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BioXcel Therapeutics Reports Third Quarter 2021 Financial Results and Recent Operational Highlights
Plans for commercial and launch readiness advancing for BXCL501 orally dissolving film, for the acute treatment of agitation associated with schizophrenia and
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Plans for commercial and launch readiness advancing for BXCL501 orally dissolving film, for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, ahead of January 5, 2022 PDUFA date On track to initiate Phase 3 program for acute treatment of agitation in patients with Alzheimer’s disease in Q4 2021 Strengthened neuroscience franchise with indication expansion for BXCL501 in major depressive disorder (MDD) Introduced BXCL502 candidate for chronic agitation in dementia, identified through Company’s artificial intelligence platform Demonstrated encouraging anti-tumor activity and favorable safety profile for BXCL701 in combination with KEYTRUDA® in mCRPC patients with adenocarcinoma; expansion of Phase 2 trial in SCNC cohort To host conference call today, Nov. 10, 2021, at 8:30 a.m. EDT NEW HAVEN, Conn., Nov. 10, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced its financial results for the third quarter ended September 30, 2021 and provided an update on key strategic initiatives. “We have made tremendous progress advancing our neuroscience and immuno-oncology franchises,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “With our PDUFA date for BXCL501 less than two months away, we are excited that our commercial and launch readiness planning is progressing well. We are equally excited about initiating our Phase 3 program for BXCL501 for acute treatment of agitation associated with dementia in Alzheimer’s patients, the most prevalent type of dementia in the United States, which has a high unmet medical need and we believe would mark the first orally available FDA-approved therapy. Furthermore, adding major depressive disorder as a potential indication for BXCL501 and introducing BXCL502 as a candidate for chronic treatment of agitation in dementia strengthens our pipeline and expands our market opportunity.” Dr. Mehta added, “Our immuno-oncology program is also advancing, with positive interim results from our Phase 2 trial of BXCL701 in heavily pre-treated metastatic castration-resistant prostate cancer (mCRPC) demonstrating encouraging efficacy and a favorable safety profile. We believe BXCL...