Death Cross and KDJ Death Cross signals have been triggered as of 13:45 on 09/02/2023. This indicates a potential continuation of the downward trend in stock price, with a shift in momentum towards the downside and a possible further decrease in value.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) has announced significant progress in its efforts to expand the use of its proprietary sublingual film formulation, BXCL501, for the acute treatment of agitation associated with bipolar disorders or schizophrenia. The company's SERENITY At-Home Pivotal Phase 3 trial, which evaluated the safety of a 120 mcg dose of BXCL501 in the at-home setting, has met its primary endpoint, demonstrating that the drug is well-tolerated and safe for use in the outpatient environment.

The trial, a double-blind, placebo-controlled study, involved 246 patients who experienced 2628 episodes of agitation. Of these, 2437 episodes were treated with BXCL501, with no discontinuations due to tolerability. The data indicate that BXCL501 was consistently well-tolerated across repeat dosing and throughout the trial's duration. No drug-related serious adverse events (SAEs), syncopes, or falls were reported, and the adverse event profile was consistent with previously approved uses of IGALMI®.

The preliminary results from the trial also suggest that BXCL501 continues to show consistent efficacy with repeat dosing, aligning with the positive feedback previously received from the FDA. BioXcel plans to submit a sNDA in the first quarter of 2026 for expanded usage of BXCL501 in the outpatient setting without the supervision of a healthcare provider.

This development is significant as it addresses an unmet medical need in the at-home treatment of agitation, which has previously lacked FDA-approved options. The total addressable market is estimated to be significantly larger than previously reported, with market research indicating that episodes may occur 3-4 times a month on average, with the majority being moderate or severe.

The company's CEO, Vimal Mehta, Ph.D., underscored the importance of this milestone, stating, "The SERENITY At-Home results are transformative in our journey toward outpatient use of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia. By meeting its primary endpoint, the SERENITY At-Home Pivotal Phase 3 trial reinforces BXCL501’s potential to be safely used at home like it is already used in the previously FDA-approved institutional setting."

References:
[1] https://www.biospace.com/press-releases/update-bioxcel-therapeutics-announces-serenity-at-home-pivotal-phase-3-safety-trial-met-its-primary-endpoint-in-support-of-snda-submission-for-label-expansion-of-igalmi