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, Inc. (BTAI) CEO Dr. Vimal Mehta on Q2 2021 Results - Earnings Call Transcript

Phase 3 study of BXCL501 for the acute treatment of agitation associated with dementia expected to begin in Q4 2021

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

Biogen

Want to dabble in the market for Alzheimer's therapies but avoid Biogen? Look no further.

This Under-the-Radar Dementia Treatment Could Reward Investors

NEW HAVEN, Conn., July 28, 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 release its second quarter 2021 financial results on Tuesday, August 10, 2021 before the open of the U.S. financial markets. BioXcel's management team will also host a conference call and webcast at 8:30 AM EDT to discuss the Company's financial results and to provide a general business update.

BioXcel Therapeutics to Report Second Quarter 2021 Financial Results on August 10, 2021

NEW HAVEN, Conn., July 19, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (Nasdaq: BTAI), today announced that Dr. Vimal Mehta, Ph.D., Founder and Chief Executive Officer of BioXcel, will participate in the Canaccord Genuity 41st Annual Growth Conference on Thursday, August 12, 2021 at 9:30 a.m. Eastern Time.

BioXcel Therapeutics to Present at Canaccord Genuity 41st Annual Growth Conference

Investors weren't happy about a secondary share offering.

Here's Why BioXcel Therapeutics Stock Got Hammered This Week

NEW HAVEN, Conn., June 23, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical development company, today announced the pricing of an underwritten public offering of 3,155,000 shares of common stock at a public offering price of $31.70 per share. In addition, a related party stockholder, BioXcel LLC, has granted the underwriters a 30-day option to purchase up to an additional 473,250 shares of common stock at the public offering price, less underwriting discounts and commissions. Gross proceeds to the Company from the offering are expected to be approximately $100.0 million, before deducting underwriting discounts and commissions and offering expenses. The Company will not receive any of the proceeds from any sale of shares in this offering by BioXcel LLC.

BioXcel Therapeutics Announces Pricing of Public Offering of Common Stock

NEW HAVEN, Conn., June 22, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (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 it has commenced an underwritten public offering of $100.0 million of shares of its common stock. In addition, a related party stockholder, BioXcel LLC, expects to grant the underwriters a 30-day option to purchase up to $15.0 million of additional shares of common stock at the public offering price, less underwriting discounts and commissions.

BioXcel Therapeutics Announces Proposed Public Offering of Common Stock

Live webcast to be held on June 25th from 12:00 PM ET – 1:30 PM ET Live webcast to be held on June 25th from 12:00 PM ET – 1:30 PM ET

BioXcel Therapeutics to Host Virtual Commercial Day on June 25, 2021

BioXcel has a January 5 PDUFA for its lead candidate. The stock is down strongly.

BioXcel: Upcoming PDUFA Makes Recent Drop Attractive

The FDA has accepted for review, BioXcel Therapeutics Inc's (NASDAQ: BTAI) marketing application for BXCL501, an orally dissolving thin film formulation of dexmedetomidine. The application covers the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II.

BioXcel's Formulated Dexmedetomidine US Application For Agitation Under FDA Review

FDA sets PDUFA action date for January 5, 2022

BioXcel Therapeutics Announces FDA Acceptance for Filing of NDA for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders I and II

BioXcel Therapeutics, Inc. (BTAI) CEO Vimal Mehta on Q1 2021 Results - Earnings Call Transcript

Granted FDA Breakthrough Therapy designation for BXCL501 for the acute treatment of agitation associated with dementia; registrational program expected to begin in 2H 2021

BioXcel Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update

NEW HAVEN, Conn., May 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 Dr. Vimal Mehta, Founder and Chief Executive Officer of BioXcel, will participate in two upcoming virtual healthcare investor conferences.

BioXcel Therapeutics to Participate in Two Upcoming Healthcare Investor Conferences

NEW HAVEN, Conn., May 03, 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 Monday, May 10, 2021 at 8:30 AM Eastern Time to discuss its first quarter 2021 operating and financial results.

BioXcel Therapeutics to Host First Quarter 2021 Operating and Financial Results Conference Call and Webcast

NEW HAVEN, Conn., April 26, 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 data from its two pivotal Phase 3 trials (SERENITY I & II) of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II will be presented at the upcoming American Psychiatric Association (“APA”) Annual Meeting. The meeting will be held virtually on May 1-3, 2021.

BioXcel Therapeutics Announces Presentations on SERENITY I & II at the 2021 American Psychiatric Association Annual Meeting

New York, New York--(Newsfile Corp. - April 16, 2021) - Levi & Korsinsky announces it has commenced an investigation of BioXcel Therapeutics, Inc. (NASDAQ: BTAI) concerning possible breaches of fiduciary duty. To obtain additional information, go to:https://www.zlk.com/compensation2/bioxcel-therapeutics-inc-information-request-form or contact Joseph E. Levi, Esq. either via email at jlevi@levikorsinsky.com or by telephone at (212) 363-7500. There is no cost or obligation to you.

SHAREHOLDER ALERT: Levi & Korsinsky, LLP Notifies Shareholders of an Investigation Concerning Possible Breaches of Fiduciary Duty by Certain Officers and Directors of BioXcel Therapeutics, Inc. (BTAI)

Investors were not impressed with the biotech's latest clinical update.

Why BioXcel Therapeutics Stock Is Plunging Today

BioXcel Therapeutics Inc (NASDAQ: BTAI) has announced topline results from its Phase 1b/2 proof-of-concept RELEASE study evaluating BXCL501 for the treatment of opioid withdrawal symptoms. BXCL501 is the Company's proprietary, orally dissolving thin film formulation of dexmedetomidine.

BioXcel Stock Is Trading Lower After BXCL501 Data In Opioid Withdrawal Study

Primary safety endpoint achieved in first study of BXCL501 dosed twice-daily over seven days

BioXcel Therapeutics Announces Results of Phase 1b/2 Study of BXCL501 for the Treatment of Opioid Withdrawal Symptoms

The FDA has designated Breakthrough Therapy status to BioXcel Therapeutics Inc's (NASDAQ: BTAI) BXCL501, to treat agitation associated with dementia. The designation intends to expedite the development and review of certain product candidates.

FDA Gives Accelerated Review Tag To BioXcel's BXCL501 In Dementia-Related Agitation

Designation offers the potential for expedited development and review, highlighting the urgent need for new treatment options for dementia related agitation Designation offers the potential for expedited development and review, highlighting the urgent need for new treatment options for dementia related agitation

BioXcel Therapeutics Receives FDA Breakthrough Therapy Designation for BXCL501 for the Acute Treatment of Agitation Associated with Dementia

BioXcel Therapeutics, Inc. (BTAI) CEO Vimal Mehta on Q4 2020 Results - Earnings Call Transcript

New Drug Application (“NDA”) submitted to the U.S. Food and Drug Administration (“FDA”) for BXCL501 for the acute treatment of schizophrenia and bipolar disorder related agitation

News for BioXcel Therapeutics Stock (BTAI)