Dexmedetomidine Hydrochloride

DSMB recommended the continuation of trial as planned Topline data expected in Q3 2025 NEW HAVEN, Conn., July 01, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced the second positive recommendation by an independent Data Safety Monitoring Board (DSMB) to continue, without modification, the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia. The DSMB recommendation followed a review of unblinded safety data from 178 patients dosed as of the May 28, 2025 cutoff date. The trial is fully enrolled and collection of data over the 12-week period is continuing. “We are pleased with this additional favorable recommendation from the DSMB regarding our first at-home trial of BXCL501 and look forward to the upcoming data readout,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “Bipolar and schizophrenia-related agitation in the at-home setting is a large, unmet medical need, with no FDA-approved therapies. We are highly motivated to address this need for millions of patients, with trial data intended to support a potential sNDA submission to expand the IGALMI® label in the at-home setting.” 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. Trial enrollment was completed in May, 2025Topline data expected in Q3 2025. Additional information on the SERENITY At-Home trial is included in a corporate presentation in the Investors section of the Company’s website: bioxceltherapeutics.com. About BXCL501Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (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 TrialThe 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 exploratory endpoints to evaluate use in the outpatient setting. About IGALMI® (dexmedetomidine) sublingual film INDICATION IGALMI® (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. IMPORTANT SAFETY INFORMATION IGALMI can cause serious side effects, including: 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. 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. 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. 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. The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing. These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects. Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids. Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201-1088 or medinfo@bioxceltherapeutics.com. Please see full prescribing information at Igalmi.com. About BioXcel Therapeutics, Inc.BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: the Company’s planned advancement of its SERENITY trial; potential market opportunity for BXCL501; completing enrollment and release of topline data from the ongoing SERENITY trial; submission of an sNDA; expanding the IGALMI® label in the at-home setting; the potential for the results from the Company’s completed, ongoing and proposed clinical trials to support regulatory approvals for its product candidates. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. 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. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. 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; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI®, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of agitation and the size of the Company’s total addressable market may be overestimated, and approval that the Company may obtain may be based on a narrower definition of the patient population; its lack of experience in marketing and selling drug products; the risk that IGALMI or the Company’s product candidates may not be accepted by physicians or the medical community in general; the Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI; 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; undesirable side effects caused by the Company’s product candidates; its novel approach to the discovery and development of product candidates based on EvolverAI; the significant influence of and dependence on BioXcel LLC; its exposure to patent infringement lawsuits; its reliance on third parties; its ability to comply with the extensive regulations applicable to it; impacts from data breaches or cyber-attacks, if any; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, 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 and the Investors section of the Company’s website at www.bioxceltherapeutics.com. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company 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. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Contact Information InvestorsRusso PartnersNic Johnson1.303.482.6405 MediaRusso PartnersDavid Schull1.858.717.2310 Source: BioXcel Therapeutics, Inc.IGALMI® is a registered trademark of BioXcel Therapeutics, Inc.

Equity Insider News Commentary Issued on behalf of Avant Technologies Inc. VANCOUVER, BC, May 30, 2025 /PRNewswire/ -- The concept of AI in healthcare is no longer a novelty, experts are acknowledging AI algorithms, detection, and drug discovery are becoming indispensable tools. As medical errors continue to harm patients, healthcare experts are turning to AI to improve mistakes in medications, such as prescribing the wrong drug or wrong dose. As real-world deployment gains momentum, a number of tech and biotech firms are already translating AI healthcare innovation into clinical practice. Notable recent activity includes initiatives from Avant Technologies, Inc. (OTCQB: AVAI), Tempus AI, Inc. (NASDAQ: TEM), BioXcel Therapeutics, Inc. (NASDAQ: BTAI), Healwell AI Inc. (TSX: AIDX) (OTCPK: HWAIF), and WELL Health Technologies Corp. (TSX: WELL) (OTCQX: WHTCF). Continue Reading Real-World Deployments Signal AI Healthcare Is Ready for Scale Cathie Wood of Ark Invest recently highlighted new research from Mass General Brigham, where AI models were able to predict cancer survival outcomes based on facial images—an example she cited as evidence that healthcare could become AI's most transformative use case. Industry forecasts support that trajectory, with Statista estimating that the global AI healthcare market will grow from roughly $11 billion today to $188 billion by 2030, reflecting a compound annual growth rate of 37%. Avant Technologies, Inc. (OTCQB: AVAI), in collaboration with Ainnova Tech, is quietly building a foothold in the emerging field of predictive diagnostics. Its Vision AI platform is designed to identify disease markers at the earliest possible stage—sometimes before outward symptoms emerge—by leveraging artificial intelligence in combination with clinical data. In its latest move, Avant disclosed plans to integrate a patented technology that targets early-stage dementia detection, signaling an intentional broadening of its preventive care focus. The proposed tool uses proprietary algorithms alongside hardware and a five-minute blood test to flag dementia-associated risk factors well in advance of standard clinical methods. Avant is weighing both licensing and acquisition options for the technology, with global rights under consideration. Either route would strengthen the company's position in the neurodegenerative care space and complement its broader push into chronic illness screening. By expanding its platform's range without departing from its central thesis—early, accessible intervention— Avant is quietly aiming to reshape how and when critical conditions are first detected. "This accessible, fast, and scalable solution is designed to support early intervention and targeted treatment strategies, with the ambition of reaching millions of patients globally in the coming years," said Vinicio Vargas, CEO at Ainnova and member of the Board of Directors of the joint venture company, Ai-nova Acquisition Corp. (AAC). "Adding the early detection of dementia that this patented technology presents us would go a long way to making us a leader in the industry of early disease detection." Vision AI is designed as a non-invasive platform that brings together retinal imaging, blood pressure readings, and routine lab data to generate personalized health assessments. Its core function is to estimate risk for common but often underdiagnosed chronic conditions—helping clinicians make earlier, more informed decisions with minimal burden on the patient. By analyzing just two retinal images and a short set of vital signs, the system runs four proprietary algorithms trained on more than 2.3 million clinical records. These algorithms evaluate indicators linked to cardiovascular disease, type 2 diabetes, liver fibrosis, and chronic kidney disease. The technology's lightweight, modular design is intended to keep costs low while enabling use across a wide range of clinical settings—including those with limited access to specialist care. "Our purpose is to create the future of early disease detection in an accessible way, so that patients can get a preventive check-up anywhere, at a low cost, and easily," said Vargas in a previous statement. "We want to prevent patients with risk factors from developing other diseases that could have been avoided before they became a real problem. To this end, we are seeking to integrate new technologies into our portfolio within a single platform, both through our R&D efforts and through potential exclusive licenses or acquisitions." Alongside its dementia screening initiative, Avant is progressing toward a full acquisition of Ainnova Tech, its current development partner. The two firms are already operating under a shared entity— Ai-nova Acquisition Corp. (AAC)—and a completed merger would align leadership, simplify corporate structure, and create a more efficient framework for navigating regulatory milestones. A key FDA pre-submission meeting is scheduled for July, making the timing of this integration especially relevant. Internally, management views the consolidation as a strategic lever to accelerate U.S. market access while continuing to support ongoing deployments in international pilot programs. "This milestone reflects our two-tiered strategy, rapid deployment in low-regulation markets where Vision AI operates as a screening tool, and simultaneous progress toward FDA clearance for the U.S. market," said Vargas. "Entering the U.S. will unlock significant commercial potential, and early engagement with regulators ensures we do so with speed, credibility, and a validated product." While many AI-driven diagnostic platforms remain confined to controlled pilots or lab settings, Avant's Vision AI is already operating in live clinical environments across Latin America. Active deployments in Chile, Mexico, and Brazil are generating real-world data on safety, performance, and clinical usability—insights that are feeding directly into iterative improvements across the platform. Longer term, the company aims to unify a growing range of diagnostic tools under a single, streamlined system capable of delivering early-stage health insights from basic, non-invasive inputs. Backed by global platform rights through AAC, and supported by detection sensitivity levels reported above 90% in research cited by the NIH, Vision AI is quietly shaping into a scalable solution with potential utility across both developed and underserved healthcare systems. With dementia screening now entering the pipeline and additional modules under evaluation, Avant appears to be transitioning from early validation to broader execution—laying the groundwork for international expansion and a future U.S. launch. CONTINUED... Read this and more news for Avant Technologies at: Tempus AI, Inc. (NASDAQ: TEM) has reached a major milestone, having supported close to 1,500 research projects since its founding in 2015. These efforts include around 1,000 biopharma partnerships and nearly 500 provider-led initiatives using Tempus' diagnostics, datasets, and modeling tools. The company's biological modeling lab alone has contributed to over 60 research projects focused on therapy selection and drug discovery. "From day one at Tempus, our mission has been to empower researchers with the data and insights they need to drive better outcomes," said Eric Lefkofsky, Founder and CEO of Tempus. "We have made significant progress toward that goal by delivering at a scale few others have achieved." With one of the largest libraries of multimodal data in healthcare, Tempus continues to scale its impact through AI-driven precision medicine. An independent safety board has endorsed the continuation of BioXcel Therapeutics, Inc.'s (NASDAQ: BTAI) pivotal Phase 3 SERENITY At-Home trial evaluating BXCL501 for agitation tied to bipolar disorders or schizophrenia. "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 Mehta, Ph.D., CEO of BioXcel Therapeutics. "Results are intended to help support a potential sNDA submission for label expansion of IGALMI® 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 fully enrolled trial involves over 200 patients who self-administer treatment during agitation episodes, with safety data tracked over 12 weeks. More than 150 participants have already received multiple doses. Topline results are slated for release in the third quarter of 2025 and may inform a future regulatory submission. Three subsidiaries under Healwell AI Inc. (TSX: AIDX) (OTCPK: HWAIF) and WELL Health Technologies Corp. (TSX: WELL) (OTCQX: WHTCF) have been selected as winners in Canada Health Infoway's 2025 Vendor Innovation Program, making up nearly half of the total awardees. The selected projects—Pentavere, Intrahealth, and OceanMD—are focused on real-world interoperability solutions that improve clinical workflows and enhance access to actionable patient data. "Intrahealth and Pentavere's recognition through the Vendor Innovation Program demonstrates the tremendous impact HEALWELL companies are having in the digital health landscape," said Dr. Alexander Dobranowski, CEO of HEALWELL. "Both companies are at the forefront of transforming healthcare delivery with innovative solutions that enhance data-driven care coordination, streamline workflows, and empower clinicians to deliver better patient outcomes." Each initiative will be deployed across multiple provinces and settings, including rural and Indigenous communities. "We are incredibly proud to see OceanMD, as part of WELLSTAR, recognized for its innovation in improving healthcare outcomes through digital technologies," said Amir Javidan, CEO of WELLSTAR— a subsidiary of WELL Health that focuses on digital health innovation and owns OceanMD, one of the three selected projects in the Vendor Innovation Program. "This recognition is a testament to the exceptional work our team is doing in transforming patient care, and we are excited to see the impact this will have in clinical settings across Canada." This recognition highlights both companies' leadership in advancing digital healthcare infrastructure in Canada. Source: need-to-know/ CONTACT: Equity Insider [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. 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