BioXcel Therapeutics

BioXcel Therapeutics, Inc. is a commercial-stage biopharmaceutical company, which engages in utilizing artificial intelligence approaches to develop medicines in neuroscience and immuno-oncology. The firm offers IGALMI, a proprietary, sublingual film formulation of dexmedetomidine for the acute treatment of agitation associated with schizophrenia or bipolar disorder in adults. It also develops BXCL701, an investigational, orally administered, systemic innate immunity activator for the treatment of prostate cancer and solid tumors that are refractory to checkpoint inhibitors. The company was founded by Vimal D. Mehta on March 29, 2017 and is headquartered in New Haven, CT.

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BioXcel Therapeutics reports FDA approval milestone and financial resilience

BioXcel Therapeutics showcased strong financials with a net revenue of $238,000 and a net loss of $54.8 million, underpinned by a solid cash position of $193.7 million.
The FDA approval of IGALMI and upcoming clinical data announcements demonstrate progress in drug development and commercialization efforts.
While facing challenges such as slow product uptake and operating cost uncertainties, BioXcel has opportunities to drive market penetration through strategic initiatives.
The company's strengths lie in its innovative AI platform, strong cash reserves, and proactive approach to advancing its pipeline and commercialization strategies.

BioXcel Therapeutics reports Q1 progress, eyes revenue growth opportunities

BioXcel Therapeutics showcased strong commercial and clinical progress in Q1 2023 earnings call.
While facing challenges in dose selection and strategic options, the company remains optimistic about revenue growth.
Opportunities lie in maintaining commercial metrics, advancing clinical pipeline, and leveraging FDA-approved products.

BioXcel Therapeutics reports Q2 results, refocuses strategy for growth

BioXcel Therapeutics navigated challenges from investigator misconduct by refocusing on key therapeutic areas and strategic partnerships for financial stability.
Despite workforce reductions and operational changes, the company remains committed to advancing treatments for neurological disorders and sharing progress transparently.
Ongoing FDA discussions, positive trial results, and strategic reprioritization position BioXcel Therapeutics for potential growth and regulatory milestones.

BioXcel Therapeutics advances clinical programs and secures financial backing

BioXcel Therapeutics showcased progress in clinical programs and financial flexibility, with a focus on Alzheimer's-related opportunities.
Challenges include ongoing safety discussions, cash burn rate management, and logistical complexities in home setting trials.
Opportunities lie in targeting underserved markets, regulatory support, economic alleviation for hospitals, and efficient program advancement.
Balancing financial strategies and ensuring data integrity and regulatory alignment are key priorities for BioXcel's future success.

BioXcel Therapeutics reports strong Q4 results and advances clinical programs

BioXcel Therapeutics showcased positive financial performance and progress in late-stage clinical programs, indicating a promising outlook for the company's future.
While facing challenges such as trial timing reevaluation and funding uncertainties, the company's proactive approach and strategic focus present opportunities for growth and innovation.
By leveraging its strengths in program development and financial planning, BioXcel Therapeutics can navigate challenges and capitalize on opportunities to drive value for stakeholders.

BioXcel Therapeutics reports robust Q1 performance and advances late-stage programs

BioXcel Therapeutics demonstrated strong financial performance in Q1 2024, with notable revenue growth and reduced net losses. The company's focus on expanding market potential, advancing late-stage programs, and strengthening intellectual property positions it well for future growth. Challenges include sustaining commercialization success and managing expenses effectively.

BioXcel Therapeutics excels in Q2 with strong financial and clinical performance

BioXcel Therapeutics demonstrated strong financial and clinical performance in Q2 2024, with revenue growth, reduced expenses, and promising outcomes in key programs.
The company's strategic focus on expanding into home settings, addressing unmet needs, and exploring innovative therapies positions it well for sustained growth and value creation.
While facing challenges in execution and financial management, BioXcel Therapeutics has opportunities to leverage its strengths, drive innovation, and establish market leadership in mental health treatment.

BioXcel Therapeutics advances pivotal trials amidst financial challenges

BioXcel Therapeutics made notable progress in its clinical trials and received positive feedback from the FDA, indicating a strong focus on innovation and regulatory compliance.
While facing financial challenges with a net loss in Q3 2024, the company demonstrated cost management efforts through reduced expenses.
The company's ability to secure grants and maintain a healthy cash position positions it well to capitalize on opportunities for growth and development in the mental health therapeutics market.

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BioXcel Therapeutics, Inc. is a biopharmaceutical company, which engages in the development of artificial intelligence solutions in neuroscience and immuno-oncology. It also focuses on utilizing technology and research to develop therapeutics solutions. The company was founded by Vimal D. Mehta on March 29, 2017 and is headquartered in New Haven, CT.

NEW HAVEN, Conn., March 04, 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 it will host a conference call and webcast on Thursday, March 11, 2021 at 8:30 AM Eastern Time to discuss its fourth quarter and full year 2020 operating and financial results.

BioXcel Therapeutics to Host Fourth Quarter and Full Year 2020 Operating and Financial Results Conference Call and Webcast

BioXcel Therapeutics Inc (NASDAQ: BTAI) plans to finalize study design, dosing, and endpoints for its BXCL501 Phase 3 program in dementia-related agitation. The end of the Phase 2 meeting with the FDA is scheduled in Q2 2021.

BioXcel's BXCL501 Lower Dose Shows Statistical Significance On Agitation Scales

Review of TRANQUILITY data show ed 30 mcg dose met statistical significance across multiple scales

BioXcel Therapeutics Provides Update on its BXCL501 Program for the Acute Treatment of Dementia Related Agitation

Former Allergan executive brings extensive global regulatory experience across multiple therapeutic areas Former Allergan executive brings extensive global regulatory experience across multiple therapeutic areas

BioXcel Therapeutics Appoints June Bray to Board of Directors

BioXcel Therapeutics Inc (NASDAQ: BTAI) initiated the Phase 2 PLACIDITY trial evaluating BXCL501 to treat delirium-related agitation. The 20 subject-trial is designed to evaluate the safety, efficacy, and pharmacokinetics of BXCL501 in intensive care unit adult patients experiencing delirium-related agitation, including COVID-19 patients.

BioXcel Therapeutics Starts Testing BXCL501 In Mid-Stage Delirium-Related Agitation Study

NEW HAVEN, Conn., Feb. 23, 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 the appointment of Javier Rodriguez as Senior Vice President, Chief Legal Officer and Corporate Secretary, effective immediately. Mr. Rodriguez will report to Chief Executive Officer, Vimal Mehta and joins BioXcel with 20 years of extensive strategic and legal experience within the biopharmaceutical industry.

BioXcel Therapeutics Appoints Javier Rodriguez as Chief Legal Officer and Corporate Secretary

Live webcast to be held on February 19th from 11:00 am ET to 2:00 pm ET Live webcast to be held on February 19th from 11:00 am ET to 2:00 pm ET

BioXcel Therapeutics to Host Virtual Key Opinion Leader Event to Highlight BXCL501 as a Potential Treatment for Agitation and Opioid Withdrawal Symptoms

NEW HAVEN, Conn., Feb. 04, 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 that an update from its ongoing Phase 1b/2 trial of BXCL701, the Company's investigational, oral innate immunity activator, in aggressive forms of prostate cancer will be presented in a poster session at the virtual 2021 ASCO Genitourinary ("ASCO GU") Cancers Symposium. ASCO GU is being held from Thursday, February 11, 2021 to Saturday, February 13, 2021.

BioXcel Therapeutics to Present an Update from its Ongoing Trial of BXCL701 in Aggressive Forms of Prostate Cancer at the 2021 ASCO Genitourinary Cancers Symposium

A Wall Street analyst has high hopes for the company.

Why BioXcel Therapeutics Stock Popped Today

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BioXcel uses a proprietary AI program to screen for ways to repurpose old drugs and screen for useful biomarkers that can allow for faster, safer, and cheaper drug development. BioXcel's lead asset BXCL501 is targeting a broad swath of agitation-related indications that could be very lucrative for the company.

BioXcel Therapeutics Has Compelling Upside Potential In Advance Of Multiple Data Readouts

Company to present corporate update and plans for 2021

BioXcel Therapeutics to Present at the 39th Annual J.P. Morgan Healthcare Conference

Grant will support clinical studies in patients with post-traumatic stress disorder related to alcohol and substance abuse Grant will support clinical studies in patients with post-traumatic stress disorder related to alcohol and substance abuse

BioXcel Therapeutics Announces Grant by U.S. Department of Defense to Evaluate BXCL501 in Patients Suffering from PTSD

NEW HAVEN, Conn., Nov. 13, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced that Dr. Vimal Mehta, Founder and Chief Executive Officer of BTI, will participate in a fireside chat at the Jefferies Virtual London Healthcare Conference.

BioXcel Therapeutics to Participate in the Jefferies Virtual London Healthcare Conference

BioXcel Therapeutics, Inc. (BTAI) CEO Vimal Mehta on Q3 2020 Results - Earnings Call Transcript

Complete NDA submission for BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorders on track for Q1 2021

BioXcel Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update

Initiated rolling submission of New Drug Application (“NDA”) with U.S. Food and Drug Administration (“FDA”)

BioXcel Therapeutics Announces Completion of Pre-NDA Meeting with FDA for BXCL501 for the Acute Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorders

Encouraging signals of activity in difficult-to-treat tumors observed in both ongoing trials with BXCL701 and pembrolizumab (KEYTRUDA®)

BioXcel Therapeutics to Present BXCL701 Clinical Data at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting

NEW HAVEN, Conn., Nov. 05, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced it will host a conference call and webcast on Thursday, November 12, 2020 at 8:30 AM Eastern Time to discuss its third quarter 2020 operating and financial results.

BioXcel Therapeutics to Host Third Quarter 2020 Operating and Financial Results Conference Call and Webcast

Fifth potential indication for BXCL501, an orally dissolving thin film Fifth potential indication for BXCL501, an orally dissolving thin film

BioXcel Therapeutics Receives FDA Clearance of IND for Phase 2 Trial with BXCL501 for the Treatment of Agitation Associated with Delirium

BioXcel product candidates use the 505(b)(2) approval pathway. Successful pivotal trials for two indications in acute agitation.

BioXcel: Banking On The 505(B)(2) NDA Pathway

Today, we look at a promising CNS play called BioXcel Therapeutics. The shares have lost more than a third from their pre-secondary offering highs.

BioXcel Therapeutics: Big Upside Potential

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BioXcel Therapeutics: Opportunity Emerges During Pandemic While Mental Health Is Being Ignored

NEW HAVEN, Conn., Sept.  09, 2020  (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced that Dr. Vimal Mehta, Founder and Chief Executive Officer of BTI, will present at the H.C. Wainwright 22nd Annual Global Investment Conference.

News for BioXcel Therapeutics Stock (BTAI)