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NEW HAVEN: BioXcel Therapeutics, Inc. announced its clinical prioritization and an update on its late-stage development programs for the treatment of agitation with BXCL501. The clinical prioritization is intended to [...]

E stimated 23 million annual agitation episodes in the at-home setting [sup. 1-3 ] No FDA-approved therapies in the at-home setting for acute treatment of agitation associated with bipolar disorders [...]

Planning initiation of SERENITY At-Home pivotal Phase 3 trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia Advancing plans for TRANQUILITY In-Care pivotal Phase 3 [...]

Focused market-access strategy generates estimated net revenue of approximately $1.1 million, highest quarterly net revenue since commercial launch Represents 90% increase from the prior quarter and 141% increase from the [...]

Study achieved its objective and demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with 180 mcg dose (highest approved dose) For each episode occurring over seven days, a reduction in [...]

NEW HAVEN, Conn., May 28, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced [...]

ENPNewswire-May 22, 2024--BioXcel Therapeutics Announces Oral and Poster Presentations at the 2024 American Society of Clinical Psychopharmacology Annual Meeting (C)2024 ENPublishing - http://www.enpublishing.co.uk Release date- 21052024 - NEW HAVEN - [...]

NEW HAVEN, Conn., May 21, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced [...]

Company plans to initiate trial following recent meeting with FDA No FDA-approved therapies for acute treatment of AAD are currently available NEW HAVEN, Conn., April 10, 2024 (GLOBE NEWSWIRE) -- [...]

Provides update on two late-stage clinical programs for BXCL501 for potential treatment of agitation Recently completed meetings with U.S. Food and Drug Administration for TRANQUILITY and SERENITY programs C onference [...]

Vincent J. O'Neill, M.D., promoted to Executive Vice President, Chief of Product Development and Medical Officer Rajiv Patni, M.D., appointed Strategic Clinical Advisor to CEO and Board of Directors NEW [...]

Company plans to conduct Phase 3 trial of BXCL501 in the at-home setting for TRANQUILITY program to support potential sNDA for acute treatment of agitation associated with dementia due to [...]

Standardizes and improves product reimbursement process New HCPCS Level II code J1105 to be effective January 1, 2024 NEW HAVEN, Conn., Oct. 30, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. [...]

NEW HAVEN, Conn: BioXcel Therapeutics has issued the following news release: BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced [...]

B usiness to prioritize high- potential agitation market opportunities for BXCL501 in bipolar disorders, schizophrenia, and Alzheimer's disease Commercial reprioritization intended to reduce related expenses by 80% with focus on [...]

Following the news that BioXcel Therapeutics announced positive top-line results from TRANQUILITY II (NCT05271552), a Phase III study of Igalmi (dexmedetomidine sublingual film) for the acute treatment of agitation episodes associated with Alzheimer's disease (AD), a senior neurology analyst at GlobalData, offers her view. Although the clinical trial met its primary endpoint for the high dose of the drug, the positive results have been overshadowed by several counts of bad clinical practice disclosed by the company, and therefore there are concerns surrounding the validity of some of the data from the trial. If an additional clinical trial was to be required by the FDA, it will put BioXcel on the back-foot in the market for treating agitation associated with AD, delaying Igalmi's launch behind many potential competitors. There are several other products currently in Phase III development for AD-related agitation, including Avanir Pharmaceuticals' deuterated form of dextromethorphan/quinidine AVP-786, Axsome Therapeutics' NMDA-R antagonist Auvelity (bupropion + dextromethorphan), and Suven Life Sciences' 5-hydroxytryptamine receptor 6 antagonist masupirdine. Additionally, Otsuka's Rexulti (brexpiprazole) became the first drug to be approved by the FDA for agitation associated with AD, on 10 May 2023. Furthermore, even if the clinical trial data is deemed sufficient to allow a supplemental drug application and subsequent approval, there could still be negative opinion surrounding BioXcel and Igalmi, resulting in preferential use of other products by physicians and patients, damaging potential sales for the drug. BioXcel is making good strides in addressing the issue but will need to provide ample data to the AD community to ensure future trust. Original source: Global Data, website: http://www.energy.globaldata.com, Copyright Global Data 2023., market; research and development; sales; antisenility drugs; Auvelity; brexpiprazole; bupropion; dexmedetomidine; dextromethorphan; Igalmi; masupirdine; quinidine; Rexulti; Avanir Pharmaceuticals; Axsome Therapeutics; BioXcel Therapeutics; Otsuka; Suven Life [...]

Clinically meaningful efficacy results observed with half (60mcg) of the approved dose of IGALMI(TM) Greater than 50% PEC response rate attained; proportionally consistent with dose response when compared to rates [...]

BXCL501 was well tolerated across a broad dose range from 30mcg to 140mcg administered chronically Planning Phase 2 human proof-of-concept study to evaluate BXCL501 as a potential adjunctive treatment in [...]

NEW HAVEN: BioXcel Therapeutics has issued the following news release: BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, [...]

NEW HAVEN: BioXcel Therapeutics has issued the following news release: BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, [...]

NEW HAVEN: BioXcel Therapeutics has issued the following news release: BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, [...]

NEW HAVEN, Conn: BioXcel Therapeutics has issued the following news release: BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and [...]

IGALMI(TM) (dexmedetomidine) commercial execution fully underway in 2023 with key focus on market access and demand generation through expanded field team Multiple pivotal data readouts for BXCL501 expected in Q2 [...]

(GlobeNewswire) - BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vimal Mehta, Ph.D., CEO of [...]

NEW HAVEN, Conn., Feb. 21, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today [...]

IGALMI(TM) (dexmedetomidine) well-positioned for growth in 2023 based on increasing market access, efficient targeting, favorable market drivers, and sales force expansion in all major U.S. geographies Top-line pivotal data for [...]

NEW HAVEN, Conn., Oct. 05, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today [...]

NEW HAVEN, Conn., Aug 09, 2022 (GLOBE NEWSWIRE via COMTEX) -- Commercially launched IGALMI(TM) (dexmedetomidine) sublingual film for the acute treatment of agitation in bipolar I or II disorder and [...]

NEW HAVEN, Jul 05, 2022 (GLOBE NEWSWIRE via COMTEX) -- EQNX::TICKER_START (NASDAQ:BTAI), EQNX::TICKER_END BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines [...]

NEW HAVEN, Jun 07, 2022 (GLOBE NEWSWIRE via COMTEX) -- EQNX::TICKER_START (NASDAQ:BTAI), EQNX::TICKER_END BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines [...]

NEW HAVEN, May 09, 2022 (GLOBE NEWSWIRE via COMTEX) -- EQNX::TICKER_START (NASDAQ:BTAI), EQNX::TICKER_END Received FDA approval of IGALMI(TM) (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or [...]

NEW HAVEN, May 05, 2022 (GLOBE NEWSWIRE via COMTEX) -- EQNX::TICKER_START (NASDAQ:BTAI), EQNX::TICKER_END BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines [...]