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.

With the company's launch of its first marketed drug on the horizon, investors showed some excitement.

Why Shares of BioXcel Therapeutics Climbed 25.2% This Week

BioXcel Therapeutics Inc. (NASDAQ:BTAI ) Q1 2022 Earnings Conference Call May 9, 2022 8:30 AM ET Company Participants Vimal Mehta - Chief Executive Officer Matt Wiley - Chief Commercial Officer Richard Steinhart - Vice President, Chief Financial Officer Rob Risinger - Chief Medical Officer, Neuroscience Conference Call Participants Greg Harrison - Bank of America Robyn Karnauskas - Truist Securities Sumant Kulkarni - Canaccord Yatin Suneja - Guggenheim Partners Colin Bristow - UBS Corinne Jenkins - Goldman Sachs Anita Dushyanth - Berenberg Operator Good morning and welcome to the BioXcel Therapeutics first quarter 2022 financial results conference call. At this time, all participants are in a listen-only mode.

BioXcel Therapeutics (BTAI) CEO, Vimal Mehta on Q1 2022 Results - Earnings Call Transcript

Received FDA approval of IGALMI™ (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults

BioXcel Therapeutics Reports First Quarter 2022 Financial Results and Recent Operational Highlights

The company is stepping up its efforts to expand the label uses of its lead therapy.

Why BioXcel Therapeutics Shares Went Up 12.9% This Week

NEW HAVEN, Conn., May 05, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-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 participate in three upcoming investor conferences. Dr. Mehta will highlight the Company's neuroscience and immuno-oncology programs as well as its artificial intelligence platform used to augment and accelerate the drug candidate discovery and development process. He will also discuss the Company's commercial and launch readiness plans for IGALMI™ (dexmedetomidine) sublingual film.

BioXcel Therapeutics to Present at Three Upcoming Investor Conferences

Top-line data for TRANQUILITY II anticipated in Q4 2022/early Q1 2023

BioXcel Therapeutics Announces First Patient Dosed in TRANQUILITY II Phase 3 Trial for Acute Treatment of Agitation in Patients with Alzheimer's Disease

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NEW HAVEN, Conn., April 26, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence (AI) approaches to identify and develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release its first quarter 2022 financial results on Monday, May 9, 2022 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 First Quarter 2022 Financial Results on May 9, 2022

OnkosXcel, a Company subsidiary, to utilize proprietary AI-powered platform to progress therapies to address difficult-to-treat cancers with high unmet need

BioXcel Therapeutics Announces Formation of OnkosXcel Therapeutics to Develop Medicines Focused in Oncology

Investment will support upcoming U.S. commercial launch activities of IGALMI™ and further clinical pipeline development

BioXcel Therapeutics Announces $260 Million Strategic Financing with Oaktree and Qatar Investment Authority

On April 6, BioXcel announced the FDA's approval of BXCL501 to treat acute agitation in patients with schizophrenia and bipolar syndrome.

BioXcel Therapeutics: At A Turning Point After The Approval Of BXCL501

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BioXcel Therapeutics Inc (NASDAQ: BTAI) shares are trading higher Wednesday after the company announced that the U.S. Food and Drug Administration approved IGALMI (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in.

Why BioXcel Therapeutics Stock Is Surging Today

Shares of BioXcel Therapeutics Inc. BTAI, -2.98% jumped 14.6% in premarket trading on Wednesday after the company said the Food and Drug Administration approved Igalmi, a sublingual film used to treat agitation associated with schizophrenia or bipolar disorder in adults. The therapy is expected to launch in the U.S. in the second quarter of this year.

BioXcel says the FDA approved its therapy for adults with schizophrenia or bipolar disorder

First and only FDA-approved orally dissolving sublingual film for mild, moderate or severe agitation in patients with schizophrenia or bipolar I or II disorder 1

BioXcel Therapeutics Announces FDA Approval of IGALMI™ (dexmedetomidine) Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults

Investors may be anticipating a positive review by the FDA of the company's lead drug candidate.

Why Shares of BioXcel Therapeutics Shot Up 25.4% This Week

We are initiating coverage on BTAI with a target price of USD 126 (+600% potential upside) and a potential 60% downside (~$7 cash value). We like the risk-reward set-up for the company.

BioXcel Therapeutics Inc.: Speculative Buy To Play The PDUFA For BXCL501 In April

BioXcel Therapeutics, Inc. (BTAI) CEO Vimal Mehta on Q4 2021 Results - Earnings Call Transcript

Ready to launch BXCL501 upon approval as Company nears April 5, 2022 PDUFA action date

BioXcel Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Operational Highlights

NEW HAVEN, Conn., March 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 Barclays Global Healthcare Conference on Tuesday, March 15 at 3:50 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 its product candidate, BXCL501.

BioXcel Therapeutics to Present at the Barclays Global Healthcare Conference

BioXcel Therapeutics faces its first PDUFA on April 5.

Bioxcel Therapeutics: What To Expect From The Upcoming PDFA

NEW HAVEN, Conn., Feb. 24, 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 it will release its fourth quarter and full year 2021 financial results on Thursday, March 10, 2022 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 Fourth Quarter and Full Year 2021 Financial Results on March 10, 2022

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

News for BioXcel Therapeutics Stock (BTAI)