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BioXcel Therapeutics (NASDAQ:BTAI) Bolsa, Informe de interés en corto

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

WIIM

BTAI

BioXcel Therapeutics shares are trading lower after the company reported worse-than-expected Q3 revenue results.

BioXcel Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BTAI#NASDAQ">BTAI</a>) reported quarterly losses of $(0.32) per share which beat the analyst consensus estimate of $(0.60) by 46.67 percent. This is a 81.4 percent increase over losses of $(1.72) per share from the same period last year. The company reported quarterly sales of $214.00 thousand which missed the analyst consensus estimate of $1.31 million by 83.61 percent. This is a 37.24 percent decrease over sales of $341.00 thousand the same period last year.

Earnings

News

BioXcel Therapeutics Q3 2024 GAAP EPS $(0.32) Beats $(0.60) Estimate, Sales $214.00K Miss $1.31M Estimate

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Chemomab Therapeutics Ltd. - American Depositary Shares

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POST

Earnings Scheduled For November 14, 2024

BioXcel Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BTAI#NASDAQ">BTAI</a>) is set to give its latest quarterly earnings report on Thursday, 2024-11-14. Here's what investors need to know before the announcement.
Analysts estimate that BioXcel Therapeutics will report an earnings per share (EPS) of $-0.52. 
The market awaits BioXcel Therapeutics's announcement, with hopes high for news of surpassing estimates and providing upbeat guidance for the next quarter.
It's important for new investors to understand that guidance can be a significant driver of stock prices.
<h3>Overview of Past Earnings</h3>
During the last quarter, the company reported an EPS beat by $0.50, leading to a 5.06% drop in the share price on the subsequent day.
Here's a look at BioXcel Therapeutics's past performance and the resulting price change:

<table>
<thead>
<tr>
<th>Quarter</th>
<th>Q2 2024</th>
<th>Q1 2024</th>
<th>Q4 2023</th>
<th>Q3 2023</th>
</tr>
</thead>
<tbody>
<tr>
<td>EPS Estimate</td>
<td>-0.71</td>
<td>-0.70</td>
<td>-0.91</td>
<td>-1.31</td>
</tr>
<tr>
<td>EPS Actual</td>
<td>-0.21</td>
<td>-0.87</td>
<td>-0.76</td>
<td>-1.58</td>
</tr>
<tr>
<td>Price Change %</td>
<td>-5.0%</td>
<td>-9.0%</td>
<td>4.0%</td>
<td>4.0%</td>
</tr>
</tbody>
</table>

<img src="https://www.benzinga.com/files/images/story/2024/1731510157_0.png" alt="eps graph" />
<h3>Stock Performance</h3>
Shares of BioXcel Therapeutics were trading at $0.665 as of November 12. Over the last 52-week period, shares are down 84.48%. Given that these returns are generally negative, long-term shareholders are likely upset going into this earnings release. 
<a href="https://www.benzinga.com/quote/BTAI/earnings">To track all earnings releases for BioXcel Therapeutics visit their earnings calendar on our site.</a>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

What's Next: BioXcel Therapeutics's Earnings Preview

SERENITY At-Home Pivotal Phase 3 trial
<ul>
<li>Designed to evaluate the safety of a 120 mcg dose of BXCL501 in the at-home setting for agitation associated with bipolar disorders or schizophrenia
<ul>
<li>The first patient has been randomized.</li>
<li>The Company&nbsp;announced <a href="https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-initiation-serenity-home-pivotal">trial initiation</a> on September 5, 2024, with an expected trial duration of 9 to 12 months.</li>
<li>The double-blind, placebo-controlled, 12-week outpatient trial is expected to enroll approximately 200 patients residing at home.</li>
</ul>
</li>
</ul>
TRANQUILITY In-Care Pivotal Phase 3 trial
<ul>
<li>Designed to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 for AAD over a 12-week period
<ul>
<li>Received feedback from the U.S. Food and Drug Administration on proposed protocol</li>
<li>The double-blind, placebo-controlled study trial is expected to enroll a total of approximately 150 patients aged 55 years and older across the spectrum of Alzheimer's disease severity with mild, moderate, and severe dementia with mini-mental state examination (MMSE) scores of 0 to 25 who reside in skilled nursing facilities, memory care units, or assisted living facilities.</li>
<li>The trial is expected to enroll patients with episodic agitation, with patients self-administering 60 mcg of BXCL501 or placebo when agitation episodes occur over the trial period.</li>
<li>The planned primary endpoint is a change from baseline in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score at two hours post-first dose. This is the same endpoint used in previous TRANQUILITY trials and in studies that supported the FDA approval of IGALMI&#x2122; (dexmedetomidine) sublingual film.</li>
<li>Continued efficacy evaluations are expected to be conducted through performing additional PEC and complementary efficacy measures, including the global impression of change in agitation.</li>
</ul>
</li>
</ul>

Biotech

Health Care

General

BioXcel Therapeutics Announced The Achievement Of Clinical And Regulatory Progress For Its Pivotal Phase 3 Trials Of BXCLl501 For The Acute Treatment Of Agitation Associated With Bipolar Disorders Or Schizophrenia (SERENITY At-Home) And Agitation Associated With Alzheimer's Dementia (TRANQUILITY In-Care)

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 $7 to $5.

Price Target

Analyst Ratings

HC Wainwright & Co. Maintains Buy on BioXcel Therapeutics, Lowers Price Target to $5

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

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.

Reiteration

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

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

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

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

H.C. Wainwright lowered the firm's price target on BioXcel Therapeutics (BTAI) to $5 from $7 and keeps a Buy rating on the shares. The firm reduced...

BioXcel Therapeutics price target lowered to $5 from $7 at H.C. Wainwright

BioXcel Therapeutics (BTAI) announced the achievement of clinical and regulatory progress for its pivotal Phase 3 clinical trials of BXCL501 for th...

BioXcel Therapeutics advances Phase 3 trials of BXCL501

BioXcel Therapeutics Q3 2024 Earnings Preview

Here's the major earnings before the open tomorrow

BioXcel Therapeutics GAAP EPS of -$0.32 beats by $0.23, revenue of $0.21M misses by $1.12M

Reports Q3 revenue $214,000, consensus $1.33M. "Our focus continues to be the clinical development of BXCL501," said Vimal Mehta, Ph.D., CEO of Bio...

BioXcel Therapeutics reports Q3 EPS (32c), consensus (48c)

BioXcel Therapeutics, Inc. (BTAI) Q3 2024 Earnings Call Transcript

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Press Releases

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

BioXcel Therapeutics to Present at ThinkEquity Conference

BioXcel Therapeutics to Report Third Quarter 2024 Financial Results on November 14, 2024

BioXcel Therapeutics Advances Pivotal Phase 3 Trials of BXCL501 for Acute Treatment of Agitation Associated with Bipolar Disorders, Schizophrenia, and Alzheimer's Dementia

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