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BioXcel Therapeutics Receives FDA Fast Track Designation for BXCL501 for Acute Treatment of Agitation

Fast track designation for BXCL501 will help facilitate anticipated registration trials in 2019 upon completion of pharmacokinetic (bioavailability) and safety study

NEW HAVEN, Conn., Dec. 27, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (BTAI), today announced that the U.S. FDA has granted Fast Track Designation for its investigational drug BXCL501, a proprietary sublingual film of dexmedetomidine, for the treatment of acute agitation. BTI is a clinical-stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology.

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https://finance.yahoo.com/news/bioxcel-t...ccounter=1

und nochmal:

BioXcel Therapeutics Reports Positive Human Proof-of-Concept Data for Acute Treatment of Agitation in Patients with Alzheimer’s Disease

Primary endpoint (safety and tolerability) met, with clinical benefit observed in 7 of 10 patients

Proof-of-Concept established in agitated patients across multiple underlying disorders including Alzheimer’s Disease, Schizophrenia, and Delirium  

Trial data, coupled with upcoming results of pharmacokinetic (bioavailability) BXCL501 study to support anticipated registration trial in 2019

Appoints Industry Veteran Dr. Robert Risinger as Vice President, Clinical Development to lead BXCL501 development

Conference call to discuss results and BXCL501 program on January 3, 2019 at 11:30 ET

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https://finance.yahoo.com/news/bioxcel-t...00096.html

passt schon zu den HOT stocks, heute plus 15%, eigentlich sollten die earnings kommen, kam aber nix, 
statt dessen:

HC Wainwright Reiterates $25.00 Price Target for BioXcel Therapeutics (BTAI)

HC Wainwright set a $25.00 target price on BioXcel Therapeutics (NASDAQ:BTAI) in a research report report published on Tuesday. The firm currently has a buy rating on the stock.

Separately, Zacks Investment Research cut BioXcel Therapeutics from a hold rating to a sell rating in a report on Thursday, January 10th. One research analyst has rated the stock with a sell rating and five have issued a buy rating to the company’s stock. The company presently has a consensus rating of Buy and an average target price of $18.67.

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https://www.fairfieldcurrent.com/news/20...-btai.html