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.

Provides update on two late-stage clinical programs for BXCL501 for potential treatment of agitation Recently completed meetings with U.S. Food and Drug Administration for TRANQUILITY and SERENITY programs C onference call and webcast set for 8:00 a.m. ET today NEW HAVEN, Conn.

BioXcel Therapeutics Reports Financial Results for the Fourth Quarter and Full Year 2023

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NEW HAVEN, Conn., March 01, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release its fourth quarter and full year 2023 financial results on Tues., March 12, 2024, before the open of the U.S. financial markets. BioXcel Therapeutics' management team will also host a conference call and webcast at 8:00 AM ET that day to discuss the Company's financial results and provide a general business update.

BioXcel Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results on March 12, 2024

NEW HAVEN, Conn., Feb. 13, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that it has terminated its proposed public offering of $60.0 million of shares of its common stock or, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock, previously announced on February 8, 2024. As a result of such termination, no securities of the Company are being sold pursuant to the offering.

BioXcel Therapeutics Announces Termination of Proposed Public Offering

Designation for BXCL701 in combination with a checkpoint inhibitor (CPI) for treatment of patients with metastatic SCNC with progression on chemotherapy and no evidence of microsatellite instability

BioXcel Therapeutics Receives FDA Fast Track Designation for BXCL701 for Treatment of Small Cell Neuroendocrine Prostate Cancer (SCNC)

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BioXcel Therapeutics (NASDAQ: BTAI ) stock is taking a beating on Friday after the commercial-stage biopharmaceutical company announced a proposed underwritten public offering for its shares. This public offering includes $60 million shares of BTAI stock.

Why Is BioXcel Therapeutics (BTAI) Stock Down 26% Today?

Human proof of concept portion of the trial expected to begin in H1 2024; led by Georgetown Lombardi Comprehensive Cancer Center

BioXcel Therapeutics Announces Completion of Patient Enrollment in Safety Portion of Investigator-Sponsored Phase 2 Relapsed Pancreatic Cancer Trial of BXCL701 in Combination with KEYTRUDA®

Aligns with Company's strategic focus on bringing to market BXCL501 for potential acute treatment of agitation for Alzheimer's patients

BioXcel Therapeutics Announces USPTO's Allowance of Patent Application for Method of Treating Agitation in Alzheimer's Disease Using Oromucosal Formulations of Dexmedetomidine

Company to review BXCL502 and other potential emerging pipeline candidates   Dr. Jeffrey Cummings to discuss agitation relief in Alzheimer's disease and BXCL502 as a potential treatment for chronic use Dr. Sandra Comer to discuss BXCL501 as a potential treatment for opioid withdrawal NEW HAVEN, Conn., Dec. 12, 2023 (GLOBE NEWSWIRE) -- As previously announced, BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, will host a virtual Neuroscience R&D Day focused on BXCL502 and other neuroscience pipeline candidates.

BioXcel Therapeutics Hosting Virtual Neuroscience R&D Day Today

Vincent J. O'Neill, M.D., promoted to Executive Vice President, Chief of Product Development and Medical Officer   Rajiv Patni, M.D.

BioXcel Therapeutics Strengthens Clinical Development Leadership to Advance Late-Stage Programs

Company to review BXCL502 and other potential emerging pipeline candidates   Dr. Jeffrey Cummings to discuss agitation relief in Alzheimer's disease and BXCL502 as a potential treatment Dr. Sandra Comer to discuss BXCL501 as a potential treatment for opioid withdrawal  NEW HAVEN, Conn., Nov. 30, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will host a virtual Neuroscience R&D Day from 1:00 to 2:30 p.m.

BioXcel Therapeutics to Host Virtual Neuroscience R&D Day on Dec. 12, 2023

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BioXcel Therapeutics Inc (NASDAQ:BTAI) shares fell almost 35% after it reported a revenue miss and greater than forecast loss for the third quarter. The New Haven, Connecticut-based biopharmaceutical company reported sales of $341,000, up from $137,000 in the year-ago quarter but below estimates of $840,000.

BioXcel Therapeutics stock plummets as 3Q earnings fall short of expectations

BioXcel Therapeutics, Inc. (BTAI) Q3 2023 Earnings Call Transcript

Company plans to conduct Phase 3 trial of BXCL501 in the at-home setting for TRANQUILITY program to support potential sNDA for acute treatment of agitation associated with dementia due to probable Alzheimer's disease

BioXcel Therapeutics Aligns with FDA Recommendation for Phase 3 Trial for TRANQUILITY Program, Provides Update on Strategic Financing, and Reports Third Quarter 2023 Financial Results

Median overall survival of 15.5 months with BXCL701 + KEYTRUDA® (pembrolizumab),  compared to 9.6 months with checkpoint inhibitor monotherapy in late-line refractory patients in separate Phase 2 trial 1

BioXcel Therapeutics Reports Positive Overall Survival Results from Single-Arm, Open-Label Phase 2 Trial of BXCL701 in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) of Adenocarcinoma Phenotype

Columbia University-led trial expected to add fourth site to target completion of 4-arm, 160-patient trial in 2024 Fentanyl adulterated or associated with xylazine (FAAX) designated an emerging threat by the White House Office of National Drug Control Policy 1 Company to seek FDA feedback on potential registrational paths NEW HAVEN, Conn., Nov. 06, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced an update on the National Institute on Drug Abuse (NIDA)-funded trial evaluating BXCL501 (sublingual dexmedetomidine) as a potential treatment for opioid use disorder (OUD).

BioXcel Therapeutics Announces Update on NIDA-funded Trial of BXCL501 (sublingual dexmedetomidine) for Potential Treatment of Opioid Use Disorder (OUD)

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NEW HAVEN, Conn., Oct. 31, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it will release its third quarter 2023 financial results on Tuesday, November 14, 2023 before the open of the U.S. financial markets. BioXcel Therapeutics' management team will also host a conference call and webcast at 8:00 AM ET that day to discuss the Company's financial results and to provide a general business update.

BioXcel Therapeutics to Report Third Quarter 2023 Financial Results on November 14, 2023

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Standardizes and improves product reimbursement process New HCPCS Level II code J1105 to be effective January 1, 2024 NEW HAVEN, Conn., Oct. 30, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that the Centers for Medicare & Medicaid Services (CMS) has issued a permanent and product-specific J-Code for IGALMI™ (dexmedetomidine) sublingual film, which is approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults1,2.

BioXcel Therapeutics Receives Permanent J-Code for IGALMI™ (dexmedetomidine) Sublingual Film from Centers for Medicare & Medicaid Services

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BioXcel Therapeutics Inc (NASDAQ:BTAI) shares rallied on Wednesday after the artificial intelligence (AI)-powered biopharmaceutical company reported that an independent audit of a site in its late-stage trial of its investigational therapeutic BXCL501 to treat agitation in Alzheimer's patients found no evidence of misconduct or fraud beyond what has already been reported. In June 2023, the company flagged issues around the recording of safety data at a site in its TRANQUILITY II Phase 3 trial, specifically that a principal investigator may have fabricated emails showing that they submitted certain safety data in a timely manner.

News for BioXcel Therapeutics Stock (BTAI)