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.

BioXcel Therapeutics' (BTAI) CEO Vimal Mehta on Q2 2020 Results - Earnings Call Transcript

Investors were not impressed with the company's latest quarterly update.

Why BioXcel Therapeutics Stock Is Down Today

SERENITY I & II Phase 3 trials of BXCL501 achieved all primary and secondary endpoints; New Drug Application (“NDA”) submission to U.S. Food and Drug Administration (“FDA”) planned for Q1 2021

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

NEW HAVEN, Conn., Aug.  07, 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 Friday, August 14, 2020 at 8:30 AM Eastern Time to discuss its second quarter 2020 operating and financial results.

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

The company reported positive results from two pivotal clinical trials.

Why BioXcel Therapeutics Is Soaring Today

Bioxcel Therapeutics unveiled bullish Phase 3 results for an agitation treatment in patients with schizophrenia and bipolar disorder Monday — pushing BTAI stock to a record high.
The post Bioxcel Therapeutics Hits Record On Bullish Test Results In Schizophrenia appeared first on Investor's Business Daily.

Bioxcel Therapeutics Hits Record On Bullish Test Results In Schizophrenia

Highly statistically significant improvements in PEC score observed vs. placebo (p

BioXcel Therapeutics Announces Primary and Secondary Endpoints Met in Two Pivotal Phase 3 Trials of BXCL501 for the Acute Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorder

Company providing BXCL501 to evaluate its activity in patients with COVID-19 that may require calming or arousable sedation following intubation Company providing BXCL501 to evaluate its activity in patients with COVID-19 that may require calming or arousable sedation following intubation

BioXcel Therapeutics Announces Compassionate Use Program at Massachusetts General Hospital for BXCL501 to Treat COVID-19 Patients Suffering from Delirium and Agitation

Patent is expected to extend IP protection until 2039 Patent is expected to extend IP protection until 2039

BioXcel Therapeutics Announces Notice of Allowance for U.S. Patent Application Covering Formulation for BXCL501 and Methods of Treating Agitation

Will lead global clinical development strategy and medical affairs for the Company’s neuroscience programs Will lead global clinical development strategy and medical affairs for the Company’s neuroscience programs

BioXcel Therapeutics Announces Appointment of Reina Benabou, M.D., Ph.D., as Chief Development Officer

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Former Allergan Commercial Head to lead commercialization efforts for BXCL501 across multiple neuropsychiatric disorders Former Allergan Commercial Head to lead commercialization efforts for BXCL501 across multiple neuropsychiatric disorders

BioXcel Therapeutics Announces Appointment of William P. Kane as Chief Commercial Officer

NEW HAVEN, Conn., June  15, 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 fireside chats at two upcoming virtual investor conferences.

BioXcel Therapeutics to Participate in Two Upcoming Investor Conferences

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Topline results expected in the first quarter of 2021 Topline results expected in the first quarter of 2021

BioXcel Therapeutics Announces First Patient Enrolled in Phase 1b/2 RELEASE Trial of BXCL501 for the Treatment of Opioid Withdrawal Symptoms

Topline results, expected in July of 2020, are intended to support a New Drug Application filing Topline results, expected in July of 2020, are intended to support a New Drug Application filing

BioXcel Therapeutics Announces Completion of Patient Enrollment in Phase 3 SERENITY Trials with BXCL501

BioXcel Therapeutics, Inc. (BTAI) CEO Vimal Mehta on Q1 2020 Results - Earnings Call Transcript

 Enrollment of the pivotal SERENITY trials is progressing well, with topline data expected in mid-2020

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

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BioXcel Therapeutics (NASDAQ: BTAI) founder and CEO Dr. Mehta Vimal spoke with Benzinga about its BXCL-501 drug candidate for agitation in Alzheimer's patients — and how it relates to wearable devices.

BioXcel Therapeutics CEO Says Wearable Devices Are Another Tool To Combat Alzheimer's Agitation

More than one-third of the SERENITY I & II patients have been dosed, including over 100 bipolar patients

BioXcel Therapeutics Provides an Update on its Ongoing Phase 3 SERENITY Trials

Unlike much of the market, BioXcel Therapeutics is actually up year to date.

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BioXcel Therapeutics, Inc. (BTAI) CEO Vimal Mehta on Q4 2019 Results - Earnings Call Transcript

Key BXCL501 data readouts expected in mid-2020 – including results from the SERENITY program and the Phase 1b/2 TRANQUILITY trial in geriatric dementia

BioXcel Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update

Shares tumble after the company announces that it is raising capital.

News for BioXcel Therapeutics Stock (BTAI)