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 got approval last year for Igalmi to treat acute agitation in adults with schizophrenia or bipolar disorder. The drug is in a trial to treat patients in an at-home setting.

Why Shares of BioXcel Therapeutics Are Dropping Thursday

Shares of BTAI stock plummeted after BioXcel's Igalmi missed the mark in patients with agitation due to schizophrenia or bipolar disorders. The post BioXcel Stock Crashes 22% As Bid To Double Its Market Appears Less Certain appeared first on Investor's Business Daily.

BioXcel Stock Crashes 22% As Bid To Double Its Market Appears Less Certain

Clinically meaningful efficacy results observed with half (60mcg) of the approved dose of IGALMI™ Greater than 50% PEC response rate attained; proportionally consistent with dose response when compared to rates seen in SERENITY I and II BXCL501 was well tolerated and demonstrated favorable safety results supporting potential for at-home use SERENITY III Part 2 planned as an adaptive trial design with 60mcg and 80mcg to potentially address agitation spectrum for patients at home Company to hold conference today at 8 a.m. ET  NEW HAVEN, Conn.

BioXcel Therapeutics Announces Promising Topline Results from Part 1 of Pivotal SERENITY III Trial of BXCL501 for At-Home Use in Acute Treatment of Agitation in Bipolar Disorders or Schizophrenia

BXCL501 was well tolerated across a broad dose range from 30mcg to 140mcg administered chronically  Planning Phase 2 human proof-of-concept study to evaluate BXCL501 as a potential adjunctive treatment in MDD Data further supportive of ongoing clinical programs evaluating BXCL501 for potential at-home use for agitation associated with schizophrenia or bipolar disorders (SERENITY III) and agitation associated with Alzheimer's disease (TRANQUILITY II and III) NEW HAVEN, Conn., May 16, 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 positive top-line data from its Phase 1b multiple ascending dose (MAD) trial of BXCL501 (dexmedetomidine) sublingual film.

BioXcel Therapeutics Announces Positive Top-Line Data from Repeat Dosing of BXCL501 in Phase 1b Multiple Ascending Dose Trial in Healthy Volunteers for Major Depressive Disorder (MDD) Program

BioXcel Therapeutics, Inc. is currently in exciting times, awaiting very important clinical trial results in the coming weeks. The recently released BioXcel Therapeutics first-quarter results provided a low revenue figure for IGALMI, however, the market has not focused on that number.

BioXcel Therapeutics: It Is All About Key Upcoming Clinical Data Readouts

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A fair number of Nasdaq-listed growth stocks moved higher this week. CRISPR Therapeutics, BioXcel Therapeutics, and Verve Therapeutics were among the biggest winners this week.

Why These 3 Nasdaq Stocks Were Glowing Green This Week

BioXcel Therapeutics announced 2023 first-quarter earnings today. While revenue for the three-month period wasn't a needle-mover, investors appear to be intrigued by a series of upcoming trial readouts.

Why BioXcel Therapeutics Stock Marched Higher Today

BioXcel Therapeutics, Inc. (NASDAQ:BTAI ) Q1 2023 Earnings Conference Call May 8, 2023 8:00 AM ET Company Participants Vimal Mehta - Chief Executive Officer & Founder Rob Risinger - Chief Medical Officer, Neuroscience Matt Wiley - Chief Commercial Officer Richard Steinhart - Chief Financial Officer Conference Call Participants Robyn Karnauskas - Truist Securities Mary Kate - Bank of America Colin Bristow - UBS Yatin Suneja - Guggenheim Partners Sumant Kulkarni - Canaccord Genuity Ram Selvaraju - H.C. Wainwright Operator Good morning, and welcome to the BioXcel Therapeutics First Quarter 2023 Financial Results Conference Call.

BioXcel Therapeutics, Inc. (BTAI) Q1 2023 Earnings Call Transcript

IGALMI™ (dexmedetomidine) commercial momentum accelerating with doubling of formulary wins, unlocking more than $55 million in targeted market opportunity, and an additional $255 million scheduled to vote

BioXcel Therapeutics Reports First Quarter 2023 Financial Results and Recent Operational Highlights

BioXcel is banking on artificial intelligence to gain a second speedy FDA approval — and BTAI stock is soaring on the possibility. The post The Next Evolution In Drugs?

The Next Evolution In Drugs? It's Artificial Intelligence, Says This CEO

NEW HAVEN, Conn., May 02, 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 Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, will participate in a fireside chat at the BofA Securities 2023 Health Care Conference in Las Vegas on Tuesday, May 9, 2023 at 10:15 a.m. PT. He will be joined by Robert Risinger, M.D., Chief Medical Officer, Neuroscience, and Matt Wiley, Chief Commercial Officer.

BioXcel Therapeutics to Present at the BofA Securities 2023 Health Care Conference

We are reiterating the hold rating due to Igalmi launch uncertainties around market access and the limited commercial capacity of BTAI. Optimistic about upcoming Tranquility 2 and Serenity 3 trial readouts in 2Q23.

BioXcel Therapeutics: All Eyes On Igalmi's Ramp, Reiterating Hold Rating

NEW HAVEN, Conn., April 24, 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 release its first quarter 2023 financial results on Monday, May 8, 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 First Quarter 2023 Financial Results on May 8, 2023

BioXcel Therapeutics, Inc. has just released results for the fourth quarter of 2022. Some analysts have expressed doubts about the commercial success of its Igalmi launch.

BioXcel Therapeutics' Igalmi Commercial Launch: Not As Bad As Some May Think

NEW HAVEN, Conn., March 14, 2023 (GLOBE NEWSWIRE) -- OnkosXcel Therapeutics, LLC (“OnkosXcel”) today announced that it has confidentially submitted a draft registration statement on Form S-1 with the Securities and Exchange Commission (the “SEC”) relating to the proposed initial public offering of its common stock following its conversion into a corporation. The number of shares to be offered and the price range for the proposed offering have not yet been determined. The initial public offering is expected to take place after the SEC completes its review process, subject to market and other conditions. OnkosXcel is a subsidiary of BioXcel Therapeutics, Inc. (Nasdaq: BTAI).

OnkosXcel Therapeutics Announces Confidential Submission of Draft Registration Statement for Proposed Initial Public Offering

BioXcel Therapeutics, Inc. (NASDAQ:BTAI ) Q4 2022 Earnings Conference Call March 9, 2023 8:30 AM ET Company Participants Vimal Mehta - Chief Executive Officer & Founder Matt Wiley - Chief Commercial Officer Richard Steinhart - Chief Financial Officer Rob Risinger - Chief Medical Officer, Neuroscience Vincent O'Neill - Chief R&D Officer of OnkosXcel Therapeutics Conference Call Participants Colin Bristow - UBS Robyn Karnauskas - Truist Securities Greg Harrison - Bank of America Graig Suvannavejh - Mizuho Securities Sumant Kulkarni - Canaccord Genuity Eddie Hickman - Guggenheim Partners Corinne Jenkins - Goldman Sachs Ram Selvaraju - H.C. Wainwright Samir Devani - Rx Securities Operator Good morning, and welcome to the BioXcel Therapeutics Fourth Quarter and Full Year 2022 Financial Results Conference Call.

BioXcel Therapeutics, Inc. (BTAI) Q4 2022 Earnings Call Transcript

IGALMI™ (dexmedetomidine) commercial execution fully underway in 2023 with key focus on market access and demand generation through expanded field team

BioXcel Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Operational Highlights

NEW HAVEN, Conn., Feb. 23, 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 release its fourth quarter and full year 2022 financial results on Thursday, March 9, 2023 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 2022 Financial Results on March 9, 2023

NEW HAVEN, Conn., Feb. 21, 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 Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, additional members of the management team, and other BioXcel team members will ring the closing bell of the Nasdaq Stock Market today, Tuesday, February 21, 2023.

BioXcel Therapeutics to Ring Nasdaq Stock Market Closing Bell Today

BioXcel has just published top-line data from the Phase IIa trial of BXCL701 for mSCNC with very promising results. These results position BXCL701 as a valuable asset for the first time.

BioXcel BXCL701: Another Step Forward In The Race For An mCRPC Treatment

BXCL701 plus KEYTRUDA® (pembrolizumab) demonstrated composite response rate of 25% in patients with metastatic SCNC-variant castration-resistant prostate cancer

BioXcel Therapeutics Announces Positive Full Data from Phase 2 Trial of BXCL701 in Rare, Aggressive Form of Prostate Cancer; to be Presented at 2023 ASCO Genitourinary Cancers Symposium

NEW HAVEN, Conn., Feb. 08, 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 Key Opinion Leader (KOL) Day focused on its lead immuno-oncology program BXCL701 for the investment community on Tuesday, February 21, 2023 from 1:00 to 3:00 p.m. ET.

BioXcel Therapeutics to Host BXCL701 Key Opinion Leader Day to Highlight Company's Investigational, Oral Innate Immune Activator for Rare Form of Prostate Cancer

Results demonstrate encouraging response rate of BXCL701 plus KEYTRUDA® (pembrolizumab) in patients with SCNC

BioXcel Therapeutics Announces Promising Top-Line Results from Phase 2 Trial of BXCL701 in Aggressive Form of Rare Prostate Cancer

NEW HAVEN, Conn., Dec. 22, 2022 (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 Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, will present corporate updates and anticipated milestones for 2023 at the 41st Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 11, 2023 at 9:45 a.m. PST.

BioXcel Therapeutics to Present at 41st Annual J.P. Morgan Healthcare Conference

Pivotal trial will evaluate efficacy and safety of BXCL501 in Alzheimer's patients in nursing homes with moderate to severe dementia

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

News for BioXcel Therapeutics Stock (BTAI)