BioXcel Therapeutics reported its financial results for the third quarter of 2024, alongside updates on its clinical development programs. For the nine months ended September 30, 2024, net revenue from IGALMI was $1.9 million, marking an 89% increase from the prior year period. The company continues to incur substantial losses and negative operating cash flow.
The company announced significant progress in its pivotal Phase 3 trials for BXCL501. The first patient was randomized in the SERENITY At-Home trial, which is evaluating BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia. This trial targets an estimated 23 million annual agitation episodes in the U.S. at-home setting.
BioXcel also received FDA feedback on the protocol for its TRANQUILITY In-Care trial, which aims to treat agitation associated with Alzheimer’s dementia (AAD). These advancements are critical for expanding the potential market for BXCL501, addressing large, untapped needs where no approved acute therapies currently exist.
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