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.

BXCL501 demonstrated statistically significant and clinically meaningful improvements in primary and key secondary efficacy measures compared with placebo

BioXcel Therapeutics Announces Journal of the American Medical Association Publication of Data from SERENITY II Pivotal Phase 3 Trial Evaluating BXCL501 in Bipolar Disorders

BXCL701 plus KEYTRUDA® (pembrolizumab) demonstrates encouraging composite response rates in SCNC (33%) and adenocarcinoma (21%) cohorts

BioXcel Therapeutics Presents Positive Data from Phase 2 Trial of BXCL701 in Aggressive Forms of Prostate Cancer at 2022 ASCO Genitourinary Cancers Symposium

NEW HAVEN, Conn., Feb. 09, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vimal Mehta, Ph.D., Founder and Chief Executive Officer, will present at the upcoming SVB Leerink 11th Annual Global Healthcare Conference on Wednesday, February 16 at 2:20 p.m. ET. Dr. Mehta will highlight the Company's neuroscience and immuno-oncology programs, artificial intelligence platform used to augment and accelerate the drug candidate discovery and development process, and its commercial and launch readiness plans for BXCL501.

BioXcel Therapeutics to Present at the SVB Leerink 11th Annual Global Healthcare Conference

In 2022, BioXcel may become a commercial-stage company for the first time in its history.

BioXcel Therapeutics: Facing An Important PDUFA Date In A Few Weeks

NEW HAVEN, Conn., Jan. 19, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (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 Matt Wiley as Senior Vice President and Chief Commercial Officer (CCO).

BioXcel Therapeutics Appoints Matt Wiley Chief Commercial Officer

NEW HAVEN, Conn., Jan. 04, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, will present corporate updates and plans for 2022 at the 40th Annual J.P. Morgan Healthcare Conference, being held virtually, on Thursday, January 13, 2022 at 9:45 a.m. ET.

BioXcel Therapeutics to Present at the 40th Annual J.P. Morgan Healthcare Conference

Two Phase 3 studies to enroll a total of 300 patients in assisted living or residential facilities and nursing homes to evaluate the safety and efficacy of BXCL501

BioXcel Therapeutics Initiates Pivotal Phase 3 Program of BXCL501 for Acute Treatment of Agitation in Patients with Alzheimer's Disease

The FDA extended BTAI's PDUFA by three months, tanking the stock.

BioXcel: Slump After PDUFA Extension Presents Buying Opportunity

A regulatory delay is weighing on the biotech today.

Why BioXcel Therapeutics Stock Is Slumping Today

The stock price of BioXcel Therapeutics, Inc. (Nasdaq: BTAI) fell by over 18% pre-market today. This is why it happened.

BioXcel Therapeutics (BTAI) Stock: Why The Price Substantially Fell Today

PDUFA date extended by three months to April 5, 2022

BioXcel Therapeutics Announces Extension of FDA Review Period of its NDA for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders

A double downgrade from an analyst on Wall Street is causing investors to think twice about the company's first new drug launch.

Why BioXcel Therapeutics Is Down Sharply This Week

Why BioXcel Therapeutics Stock Is Crashing Today

NEW HAVEN, Conn., Nov. 11, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vimal Mehta, Ph.D., Founder and Chief Executive Officer, and Frank Yocca, Ph.D., Chief Scientific Officer , will participate in a fireside chat at the 12th Annual Jefferies Global Healthcare Conference in London on Wednesday, November 17, 2021 at 4:20 p.m. GMT / 11:20 a.m. ET. Dr. Mehta and Dr. Yocca will highlight the Company's neuroscience and immune-oncology programs, artificial intelligence platform used to augment and accelerate the drug candidate discovery and development process, and its commercial and launch readiness plans for BXCL501.

BioXcel Therapeutics to Present at the 2021 Jefferies London Healthcare Conference

BioXcel Therapeutics, Inc. (BTAI) CEO Vimal Mehta on Q3 2021 Results - Earnings Call Transcript

Plans for commercial and launch readiness advancing for BXCL501 orally dissolving film, for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, ahead of January 5, 2022 PDUFA date

BioXcel Therapeutics Reports Third Quarter 2021 Financial Results and Recent Operational Highlights

NEW HAVEN, Conn., Oct. 27, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release its third quarter 2021 financial results on Wednesday, November 10, 2021 before the open of the U.S. financial markets. BioXcel Therapeutics' management team will also host a conference call and webcast at 8:30 AM ET to discuss the Company's financial results and to provide a general business update.

BioXcel Therapeutics to Report Third Quarter 2021 Financial Results on November 10, 2021

The company intends to expand the indication of BXCL501 to treat anxious depression.

BioXcel Therapeutics: Ready To Enter The Depression Therapeutic Field

After a difficult year, shares of this biotech could bounce back big.

This High-Risk, High-Reward Stock Might Double Your Money

Initial findings from Phase 1b/2 trial of BXCL701 in combination with KEYTRUDA met efficacy threshold to support expansion of existing cohort of de novo and treatment-emergent Small-Cell Neuroendocrine Prostate Cancer (SCNC)

BioXcel Therapeutics Announces Expansion of Phase 2 Trial of BXCL701 in De Novo and Treatment-Emergent Small-Cell Neuroendocrine Prostate Cancer

The company's chief commercial officer resigned.

Why BioXcel Therapeutics Stock Is Sinking Today

Management to showcase AI platform to develop potential treatments for neuropsychiatric disorders

BioXcel Therapeutics to Highlight Novel Approaches in AI-Based Drug Candidate Discovery and Development and Advances in Neuroscience Portfolio at Virtual R&D Day

BXCL701 plus KEYTRUDA® (pembrolizumab) demonstrates encouraging anti-tumor activity in heavily pre-treated mCRPC patients with adenocarcinoma

BioXcel Therapeutics Presents Results from Ongoing Phase 2 Trial of BXCL701 in Combination with KEYTRUDA® in Aggressive Forms of Prostate Cancer at ESMO

NEW HAVEN, Conn., Sept. 12, 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 updates 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 2021 European Society for Medical Oncology (ESMO) Congress, which will take place virtually from September 16-21, 2021.

BioXcel Therapeutics to Present Updates from Ongoing Trial of BXCL701 in Aggressive Forms of Prostate Cancer at 2021 ESMO Congress

Live webcast, Revolutionizing Drug Discovery and Development Through AI, to be held from 12:00 PM ET – 2:00 PM ET

News for BioXcel Therapeutics Stock (BTAI)