BioXcel Therapeutics 주식 (NASDAQ: BTAI)

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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.

BioXcel Therapeutics, Inc. - Common Stock

BioXcel Therapeutics Inc

- 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,&nbsp;today announced that an independent Data Safety Monitoring Board (DSMB) recommended that the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia continue without modification.
The DSMB recommendation followed a review of unblinded safety data from the first 115 patients dosed as of the May 2, 2025 cutoff date. The trial is fully enrolled and collection&nbsp;of data over&nbsp;the&nbsp;12-week period is continuing.
"We are pleased with the favorable DSMB meeting outcome and are excited about the upcoming data readout for our first at-home trial with BXCL501," said Vimal&nbsp;Mehta, Ph.D., CEO of BioXcel Therapeutics. "Results are intended to help support a potential sNDA submission for label expansion of IGALMI&#xAE;&nbsp;in the at-home setting — a sizeable unmet medical need given there are no FDA-approved therapies for bipolar or schizophrenia-related agitation in this environment."
The SERENITY At-Home Phase 3 trial is designed as a double-blind, placebo-controlled study to evaluate the safety of a 120 mcg dose of BXCL501 in 200 patients for acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting.
<ul>
<li>Trial enrollment is complete:
<ul>
<li>More than 205 patients have been dosed.</li>
<li>More than 150 patients have received multiple doses for agitation over the 12-week trial period.</li>
</ul>
</li>
<li>Topline data expected in Q3 2025.</li>
</ul>
 Additional information on the SERENITY At-Home trial is included in a&nbsp;<a href="https://www.globenewswire.com/Tracker?data=9G1Lp2ys-yU8kHSohL4bQmaTZ1BS3zNda9QGdShHRylVjV3gr52B8lL_z1TZiIi-HEYwSEYhtaIu0HTmrmX7yfAxLaoplRxV0F1iBuykkC4fB-lUToUFetj-ZUlsQ9-B-rpW6UbSXvdeOalFQ19mwp8qIMB7WZ7QyQNzNjA3cF_0FADNETCuwzR5asPgRJmr5e8NOfJwuowNz8uXot2fpgyNRaIfz60C0bEf_FyW5kl0tHPrfr-u4tCnVUvIx2TQxC6Bo0wijRRFCLNxDH5p029dhSdv5GeLzL7YtKM_RrDc2TrVc2Y5CzZJCvdUvIXjMc8eDWF4SBnUgmDtCZzbkEcAm7v-XKByiP4nc4JGRx8Tm8oI1IIy3KaSHuN2lZcX">corporate presentation</a>&nbsp;in the Investors section of the Company's website:&nbsp;<a href="https://www.globenewswire.com/Tracker?data=HnXJ3tIc5X5GEv5RjBBV33QYwPQDW6F1-oCiOaVEt2tKvUwcKtUO2WWjiAYxXvO6GCU0MMBl3bv5CvVcqpNPkg5X1TbWWOneMsyFY2YnasqFUo5hSvu-_G4ZPjDDs8kosMBOlzr_5m4lQz19yEkKqv5TuqmMQ0XZm8s1z4Y72DI7vy2i7x8xhLTtvvs09wFEQyfsLbheY731KEuDR1Mpvmi-pimWe-rb0576dwVXYE-hdEO2q7xw0IWD7p0FbjSGhvjtlLyQmiqS9zJO7ubmiJLizdMWRpEy7g6Y-ISJZIUXvcuMBwXk0zoXK-q8Fek7gs4mkdL0IlyYbM6h9hcHabCVKmYiYrR8QCzfFK69W5hllLQgBk04MUdNMG0zllfBk6TL1gd-7hCMr_IM4L-D6zYgXnAKN9pTN9mFM_R5V7HcbOwDkIsWzaFxb64GG_MkV5-o-AabUwJ6NHtHgbEACBDFWEiJPC4GiaD6LHNF7Ycvc5dvexy02UEQLO9rTwR8CkI2-qh_iVYJzrpvYxHqoaSybN3Noju8DvdHBHlwPIiYeinsKru83G0OiwTon4t3R-TDfk9tLGu3e_Nj4vct1KeHbDBw3C-hIvDe6oZLmWVf5-SAyrGyy30TavjgrWNQp9N8mDHueFJw9mf0TsTBcWeOCTdDlW60kCmIxE4z4ftVbTYVDMDxqmo9JrGQz0Phfj_TUdge3w5ft24z6sjm-lDorlVB7dEuCGH_P5dKWgMTgo8OMHVshJudrpouWTihurT68iiMpYc1vuoNRD29lm6uEMg0sAMoNd9W6SB9PApBGo-m1ww8_RKVERyCNEpmwKNbVph5m0o--DhrZE3ssXNExFCVNN0wPOqLSAiES7OKz7ZKkBpxzWo_7FRXaHdJMBPCqbMVXO4vWRdRetLc8zhQRG0n-KFuq8VvoWfvptbI2PdL5yrLAb916eioEs9SIMchTlucHd5ssw7Lk61XtwU6i395a02qOMTt6DJdcQlPrB_elYMQbS9XvsEp_yNrcEEtkYiEJdTmXQu8AduQzYiIeScIzvBqTznfuNGhRXyfFDvmrvE1-ga8izW_ZjcxSX0-5YahQBeegeu2Q1d24ziV8v6MiQt7P2uFPQ9cnLSjGkuUSmwDEiYZnLK4b6Jo8hdR5Q-6ubo-f49mFzRflpC8pUtbn6WexPhvPUZxLObTs2BZUPpn0bqGPUt3Cuq8gjEHoI0nrvnTatsiSTrGFZXv7yc70JIfRe4Ybdkv_noMMynX1-FNkAd1fsnxxwllD_BJn-yNSxcdGa4P2K9_oxqSiqnhyNtAAVyQiy4t5KV3EQE0KCWoEdy5JWVTdFEziHQj7FLl8SWHdE0KtloP2L-PIlGjzr5Q24ZcKsaznK9kwS_-YAxZIT8cB-ZiVjS76MOCDqv8qmcpPZPttzlyNTwSVkhEMTxkKfyYU18agkvFF8rYjHeamsooBxNo64ynedx3eYMzIHWnoY3wNpWiCdsWcNTN8xAI3sTOFogucGpflgJi0SX9ig6MHVoIMoedvdcNOQhHviTZrDmfSZSGyOtzVOm7aX5dD38fi1BUCWCrQctIx2gYgHnL_swIVhcxzSLQiF5hrT2Ao6qQSvNONVj9NWB_r9HPg3qIB0VWgv1yp38dPmFF-EbCU4ZjpUH4jq7dlM0CYEqEowNkHix2LuClMsxnMeyu_jt0CB6tc7o7Yr10jlVgjH7s6MMIN-y-bHntrgNmutWD6YN8NEWhgJZ_QaE6_DParOqsQhVBS5TRCJtP694REBOrGc7KrqIXMs4iJe2CRVyrb749Yk2npKxg5L6Gw1FmApT2AFOueKg=">bioxceltherapeutics.com</a>.
About BXCL501 Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI&#xAE; (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer's dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.
About the SERENITY At-Home Phase 3 Trial The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The trial is designed to evaluate 200 patients with a history of agitation episodes residing at home either alone or with caregivers/informants. Patients are self-administering 120 mcg of BXCL501 or placebo when agitation episodes occur over the 12-week trial period, with safety data (adverse events) collected during the trial. In addition, patients or caregivers/informants will complete a modified global impression of severity (mCGIs) and a clinical global impression of change (mCGI-C) two hours after dosing as an exploratory endpoint to evaluate use in the outpatient setting.
About IGALMI&#xAE; (dexmedetomidine) sublingual film&nbsp;&nbsp; &nbsp;&nbsp; INDICATION&nbsp;
IGALMI&#xAE; (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children.&nbsp;
IMPORTANT SAFETY INFORMATION&nbsp;
IGALMI can cause serious side effects, including:&nbsp;
<ul>
<li>Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint.&nbsp;</li>
<li>Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations.&nbsp;</li>
<li>Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI.&nbsp;</li>
<li>Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours.&nbsp;</li>
</ul>
 &nbsp;

Biotech

News

General

BTAI

Bioxcel Therapeutics Announces That An Independent Data Safety Monitoring Board Recommended That The Serenity At-Home Pivotal Phase 3 Safety Trial Of BXCL501 For Acute Treatment of Agitation Associated With Bipolar Disorders Or Schizophrenia Continue Without Modification.

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,&nbsp;today announced that the Nasdaq Hearings Panel granted the Company's request to continue its listing on&nbsp;The Nasdaq Stock Market.
During a Nasdaq Panel hearing held on May 1, 2025, the Panel reviewed the Company's plan and strategies to regain compliance with Listing Rule 5550(b)(2) (the "MVLS (market value of listed securities) Rule"). As a result of the hearing, the Panel granted the Company's request for continued listing on The Nasdaq Stock Market and provided the Company until September 16, 2025 to regain compliance, subject to the Company meeting certain interim conditions. BioXcel Therapeutics is committed to executing on its compliance plan to meet the applicable requirements within the specified time frame.

Government

Regulations

BioXcel Therapeutics Wins Nasdaq Extension, Has Until September to Regain Listing Compliance

BioXcel Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BTAI#NASDAQ">BTAI</a>) reported quarterly losses of $(1.50) per share which beat the analyst consensus estimate of $(4.16) by 63.94 percent. This is a 89.22 percent increase over losses of $(13.92) per share from the same period last year. The company reported quarterly sales of $168.00 thousand which missed the analyst consensus estimate of $426.67 thousand by 60.63 percent. This is a 71.13 percent decrease over sales of $582.00 thousand the same period last year.

Earnings

Earnings Beats

Earnings Misses

BioXcel Therapeutics Q1 EPS $(1.50) Beats $(4.16) Estimate, Sales $168.00K Miss $426.67K Estimate

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

Trading Ideas

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.

Movers

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>

Health Care

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.

Financing

Press Releases

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

Small Cap

WHO and WEF Are Pushing AI in Global Healthcare -- What It Means for the Market

BioXcel Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update

BioXcel Therapeutics Granted Extension to Regain Compliance with Nasdaq Continued Listing Requirement

BioXcel Therapeutics Receives Positive Recommendation from Data Safety Monitoring Board (DSMB) to Continue SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

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