BioXcel Therapeutics(BTAI)

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BioXcel Therapeutics(BTAI) - 2024 Q2 - Quarterly Report
2024-08-06 13:05
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38410 BioXcel Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 82-1386754 (S ...
BioXcel Therapeutics(BTAI) - 2024 Q2 - Quarterly Results
2024-08-06 11:05
Exhibit 99.1 BioXcel Therapeutics Reports Second Quarter 2024 Financial Results Planning initiation of SERENITY At-Home pivotal Phase 3 trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia Advancing plans for TRANQUILITY In-Care pivotal Phase 3 trial with BXCL501 for agitation associated with Alzheimer's dementia Reported positive topline results from IGALMI™ post-marketing requirement (PMR) study Conference call set for 8:00 a.m. ET today NEW HAVEN, Conn., Au ...
BioXcel Therapeutics Announces Preliminary Estimated Unaudited Second Quarter Net Revenues from Sales of IGALMI™ (dexmedetomidine) Sublingual Film
Newsfilter· 2024-07-16 11:00
Focused market-access strategy generates estimated net revenue of approximately $1.1 million, highest quarterly net revenue since commercial launch Represents 90% increase from the prior quarter and 141% increase from the second quarter of 2023 NEW HAVEN, Conn., July 16, 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 preliminary estimated ...
BioXcel Therapeutics Announces Preliminary Estimated Unaudited Second Quarter Net Revenues from Sales of IGALMI™ (dexmedetomidine) Sublingual Film
GlobeNewswire News Room· 2024-07-16 11:00
Represents 90% increase from the prior quarter and 141% increase from the second quarter of 2023 "We are pleased with the positive feedback we continue to receive from physicians, caregivers, and patients about IGALMI™ for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "Since our commercial launch and deployment of focused market-access strategy, we are continuing to build IGALMI brand equity. Our current ind ...
BioXcel Therapeutics Announces Positive Topline Results from Post-Marketing Requirement Study Evaluating PRN Treatment of IGALMI™ (dexmedetomidine) Sublingual Film for Agitation Associated with Bipolar Disorders or Schizophrenia
Newsfilter· 2024-06-25 11:00
Results supportive of Phase 3 SERENITY and TRANQUILITY programs INDICATION Contact Information Mean PEC score reduction was observed following all doses of IGALMI administered as needed over the treatment period (see graph below). All patients showed improvement in agitation symptoms as assessed by the CGI-I Scale for all doses administered as needed over the treatment period. Prior to treatment with IGALMI, most patients exhibited mild to moderate agitation as assessed by the Agitation Calmness Evaluation ...
BioXcel Therapeutics Announces Oral and Poster Presentations at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting
Newsfilter· 2024-05-21 11:00
Core Viewpoint - BioXcel Therapeutics, Inc. is leveraging artificial intelligence to develop innovative medicines in neuroscience and immuno-oncology, with upcoming presentations at the 2024 ASCP Annual Meeting highlighting their research efforts [1][10]. Presentation Details - Oral Presentation: "An Exploratory Comparison of Sublingual Dexmedetomidine with Quetiapine in Healthy Elderly Subjects" scheduled for May 28, 2024, from 2:20-2:30 p.m. ET at Salon 3 [2]. - Poster Presentation: "Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of BXCL501 with Concomitant Treatment with Anti-Depressant in Healthy Volunteers" on May 29, 2024, from 11:15 a.m.-1:00 p.m. ET at Salon 4 [2]. - Poster Presentation: "A Phase Ib/II Multicenter, Randomized, Double Blind, Placebo-Controlled, Ascending Dose Finding Study of BXCL501 in Agitation Associated with Dementia" on May 30, 2024, from 12:30-2:15 p.m. ET at Salon 4 [2]. Product Information - BXCL501 is an investigational sublingual film formulation of dexmedetomidine, targeting agitation in neuropsychiatric disorders, currently under investigation for various conditions including agitation associated with dementia and bipolar disorders [3]. - BXCL501 has received Breakthrough Therapy designation from the FDA for treating agitation associated with dementia and Fast Track designation for agitation related to schizophrenia and bipolar disorders [3]. Company Overview - BioXcel Therapeutics, Inc. focuses on drug re-innovation by utilizing existing approved drugs and machine learning algorithms to identify new therapeutic indications [10].
BioXcel Therapeutics(BTAI) - 2024 Q1 - Earnings Call Transcript
2024-05-09 13:53
BioXcel Therapeutics, Inc. (NASDAQ:BTAI) Q1 2024 Results Earnings Conference Call May 9, 2024 8:00 AM ET Company Participants Vimal Mehta - Chief Executive Officer and Founder Vincent O'Neill - Executive Vice President and Chief of Product Development and Medical Officer Richard Steinhart - Senior Vice President and Chief Financial Officer Matt Wiley - Senior Vice President and Chief Commercial Officer Robert Risinger - Chief Medical Officer, Neuroscience Conference Call Participants Colin Bristow - UBS Ram ...
BioXcel Therapeutics(BTAI) - 2024 Q1 - Quarterly Report
2024-05-09 13:05
Table of Contents (Mark One) BioXcel Therapeutics, Inc. (Exact name of registrant as specified in its charter) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ⌧ No ◻ Indicate by check mark whether the registrant ...
BioXcel Therapeutics(BTAI) - 2024 Q1 - Quarterly Results
2024-05-09 11:12
Exhibit 99.1 BioXcel Therapeutics Reports First Quarter 2024 Financial Results Advancing TRANQUILITY and SERENITY program plans for two pivotal Phase 3 trials to expand BXCL501 market potential in acute treatment of agitation Strengthened intellectual property portfolio for BXCL501 with grant of two new patents, in Japan and the U.S. Completed $25 million registered direct of ering Conference call set for 8:00 a.m. ET today NEW HAVEN, Conn., May 9, 2024 — BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biophar ...
BioXcel Therapeutics Announces Late-Breaking Abstract on Preliminary Findings from Phase 2 Investigator-Sponsored Trial of BXCL701 and KEYTRUDA® in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Selected for Presentation at 2024 ASCO Annual Meeting
Newsfilter· 2024-04-24 14:30
Poster presentation scheduled for June 1, 2024, 1:30-4:30 PM CT /2:30-5:30 PM ET Trial being led by Georgetown University's Lombardi Comprehensive Cancer Center NEW HAVEN, Conn., April 24, 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 a late-breaking abstract with preliminary findings from the Phase 2 investigator-sponsored trial of ...