Forward-looking statements in this press release include but are not limited to the enrollment of patients in the Phase 3 SERENITY trials and the timing of topline data from these trials. Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere … BXCL701 is one of the most advanced cancer treatments in development that is designed to enhance innate immunity, a potentially powerful treatment approach against cancer when used as a monotherapy or in combination.”. BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. Eligible subjects (acutely agitated subjects with bipolar disorder, generally hypomanic, manic or mixed episodes) may be identified in outpatient clinics, mental … Therefore, BXCL701 may render “cold” tumors “hot,” making them more detectable by the adaptive immune system and thereby facilitating the development of a strong anti-cancer immune response. Vice President and Head of Clinical Operations and Project Management at BioXcel Therapeutics Inc. New York City Metropolitan Area 500+ connections. Fully illustrated and written in Dr. Seuss-style verse 'Oh, the Places You'll Go Oh Oh!' is about overcoming shame, realizing the life-changing power of pleasure, and discovering oneself from Sexual Debut (because "virginity" needs a ... It marks the beginning of our plans for the global development of our lead programs.”, Dr. Vimal Mehta, Chief Executive Officer of BTI added, “We remain committed to translating the potential of BXCL701’s novel mechanism of action into therapies that can fundamentally change the lives of cancer patients. The filing of this CTA is the first milestone in the expansion of our footprint into major markets outside the US.  We believe that our pancreatic cancer clinical development partnership with Nektar, Pfizer and Merck KGaA, Darmstadt, Germany will also benefit the broader BXCL701 program.”. BioXcel believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. BTI may not realize its expectations, and its beliefs may not prove correct. Professor de Bono is a clinical investigator in the KEYNOTE- 199 trial, a study evaluating Pembrolizumab in docetaxel pre-treated castrate-resistant metastatic prostate cancer patients. Pipeline Prospector delivers free access to a database of drugs under clinical trials which made headlines done by BioXcel Therapeutics. BioXcel Therapeutics (NASDAQ:BTAI)is starting the week on a strong note. Second, a Wall Street analyst reiterated his buy rating and increased his price target on the company's stock. Title: Phase 1b/2 study of BXCL701, an oral activator of the systemic innate immunity pathway, combined with pembrolizumab (pembro), in men with metastatic castration-resistant prostate cancer (mCRPC) Category: In-Progress Clinical TrialsLive Q&A: Wednesday, Nov. 11 from 5:15-5:45 p.m. Eastern Time and Friday, Nov. 13 from 4:40-5:10 p.m. Eastern TimePoster Number: 341, Title: Targeting Innate Immunity with BXCL701 in Combination with Pembrolizumab in Patients with Advanced Solid Cancers: Phase 2 Basket StudyCategory: In-Progress Clinical TrialsLive Q&A: Thursday, Nov. 12 from 4:50-5:20 p.m. Eastern Time and Saturday, Nov. 14, from 1:00-1:30 p.m. Eastern TimePoster Number: 782. Consequently, forward-looking statements should be regarded solely as BioXcel's current plans, estimates and beliefs. Designed to stimulate both the innate and acquired immune systems, BXCL701 works by inhibiting dipeptidyl peptidase (DPP) 8/9 and blocking immune evasion by targeting Fibroblast Activation Protein (FAP). BioXcel Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on drug development that utilizes novel artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology. Our neuroscience and immuno-oncology programs utilize our approach to drug development. BXCL501 is an investigational sublingual thin film formulation of dexmedetomidine in development for acute treatment of agitation in multiple neuropsychiatric indications. About BioXcelBioXcel Corporation is a next generation biotechnology company dedicated to improving the probability of the clinical and commercial success of drugs by applying big data analytics. Forward-Looking StatementsThis press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. A non-invasive therapy that causes rapid symptom relief and de-escalates agitation may be necessary to avoid the costly and traumatic use of coercive techniques, like physical restraint and seclusion, which require admission and prolonged hospitalization. BioXcel Therapeutics Announces Primary and Secondary Endpoints Met in Two Pivotal Phase 3 Trials of BXCL501 for the Acute Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorder. BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. Expands global footprint for lead immuno-oncology program, BXCL701, Patient recruitment in US tNEPC study on-track; additional sites being activated, Immuno-oncology Clinical Advisory Board expanded with addition of prominent U.K. medical oncologist, Professor Johann de Bono, M.D., Ph.D., who will serve as European Principal Investigator for trial, IND filing for BXCL701 in combination with NKTR-214 and avelumab (triple combination) in pancreatic cancer expected in 2Q 2019 following positive FDA feedback. A key secondary endpoint includes determining the earliest time where an effect on agitation is apparent as measured by the change from baseline in PEC total score. This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in schizophrenia. In this fun, illuminating book, cannabis journalist Amanda Siebert delves deep into the latest research to separate marijuana fact from fiction, revealing ten evidence-based ways this potent little plant can improve your life. BTI's two most advanced clinical development programs are BXCL501, an investigational sublingual thin film formulation in development for acute treatment of agitation resulting from neuropsychiatric disorders, and BXCL701, an investigational orally administered systemic innate immunity activator in development for treatment of a rare form of prostate cancer and for treatment of pancreatic cancer in combination with other immuno-oncology agents. About BXCL701BXCL701 is an orally-available systemic innate-immune activator with dual mechanisms of action. BTI believes that BXCL501 directly targets a causal agitation mechanism, and the Company has observed anti-agitation effects in multiple clinical studies across multiple neuropsychiatric indications. BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. First, BioXcel reported positive results from two clinical trials for one of its lead pipeline candidates. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; its limited experience in drug discovery and drug development; its dependence on the success and commercialization of BXCL501 and BXCL701 and other product candidates; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; its approach to the discovery and development of product candidates based on EvolverAI is novel and unproven; its exposure to patent infringement lawsuits; its ability to comply with the extensive regulations applicable to it; its ability to commercialize its product candidates; and the other important factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Any such forward-looking statements represent management’s estimates as of the date of this press release. This volume focuses on a globally important group of intracellular prokaryotic pathogens which affect livestock animals. Found inside – Page 66BioXcel Therapeutics (AI in Biopharmaceutical Development) It utilizes AI to predict and discover different medicines in the field of Neuroscience and Immuno-Oncology. In fact, the drug renovation study at the organization implements AI ... BioXcel cannot guarantee future results, events, levels of activity, performance or achievements. BioXcel Therapeutics ( BTAI) intends to sell shares of its common stock for gross proceeds of $69 million from a U.S. IPO, according to an S-1 registration statement. The posters will also be available in the “News & Media” section of the Company’s website at www.bioxceltherapeutics.com. A Trial of BXCL701 and Pembrolizumab in Patients With mCRPC. Found insideThe Advances in Pharmacology series presents a variety of chapters from the best authors in the field. Found insideThis volume brings together the latest basic and clinical research examining the effects and underlying mechanisms of psychedelic drugs. Examples of drugs within this group include LSD, psilocybin, and mescaline. Additionally, BioXcel Therapeutics is preparing to file an Investigational New Drug (IND) application with the FDA for a clinical trial evaluating the triple combination of BXCL701, NKTR-214 and avelumab in the treatment of advanced pancreatic cancer. Stress Resilience: Molecular and Behavioral Aspects presents the first reference available on the full-breadth of cutting-edge research being carried out in this field. About BioXcel Therapeutics, Inc.:BioXcel Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on drug development that utilizes novel artificial intelligence to identify the next wave of medicines across neuroscience and immuno-oncology. This volume collects the invited lectures and some selected contributions presented at the 5th International Meeting on Clinical Pharmacology in Psychiatry, which was held 26-30 June 1988 at the University of Troms0, Norway. In early 2021, we announced positive topline results from the TRANQUILITY Phase 1b/2 trial for the acute treatment of agitation associated with dementia, including Alzheimer’s disease. About Agitation in NeuropsychologyAgitation is a common and difficult to manage symptom associated with a number of psychiatric conditions, including schizophrenia and bipolar disorder. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The book is the result of a unique collaboration between the Vatican's Pontifical Council for Culture and the Stem for Life Foundation. Dr. Chetan D. Lathia, SVP & Head of Translational Medicine, Clinical Pharmacology and Regulatory Affairs of BTI said, “The filing of the CTA in the U.K., for the BXCL701 combination trial is an important regulatory milestone for BTI. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption “Risk Factors” in BioXcel's Form 10K for the period ending December 31, 2018, and BioXcel's other filings made with the Securities and Exchange Commission. While BTI may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. Found insideThe American Psychiatric Association Practice Guideline on the Use of Antipsychotics to Treat Agitation or Psychosis in Patients With Dementia seeks to fulfill this need to improve the care of patients with dementia who are exhibiting ... Found inside – Page 7DRUG DEVELOPMENT FOR NERVOUS SYSTEM DISORDERS 7 gets, but also to know when to intervene and how to move the biology ... Frank Yocca, senior vice president of CNS research and development at BioXcel Corporation, said these problems are ... BXCL501 is being evaluated in the SERENITY program, consisting of two Phase 3 studies for the acute treatment of agitation in patients with schizophrenia (SERENITY I) and bipolar disorder (SERENITY II). The book features numerous problem sets and examples, clear illustrations, and extensive appendices that provide additional information on mathematics, physics and chemistry topics that support the text. BTI's two most advanced clinical development programs are BXCL501, a sublingual thin film formulation designed for acute treatment of agitation resulting from neurological and psychiatric disorders, and BXCL701, an immuno-oncology agent designed for treatment of a rare form of prostate cancer and for treatment of pancreatic cancer. “Up to now, all schizophrenia and bipolar patients enrolled have successfully self-administered the BXCL501 treatment, guided by a healthcare provider, and the trials seem to be progressing well. Eleven-year-old Tilly saved lives in Thailand by warning people that a tsunami was coming. “With three Partial Responses over the course of the two programs, and a manageable side effect profile, we continue to be encouraged by BXCL701’s potential for treating several difficult-to-treat cancers. BioXcel’s two most advanced clinical development programs are BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine designed for the treatment of agitation and opioid withdrawal symptoms. The SERENITY studies are randomized, double-blinded, placebo-controlled, adaptive trials of up to 750 patients, 18 to 75 years of age. “We, along with our collaborator MD Anderson, are pleased to be presenting safety and initial efficacy data from the Phase 1b/2 trial in advanced prostate cancer and the MD Anderson-led basket trial, both of which are combination trials with BXCL701 and KEYTRUDA,” commented Vincent J. O’Neill, M.D., Senior Vice President and Chief Medical Officer of BTI. Found insideBioXcel Therapeutics' work in AIbased medication improvement was named as one of the “Most Innovative Healthcare AI Developments of 2019.” AI Functioning in Clinical Trials: Atomwise utilizes AI to handle a portion of the present most ... BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. BioXcel may not realize its expectations, and its beliefs may not prove correct. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. Additionally, he leads the Prostate Cancer Targeted Therapy Group and the Cancer Biomarkers laboratory team. Recent consensus guidelines emphasize the need for non-coercive management strategies to protect the therapeutic alliance between patients and their healthcare providers—an alliance that is critical for the effective management of chronic psychiatric conditions. Highly statistically significant improvements in PEC score observed vs. placebo (p<0.0001) at two hours in the SERENITY trials for both doses tested. NEW HAVEN, Conn., March 19, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced that more than one-third of the patients in the Phase 3 SERENITY trials have been enrolled and treated. The primary endpoint of the trials is reducing acute agitation measured by the Positive and Negative Syndrome Scale, examining the Excited Component (“PEC”) change from baseline compared to placebo. Avoiding the wild excesses taken by both sides on this issue, this book is unique for the light it sheds on the possibilities and the limitations of psychedelic drugs, as well as on the techniques for working with them. Data from the open-label trial will support the ongoing global clinical development of BXCL701. This candidate is currently being developed as therapy for advanced prostate cancer and pancreatic cancer (both “cold” tumors) and other advanced solid cancers that are treatment naïve or resistant to checkpoint inhibitors (“hot” tumors). BioXcel Therapeutics' strategy involves studying drug candidates who have at least demonstrated clinical efficacy in Phase 2 trials. Approved and experimental immunotherapies often struggle to address cancers that appear “cold” or uninflamed. BioXcel Therapeutics, Inc. is hiring a Executive Director, Head of Pharmacovigilance & Drug Safety, with an estimated salary of $150,000 - $200,000. The book reveals strategies for standing apart from the competition, what hiring managers look for when considering candidates, and what gets the right candidates hired. Following discussions with the FDA in Q2 2021, we plan on advancing BXCL501 into a late-stage clinical development program for the acute treatment of agitation … BXCL501 is also being evaluated in a Phase 1b/2 trial (TRANQUILITY) for the treatment of agitation associated with dementia, and the Company is preparing to initiate a Phase 1b/2 study (RELEASE) of BXCL501 for the treatment of opioid withdrawal symptoms. However, most of the functions of the glycosyltransferase genes and related genes are unknown. This fact has stimulated numerous new and interesting approaches in molecular biologi cal investigations. NEW HAVEN, Conn., May 14, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced full enrollment of its pivotal Phase 3 SERENITY trials evaluating BXCL501 for the acute treatment of agitation in patients with schizophrenia and … Since the beginning of the pandemic, the market's primary emphasis has been on the development of an effective vaccine. This important new text is an invaluable resource for the practicing physician who must be aware of the broad and troubling manifestations of interstitial lung disease. Contact Information:BioXcel TherapeuticsThe Ruth GroupLee Roth/ Janhavi Mohite646-536-7012/ 7026         lroth@theruthgroup.com/ jmohite@theruthgroup.com  Â. NEW HAVEN, Conn., March 19, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. 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