BioXcel Therapeutics Bolsa (NASDAQ: BTAI)

Últimas noticias sobre BioXcel Therapeutics (NASDAQ:BTAI) Bolsa

BIOXCEL THERAPEUTICS INC

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.

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BioXcel Therapeutics, Inc. - Common Stock

BioXcel Therapeutics Inc

Earnings

Earnings Beats

Earnings Misses

BioXcel Therapeutics Q4 2024 GAAP EPS $(3.57) Beats $(6.59) Estimate, Sales $366K Miss $706.667K Estimate

WIIM

BioXcel Therapeutics shares are trading higher after Rodman & Renshaw initiated coverage on the stock with a Buy rating and announced a $65 price target.

Rodman &amp; Renshaw analyst Elemer Piros initiates coverage on BioXcel Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BTAI#NASDAQ">BTAI</a>) with a Buy rating and announces Price Target of $65.

Price Target

Initiation

Analyst Ratings

Rodman & Renshaw Initiates Coverage On BioXcel Therapeutics with Buy Rating, Announces Price Target of $65

Topline data expected in second half of 2025 to support potential sNDA submission for label expansion of IGALMI&#xAE;&nbsp;in the home setting
Company has $35M of cash following closing of recent equity financing

BioXcel Therapeutics Bolsters Cash Reserves To Advance SERENITY At-Home Phase 3 Trial, Topline Data Expected In H2 2025

BioXcel Therapeutics shares are trading higher after the company announced it has reached 33% enrollment in its 200-patient SERENITY At-Home trial.

BioXcel Therapeutics Announces 33% Enrollment In SERENITY At-Home Pivotal Phase 3 Safety Trial For Acute Treatment Of Agitation Associated With Bipolar Disorders Or Schizophrenia; Topline Data Expected In 2H25

BioXcel Therapeutics Shares Resumed Trade

BioXcel Therapeutics Shares Halted On Circuit Breaker To The Downside, Stock Now Up 67.6%

BioXcel Therapeutics, Inc. (the "Company") (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, today announced that it has entered into a securities purchase agreement with certain institutional investors for the purchase and sale in a registered direct offering of 4,000,000 shares (the "Shares") of common stock, par value $0.001 per share ("Common Stock") (or common stock equivalents in lieu thereof), and accompanying warrants (the "Accompanying Warrants") to purchase up to 4,000,000 shares of Common Stock at a combined offering price of $3.50 per Share (or per common stock equivalent in lieu thereof) and Accompanying Warrant, for aggregate gross proceeds to the Company of approximately $14 million before deducting the placement agent's fees and other estimated offering expenses payable by the Company (excluding the proceeds, if any, from the exercise of the Accompanying Warrants). The Accompanying Warrants have an exercise price of $4.20 per share of Common Stock, are exercisable at any time after the date of issuance, subject to certain ownership limitations, and expire five years from the date of issuance. The Company has also granted the purchasers the option, exercisable at any time and from time to time, for two weeks after the closing of this offering to purchase up to an additional 4,000,000 Shares (or common stock equivalents in lieu thereof) and Accompanying Warrants to purchase an additional 4,000,000 shares of Common Stock from the Company, at a combined offering price of $3.50 per Share (or per common stock equivalent in leu thereof) and Accompanying Warrant.
Rodman &amp; Renshaw LLC is acting as the exclusive placement agent for the offering.
The offering is expected to close on March 4, 2025, subject to customary closing conditions. The Company currently intends to use the net proceeds from the offering for working capital and general corporate purposes.

Offerings

BioXcel Therapeutics Announces $14M Registered Direct Offering of 4M Shares Of Common Stock And Accompanying Warrants At A Combined Price Of $3.50

BioXcel Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BTAI#NASDAQ">BTAI</a>) shares are trading higher Monday following news that the U.S. Food and Drug Administration has concluded its inspection of a site involved in the <a href="https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-fda-closed-its-inspection-site">company's Phase 3</a> TRANQUILITY II trial.
What To Know: The trial evaluates BXCL501 for the acute treatment of agitation associated with Alzheimer's dementia. The FDA released an Establishment Inspection Report and designated the site with a &#8220;Voluntary Action Indicated&#8221; status under 21 C.F.R.20.64(d)(3), signaling that while some minor issues may have been noted, they do not require regulatory action.
The company has also received FDA feedback on the protocol for its TRANQUILITY In-Care Phase 3 trial, which is set to evaluate BXCL501 for agitation in Alzheimer's patients residing in care facilities. The TRANQUILITY In-Care trial will assess the efficacy and safety of a 60 mcg dose of BXCL501 over 12 weeks in patients with mild to severe Alzheimer's-related dementia.
BTAI Price Action: BioXcel shares were up 117.1% at $4.68 at the time of writing, according to <a href="http://www.benzinga.com/pro/register/?utm_source=BZprocontent072624&amp;t=be2bearmibe3na1">Benzinga pro.</a>
<figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" width="1024" height="521" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/03/03131335/Screenshot-2025-03-03-at-13.13.09-1024x521.png" alt="" class="wp-image-806623" style="width:414px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/03/03131335/Screenshot-2025-03-03-at-13.13.09-1024x521.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/03/03131335/Screenshot-2025-03-03-at-13.13.09-300x153.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/03/03131335/Screenshot-2025-03-03-at-13.13.09-768x391.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/03/03131335/Screenshot-2025-03-03-at-13.13.09.png 1523w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>
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Image Via Shutterstock.

BioXcel Shares Are Up Today: What's Going On?

BioXcel Therapeutics shares are trading higher after the FDA closed its inspection of a site for the Phase 3 TRANQUILITY II trial for the acute treatment of agitation associated with Alzheimer's dementia.

BioXcel Therapeutics Shares Resume Trade Following Circuit Breaker Halt

<ul>
<li>FDA concludes site inspection is closed under 21 C.F.R.20.64(d)(3); Voluntary Action Indicated</li>
<li>Company believes this further supports reliability of data from TRANQUILITY II trial of BXCL501</li>
</ul>

Biotech

Health Care

General

BioXcel Therapeutics Announced That The FDA Concluded That The Inspection Of A Single Site In Its TRANQUILITY II Phase 3 Trial And Released The Establishment Inspection Report. The FDA Has Designated "Voluntary Action Indicated" For The Site

BioXcel Therapeutics shares are trading higher after the company announced it regained Nasdaq listing compliance.

BioXcel Therapeutics Regains Nasdaq Listing Compliance, Overcomes Bid Price Challenge

Trading Halt: Halt status updated at 8:55:00 AM ET: Quotation Resumption: News and Resumption Times

BioXcel Therapeutics shares are trading lower after the company announced a 1-for-16 reverse stock split.

Stock Split

BioXcel Therapeutics Announced That It Will Effect A 1-for-16 Reverse Stock Split At 5:00 P.M. Eastern Time On February 7

The majority of trial sites have been opened and patient enrollment is progressing with the SERENITY At-Home trial&nbsp;of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia.
Developed plans for the&nbsp;TRANQUILITY In-Care trial&nbsp;of BXCL501 for agitation associated with Alzheimer's dementia (AAD).

BioXcel Therapeutics Updates On Progress Of Its Late-stage Clinical Programs For Lead Neuroscience Asset BXCL501

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 $5 to $3.

HC Wainwright & Co. Maintains Buy on BioXcel Therapeutics, Lowers Price Target to $3

Financing

Press Releases

BioXcel Therapeutics Announces Pricing of $7.0 Million Public Offering

Management

BioXcel Therapeutics Provides Clinical and Business Update

BioXcel Therapeutics Announces Reverse Stock Split

BioXcel Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Rule

BioXcel Therapeutics Announces FDA Closed its Inspection of Site for Phase 3 TRANQUILITY II Trial for Acute Treatment of Agitation Associated with Alzheimer's Dementia

BioXcel Therapeutics Announces $14 Million Registered Direct Offering

BioXcel Therapeutics Announces Closing of $14 Million Registered Direct Offering

BioXcel Therapeutics Announces 33% Enrollment in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

BioXcel Therapeutics Strengthens Cash Position to Advance SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

BioXcel Therapeutics Reports Financial Results for the Fourth Quarter and Full Year 2024

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