Business
BioXcel Therapeutics Reports Second Quarter 2021 Financial Results and Recent Operational Highlights
Phase 3 study of BXCL501 for the acute treatment of agitation associated with dementia expected to begin in Q4 2021 PDUFA date of January 5, 2022 assigned to
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Phase 3 study of BXCL501 for the acute treatment of agitation associated with dementia expected to begin in Q4 2021 PDUFA date of January 5, 2022 assigned to BXCL501 NDA for the acute treatment of agitation associated with schizophrenia and bipolar disorders I & II Data from adenocarcinoma cohort of Phase 1b/2 study of BXCL701 and KEYTRUDA® in aggressive forms of prostate cancer anticipated in Q3 2021 Raised gross proceeds of approximately $100 million with a common stock offering in June to further fund ongoing clinical development studies and commercialization readiness preparations Company to host a conference call today, August 10, 2021 at 8:30 a.m. EDT NEW HAVEN, Conn., Aug. 10, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (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 second quarter ended June 30, 2021 and provided an update on key strategic initiatives. “During the second quarter, we continued to successfully execute across our clinical, regulatory and commercial objectives for our neuroscience candidate, BXCL501, including furthering our plans for the pivotal Phase 3 program in dementia, executing on our global expansion strategy, and advancing through the regulatory review process,” said Vimal Mehta, Ph.D., CEO of BioXcel. “With acceptance of our NDA by the FDA, we are one step closer to our first-ever product approval and making this innovative therapy available to patients suffering from acute agitation associated with schizophrenia and bipolar disorders. We continue to advance our commercial readiness strategy, if approved, and in parallel are advancing our strategic plans for geographic expansion.” Dr. Mehta added, “Looking ahead, we remain confident in the broad potential of BXCL501 across multiple indications where there is significant need for innovative treatments. We remain on track to commence our Phase 3 program for the acute treatment of agitation associated with dementia in the fourth quarter of this year and are exploring additional pipeline opportunities as growth drivers for this business. Looking beyond our neuroscience program, our Phase 1/2b study of BXCL701 for castrate resistant prostate can...