BioXcel Therapeutics Azioni (NASDAQ: BTAI)

Ultime notizie per BioXcel Therapeutics (NASDAQ:BTAI) Azioni

BioXcel Therapeutics

BioXcel Therapeutics Inc is a clinical-stage biopharmaceutical company. The company is focused on drug development utilizing novel artificial intelligence (AI) to identify the next wave of medicines across neuroscience and immuno-oncology. The pipeline products of the company are BXCL501 and BXCL701. The company's commercial product, IGALMI (developed as BXCL501) is a proprietary, sublingual film formulation of dexmedetomidine approved by the FDA for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

BioXcel Therapeutics, Inc. - Common Stock

BioXcel Therapeutics Inc

News

BTAI

BioXcel Therapeutics Reports Department Of Defense Grant To University Of North Carolina To Fund Study Of BXCL501; Phase 2a Efficacy And Safety Trial Enrollment Initiation Expected In H1 2025

Biotech

Health Care

General

Bioxcel Therapeutics Will Reduce Its Workforce By 15 Employees, Or Approximately 28% Of The Company's Headcount-Filing

Bioxcel Therapeutics Announced Its Clinical Prioritization, While Deprioritizing Sales Efforts For Its Approved Drug Igalmi (Dexmedetomidine) Sublingual Film. The Company Plans To Maintain Igalmi In The Market Without Its Current Commercial Infrastructure

HC Wainwright &amp; Co. analyst Raghuram Selvaraju reiterates BioXcel Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BTAI#NASDAQ">BTAI</a>) with a Buy and maintains $7 price target.

Price Target

Reiteration

Analyst Ratings

HC Wainwright & Co. Reiterates Buy on BioXcel Therapeutics, Maintains $7 Price Target

BioXcel Therapeutics Initiated Patient Enrollment In SERENITY At-home Pivotal Phase 3 Trial Of BXCL501 In At-home Setting For Acute Treatment Of Agitation Associated With Bipolar Disorders Or Schizophrenia. The Trial Duration Currently Is Expected To Be 9 To 12 Months

Canaccord Genuity analyst Sumant Kulkarni maintains BioXcel Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BTAI#NASDAQ">BTAI</a>) with a Buy and maintains $7 price target.

Canaccord Genuity Maintains Buy on BioXcel Therapeutics, Maintains $7 Price Target

UBS analyst Colin Bristow maintains BioXcel Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BTAI#NASDAQ">BTAI</a>) with a Neutral and lowers the price target from $3.5 to $1.

UBS Maintains Neutral on BioXcel Therapeutics, Lowers Price Target to $1

HC Wainwright &amp; Co. analyst Raghuram Selvaraju maintains BioXcel Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BTAI#NASDAQ">BTAI</a>) with a Buy and lowers the price target from $10 to $7.

HC Wainwright & Co. Maintains Buy on BioXcel Therapeutics, Lowers Price Target to $7

WIIM

BioXcel Therapeutics shares are trading higher after the company reported better-than-expected Q2 financial results.

Earnings

BioXcel Therapeutics Q2 2024 GAAP EPS $(0.21) Beats $(0.77) Estimate, Sales $1.104M Beat $759.200K Estimate

BioXcel Therapeutics Announced Preliminary Sales Of Igalmi (Dexmedetomidine) Sublingual Film For Q2 Of Approximately $1.1M, Up Approximately 90% Quarter Over Quarter And Approximately 141% Year-over-year

Tuesday, BioXcel Therapeutics Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BTAI#NASDAQ">BTAI</a>) released topline results from a post-marketing requirement (PMR) study of Igalmi (dexmedetomidine) sublingual film that demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with the 180 mcg dose after seven days of <a target="_blank" href="https://www.benzinga.com/pressreleases/24/06/g39474259/bioxcel-therapeutics-announces-positive-topline-results-from-post-marketing-requirement-study-eval" rel="noreferrer noopener">PRN (as-needed) treatment</a>.
In the single-arm, open-label study, 28 inpatient adults with frequent episodes of agitation associated with bipolar disorders or schizophrenia self-administered 180 mcg dose of Igalmi as needed over seven days. A total of 83 episodes were treated.
Although the study was not statistically powered to evaluate repeat-dose efficacy, changes in agitation were assessed through the Positive and Negative Syndrome Scale-Excitatory Component (PEC or PANSS-EC) Score and the&nbsp;Clinical Global Impressions – Improvement (CGI-I) Scale, the same measures as used in previous Phase 3 studies.
Mean PEC score reduction was observed following all doses of Igalmi administered as needed over the treatment period.
All patients showed improvement in agitation symptoms for all doses administered as needed over the treatment period.
Before treatment with Igalmi, most patients exhibited mild to moderate agitation as assessed by the Agitation Calmness Evaluation Scale (ACES).
ACES scores post-dose revealed a marked calming effect, with no patient experiencing unarousable somnolence.
In addition, no withdrawal or rebound phenomena were observed.
The 180 mcg dose of Igalmi was generally well tolerated and showed favorable safety results in treating patients with frequent episodes of agitation.
There were no discontinuations due to adverse events. No serious adverse events were reported.
&#8220;We are pleased these study findings showed consistent responses to PRN treatment for episodes of agitation over the study duration with no evidence of worsening or withdrawal,&#8221; said Rob Risinger, Chief Medical Officer of Neuroscience.
Price Action: BTAI shares are up 2.10% at $1.215 at last check Tuesday.
Photo via Shutterstock

Equities

BioXcel Therapeutics' Approved Drug For Bipolar Disorders/Schizophrenia Shows No Evidence Of Worsening Or Withdrawal In Post-Marketing Study

&quot;We are pleased these study findings showed consistent responses to PRN treatment for episodes of agitation over the study duration with no evidence of worsening or withdrawal,&quot; said Rob Risinger, M.D., Chief Medical Officer of Neuroscience. &quot;We look forward to sharing these IGALMI PMR data with FDA.&quot;

BioXcel Therapeutics Reports Topline Results From A Post-Marketing Requirement Study Of IGALMI; Says Study Achieved Its Objective

HC Wainwright &amp; Co. analyst Raghuram Selvaraju reiterates BioXcel Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BTAI#NASDAQ">BTAI</a>) with a Buy and maintains $10 price target.

HC Wainwright & Co. Reiterates Buy on BioXcel Therapeutics, Maintains $10 Price Target

BioXcel Therapeutics shares are trading higher after the company reported better-than-expected Q1 financial results.

BioXcel Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BTAI#NASDAQ">BTAI</a>) reported quarterly losses of $(0.87) per share which beat the analyst consensus estimate of $(1.04) by 16.35 percent. This is a 52.72 percent increase over losses of $(1.84) per share from the same period last year. The company reported quarterly sales of $582.000 thousand which beat the analyst consensus estimate of $464.000 thousand by 25.43 percent. This is a 182.52 percent increase over sales of $206.000 thousand the same period last year.

Earnings Beats

BioXcel Therapeutics Q1 2024 GAAP EPS $(0.87) Beats $(1.04) Estimate, Sales $582.000K Beat $464.000K Estimate

Poster presentation scheduled for June 1, 2024, 1:30-4:30 PM CT /2:30-5:30 PM ET &nbsp;
Trial being led by Georgetown University's Lombardi Comprehensive Cancer Center
NEW HAVEN, Conn., April 24, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BTAI#NASDAQ">BTAI</a>), 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 BXCL701 in combination with KEYTRUDA&#xAE;&nbsp;(pembrolizumab)&nbsp;in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) has been selected for presentation in a poster session at the 2024 American Society of Clinical Oncology&nbsp;(ASCO) Annual Meeting. The meeting will take place from May 31 to June 4, 2024 in Chicago, IL.
The trial, which is led by investigators at Georgetown University's Lombardi Comprehensive Cancer Center, is evaluating BXCL701, an investigational, oral innate immune activator designed to inflame the tumor microenvironment and thereby augment the activity of checkpoint inhibitors. On February 6, 2024, BioXcel Therapeutics announced the <a href="https://www.globenewswire.com/Tracker?data=rYXzl3Ysh1NoBS16lTFm2Q0RasqU-7-vsDob-XK87jPHzmyK4rWqym-wGjfQwTX2mrS4SLD-xWFqgEZZs4BMQtOf7o7OP4QvFmif2E-pyEO_cGBhAVJqIjTDGLAKoL4fIuQdHemEDXC6DlAafIqO4p39rzHo1KterW9DLoxFTYh1g6Kiv0f5fGdej3pwOjR9_E18Z2_Nos161_htNhDe8ph9BA3E6o_Ez5WU7wV4WeAWwUWSn4qIRGYP59DAY5WG">completion of patient enrollment</a> in the safety lead-in portion&nbsp;of the trial. Through its OnkosXcel Therapeutics immuno-oncology subsidiary, BioXcel Therapeutics is collaborating with Dr. Louis M. Weiner, director of the Lombardi Comprehensive Cancer Center, and Dr. Benjamin Weinberg, principal investigator of the study. BioXcel Therapeutics and Merck &amp; Co. are providing BXCL701 and KEYTRUDA for the trial, respectively.
Poster Presentation&#x2A;
Title:&nbsp;Phase 2 Trial of BXCL701 and Pembrolizumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma (EXPEL-PANC): Preliminary Findings
Presenter:&nbsp;Dr. Benjamin Weinberg, Ruesch Center for the Cure of Gastrointestinal Cancers, Lombardi Comprehensive Cancer Center
Abstract:&nbsp;LBA4132
Poster: 112
Session:&nbsp;Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Date: June 1, 2024
Time: 1:30-4:30 PM CT /2:30-5:30 PM ET
&#x2A;The poster abstract will be released at 7:00 AM CT /8:00 AM ET on the day of the presentation.
About BXCL701 BXCL701 is an investigational, oral innate immune activator designed to initiate inflammation in the tumor microenvironment. Approved and experimental immunotherapies often fail to address cancers that appear "cold." Therefore, BXCL701 is being evaluated to determine if it can render "cold" tumors "hot," making them more detectable by the adaptive immune system and thereby facilitating the development of a strong anticancer immune response. OnkosXcel Therapeutics' preclinical data support BXCL701's potential synergy with both current checkpoint inhibitors and emerging immunotherapies directed to activate T-cells. BXCL701 is currently being developed as a potential therapy for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. BXCL701 has received Orphan Drug Designation from the U.S. Food and Drug Administration in four indications: acute myelogenous leukemia, pancreatic cancer, stage IIb to IV melanoma, and soft tissue sarcoma. The U.S. Food and Drug Administration (FDA) designated as a Fast Track development program the investigation of BXCL701 in combination with a checkpoint inhibitor for treatment of patients with metastatic small cell neuroendocrine prostate cancer (SCNC) with progression on chemotherapy and no evidence of microsatellite instability. An 800+-subject clinical database, with data collected by the Company and others, supports the ongoing development of BXCL701.

BioXcel Therapeutics Announces Late-Breaking Abstract On Preliminary Findings From Phase 2 Investigator-Sponsored Trial Of BXCL701 And KEYTRUDA In Metastatic Pancreatic Ductal Adenocarcinoma Selected For Presentation At 2024 ASCO Annual Meeting

Company plans to initiate SERENITY At-Home pivotal Phase 3 safety trial with 120 mcg dose following recent meeting with FDA
No FDA-approved therapies for acute treatment of agitation associated with bipolar disorders or schizophrenia in the home setting

BioXcel Therapeutics Reveals Plan For Evaluating BXCL501 In The At-Home Setting To Expand Its Market Potential

BioXcel Therapeutics GAAP EPS of -$0.21 beats by $0.57, revenue of $1.1M in-line

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BioXcel Therapeutics (NASDAQ:<a href="https://investorplace.com/stock-quotes/btai-stock-quote/">BTAI</a>) just reported results for the second quarter of 2024.<ul><li>BioXcel Therapeutics reported earnings per share of -21 cents. This was above the analyst estimate for EPS of -71 cents.</li><li>The company reported revenue of $1.10 million.</li><li>This was 62.35% better than the analyst estimate for revenue of $680,000.</li></ul><div>InvestorPlace Earnings is a project that leverages data from <a href="https://www.tradesmith.com">TradeSmith</a> to automate coverage of quarterly earnings reports. InvestorPlace Earnings distills key takeaways including earnings per share and revenue, as well as how a company stacks up to analyst estimates. These articles are published without human intervention, allowing us to inform our readers of the latest figures as quickly as possible. To report any concerns or inaccuracies, please contact us at <a href="mailto:editor@investorplace.com">editor@investorplace.com</a>.</div><h3>More From InvestorPlace</h3>
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									</ul>The post <a href="https://investorplace.com/earning-results/2024/08/btai-stock-earnings-bioxcel-therapeutics-for-q2-of-2024/">BTAI Stock Earnings: BioXcel Therapeutics Beats EPS, Beats Revenue for Q2 2024</a> appeared first on <a href="https://investorplace.com">InvestorPlace</a>.

BTAI Stock Earnings: BioXcel Therapeutics Beats EPS, Beats Revenue for Q2 2024

BioXcel Therapeutics, Inc. (BTAI) Q2 2024 Earnings Call Transcript

In a report released on August 9, Graig Suvannavejh from Mizuho Securities maintained a Hold rating on Bioxcel Therapeutics (BTAI – Research Report...

Bioxcel Therapeutics (BTAI) Receives a Hold from Mizuho Securities

Ram Selvaraju, an analyst from H.C. Wainwright, reiterated the Buy rating on Bioxcel Therapeutics (BTAI – Research Report). The associated price ta...

Bioxcel Therapeutics Earns Buy Rating on Promising Clinical Trials and Market Potential

Bioxcel Therapeutics ( ($BTAI) ) has provided an announcement. BioXcel Therapeutics, Inc. is set to reduce its workforce by 15 employees, a 28% cut...

Bioxcel Therapeutics Announces Restructuring and Leadership Changes

BioXcel ends commercial support for Igalmi as focus turns to neuro candidate

Companies in the Healthcare sector have received a lot of coverage today as analysts weigh in on Bioxcel Therapeutics (BTAI – Research Report) and ...

Analysts Offer Insights on Healthcare Companies: Bioxcel Therapeutics (BTAI) and Arcutis Biotherapeutics (ARQT)

Bioxcel Therapeutics ( ($BTAI) ) has provided an update. Matthew Wiley, Senior Vice President and Chief Commercial Officer of BioXcel Therapeutics,...

Bioxcel Therapeutics Senior VP Wiley Transitions to Consultant

BioXcel announces defense grant to UNC to fund study for treating acute stress disorder

ARQT

Press Releases

BioXcel Therapeutics Announces Oral and Poster Presentations at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting

BioXcel Therapeutics to Present at Jefferies Global Healthcare Conference

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

BioXcel Therapeutics Announces Preliminary Estimated Unaudited Second Quarter Net Revenues from Sales of IGALMI™ (dexmedetomidine) Sublingual Film

BioXcel Therapeutics to Report Second Quarter 2024 Financial Results on August 6, 2024

BioXcel Therapeutics Reports Second Quarter 2024 Financial Results

BioXcel Therapeutics to Participate in Canaccord Genuity 44th Annual Growth Conference

BioXcel Therapeutics Announces Initiation of SERENITY At-Home Pivotal Phase 3 Safety Trial of BXCL501 for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

BioXcel Therapeutics Announces Clinical Prioritization and Update on BXCL501 Late-Stage Programs for Agitation

Financing

BioXcel Therapeutics Announces U.S. Department of Defense Grant to University of North Carolina to Fund Study of BXCL501 (Sublingual Dexmedetomidine) for Treating Acute Stress Disorder

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