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BTAI

BioXcel Therapeutics

$10.83

0.355 (3.39%)

08:09
05/07/19
05/07
08:09
05/07/19
08:09

BioXcel Therapeutics reports Q1 EPS (46c), consensus (55c)

Dr. Vimal Mehta, CEO of BTI said, "During the first quarter of 2019 a number of positive initiatives continued to drive the ongoing clinical advancement of our lead programs, BXCL501 and BXL701. We anticipate reporting data from our first-in-human pharmacokinetic and safety study of BXCL501 in the coming weeks. The dosing of multiple cohorts has been successfully completed. We believe that these results will help lay the groundwork for launching future registration studies as well as supporting BTI's first New Drug Application (NDA) expected to be filed with the FDA in 2020. Additionally, in order to support the Phase 2/3 registration studies planned to begin in second half of 2019, the process development for BXCL501 sublingual thin film has now been transitioned to an automated robotic aided platform. We intend to employ an automated and scalable manufacturing process for clinical and commercial supply. BXCL501 has demonstrated promising potential with intravenously administered Dex in Phase 1 trials for the acute treatment of agitation in patients with schizophrenia, Alzheimer's disease/ dementia and opioid withdrawal symptoms, where new effective therapies are desperately needed. We continue to believe that BXCL501 has the potential to be applied to a wide number of neuropsychiatric disorders and look forward to exploring opportunities as we advance development in our initial target indications."

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BTAI BioXcel Therapeutics
$10.83

0.355 (3.39%)

12/05/18
HCWC
12/05/18
NO CHANGE
Target $25
HCWC
Buy
BioXcel Therapeutics data establish proof-of-concept, says H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju reiterates a Buy rating on BioXcel Therapeutics with a $25 price target after the company reported that its Phase 1b dose-ranging study of IV form of BXCL501 met the primary endpoint, with 90% of the 10 schizophrenic patients enrolled reaching a Richmond Agitation-Sedation Scale score of -1 without any significant adverse effects being observed. These data provide confirmation that BXCL501 effectively produces arousable sedation in both schizophrenic and bipolar patients, Selvaraju tells investors in a research note. The analyst anticipates that the Phase 1b data in Alzheimer's disease patients, slated for release in the coming weeks, is likely to similarly provide proof-of-concept referential evidence of sedation, albeit perhaps with a different pharmacokinetic profile.

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LSCC

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WVE

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