BTAI

FDA accepted sNDA for IGALMI® use in at-home (outpatient) setting; set Nov. 14, 2026, as PDUFA date Advancing BXCL501 as a potential acute treatment for agitation associated with Alzheimer’s dementia Evaluating strategic options with an advisor to maximize shareholder value and advance the commercial and development plans for IGALMI NEW HAVEN, Conn., May 15, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today provided a business update and reported financial results for the first quarter of 2026. In the quarter ended on March 31, the FDA accepted the Company’s supplemental New Drug Application (sNDA) for IGALMI® for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia and assigned a PDUFA target action date of November 14, 2026. “The first quarter was marked by tremendous progress, achieving a major regulatory milestone and developing the IGALMI commercial launch plan for the at-home setting,” said Vimal Mehta, Ph.D., Chief Executive Officer of BioXcel Therapeutics. “We are very pleased with the recent approval of another product in Alzheimer’s agitation, in an area adjacent to our focus on the acute treatment of agitation in Alzheimer’s dementia with BXCL501. Our first-in-class mechanism has the potential to make a transformative impact on the lives of a large patient population in this disease area. We are actively pursuing strategic options to maximize shareholder value for the IGALMI franchise.” Strategic Options Exploring Value-Maximizing Options: The Company engaged MTS Health Partners as an advisor for evaluation of strategic options to maximize shareholder value and advance the commercial and development plans for IGALMI, which may include, but are not limited to, a sale of the Company, a merger or other business combination, a collaboration, joint venture, royalty or license agreement of all or a portion of our assets, a recapitalization or other financing transaction, or continued execution of our standalone operating plan. We have not made a decision to pursue any specific transaction or strategic option, no set timetable has been established for the completion of this process, and there can be no assurance that the process will result in any transaction or othe...

CorMedix (CRMD) came out with quarterly earnings of $0.43 per share, beating the Zacks Consensus Estimate of $0.35 per share. This compares to earnings of $0.3 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +24.64%. A quarter ago, it was expected that this pharmaceutical and medical device company would post earnings of $0.86 per share when it actually produced earnings of $0.61, delivering a surprise of -29.07%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. CorMedix, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $127.43 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 16.00%. This compares to year-ago revenues of $39.08 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. CorMedix shares have lost about 35.5% since the beginning of the year versus the S&P 500's gain of 8.8%. While CorMedix has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for CorMedix was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of tod...

BioXcel Therapeutics, Inc. (BTAI) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.59 per share in its upcoming report, which represents a year-over-year change of +60.7%. Revenues are expected to be $0.29 million, up 70.6% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 10.26% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings...

sNDA submitted seeking approval of IGALMI® in the at-home (outpatient) setting for the treatment of acute agitation associated with bipolar disorders or schizophrenia sNDA submission timeline supports potential approval as early as year-end 2026 Advancing commercial and launch plans based on third-party market assessment NEW HAVEN, Conn., March 27, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today reported financial results for the fourth quarter and full-year 2025 and provided an update on its late-stage pipeline and commercial launch readiness plans. The Company submitted a supplemental New Drug Application (sNDA) in January to the U.S. Food and Drug Administration (FDA) seeking label expansion of IGALMI for the acute treatment of agitation associated with bipolar disorders and schizophrenia in the at-home setting. The Company is also developing commercial strategy and launch plans for IGALMI in the at-home setting, following completion of a comprehensive market assessment. “2025 was a successful year for our Company, setting the stage for the potential label expansion of IGALMI in the at-home setting and continuing progress with commercial plans for the potential launch of IGALMI,” said Vimal Mehta, Ph.D., Chief Executive Officer of BioXcel Therapeutics. “Our confidence in the substantial market opportunity in the at-home setting, where there are no FDA-approved options available, is reiterated by our recent market opportunity assessment. We also remain focused on advancing our Alzheimer’s dementia program, which is another large market opportunity.” BXCL501 Late-Stage Clinical Programs SERENITY Program IGALMI At-Home sNDA Submission: The Company submitted an sNDA in January to the FDA seeking to expand the IGALMI label for the at-home treatment of acute agitation in bipolar disorder and schizophrenia. The filing is supported by the SERENITY At-Home pivotal Phase 3 trial. Advancing Commercial Preparations: As part of the commercial preparation efforts, the Company appointed Mark Pavao as Interim Chief Commercial Officer to lead the development and execution of the launch plans for IGALMI in the at-home setting. Market Opportunity Assessment: BioXcel Therapeutics is progressing commercial preparation efforts, supp...

NEW HAVEN, Conn., March 05, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today announced positive topline results from a Phase 2 investigator-sponsored trial (IST) evaluating BXCL501 for the treatment of opioid withdrawal symptoms in adults with opioid use disorder (OUD) undergoing a methadone taper. The study suggested that BXCL501 may be as effective as or superior to lofexidine (Lucemyra®) for reducing the symptoms of opioid withdrawal during methadone taper, while having a more convenient dosing regimen and demonstrating a favorable tolerability profile. In this study, BXCL501 had similar or lower overall rates of cardiovascular (CV) effects than lofexidine. Specifically, the most common CV adverse event for Lucemyra, orthostatic hypotension, was significantly lower for the 180 µg twice daily (BID) BXCL501 dose group (18% vs 50% lofexidine, p<0.05) and remained lower in the highest 240 µg BID BXCL501 dose group (37%) over the seven-day dosing period. There were no reports of sedation or somnolence in the BXCL501 treatment arms (5% reported sedation in the lofexidine arm). These results support potential future development of BXCL501 in opioid withdrawal. These findings build on the earlier Company-sponsored Phase 1b/2 study, RELEASE,1 which established the tolerability profile of selected BXCL501 doses in opioid-dependent patients and extend those results into a clinically distinct setting that included a methadone taper and an active comparator. The results are consistent with the mechanism of action of BXCL501 (alpha 2-adrenergic receptor agonism), as locus coeruleus drives various opioid withdrawal symptoms.2 These results strengthen the growing body of evidence supporting BXCL501 across multiple potential indications, reinforcing its potential as a “pipeline within a product.” These findings build on positive results from Phase 3 pivotal studies evaluating BXCL501 for the treatment of acute agitation associated with bipolar disorder and schizophrenia, as well as Alzheimer’s disease. For this National Institute on Drug Abuse (NIDA)-funded study, BioXcel Therapeutics supplied BXCL501. This study was planned as a 4-arm trial: BXCL501 180 µg BID or 240 µg BID, placebo, and lofexidine 0.54 mg QID as a positive con...

sNDA submission expected in early Q1 2026 for expanded usage of IGALMI® in home setting based on positive data from the SERENITY At-Home trial NEW HAVEN, Conn., Nov. 12, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today reported financial results for the third quarter of 2025 and provided an update on its late-stage agitation clinical development programs. As part of this update, the Company said it plans to submit early in the first quarter of 2026 a supplemental New Drug Application (sNDA) seeking FDA approval for the at-home use of IGALMI® for the acute treatment of agitation associated with bipolar disorders or schizophrenia. In addition, the company has taken additional steps toward the initiation of the TRANQUILITY In-Care Phase 3 Trial evaluating BXCL501 in agitation associated with Alzheimer’s dementia. “We are focused on the next phase of our journey, preparing for an sNDA submission and advancing pre-launch and commercial readiness activities,” said Vimal Mehta, Ph.D., the Company’s CEO. “BXCL501 has the potential to redefine the treatment of agitation, addressing an at-home market opportunity of 57 to 77 million annual episodes in the U.S. alone. This momentum lays the foundation for meaningful, long-term growth and value creation as we work to make BXCL501 accessible to patients at home, where they need it most.” BioXcel Therapeutics continues to maintain a disciplined approach to manage its cash runway in support of the planned sNDA submission and achieving key corporate milestones. BXCL501 Late-Stage Clinical Programs SERENITY Program SERENITY At-Home Phase 3 Safety Trial: Double-blind, placebo-controlled study to evaluate the safety of a 120 mcg dose of BXCL501 in patients for acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. A total of 246 patients were randomized, and data was collected on 2,628 agitation episodes in 215 patients. No discontinuations due to tolerability in the BXCL501 arm. Adverse event profile consistent with approved IGALMI® label and multiple clinical trials in the institutional setting. No drug-related serious adverse events (SAEs), syncopes or falls reported. No new or unexpected treatment emergent adverse events (TEAEs). No sever...

Completes clinical trials required by FDA for sNDA submission planned for the first quarter of 2026 NEW HAVEN, Conn., Oct. 14, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced positive results from the correlation study related to exploratory efficacy outcomes from the SERENITY At-Home trial. The results, along with the data from the SERENITY At-Home trial, will be included in the supplemental New Drug Application (sNDA) submission that is planned for the first quarter of 2026. The standard method for measuring acute agitation associated with schizophrenia and bipolar disorder is the Positive and Negative Syndrome Scale – Excited Component (PEC) administered by a trained clinician, which was used in the Serenity I & II Pivotal Trials. In order to evaluate BXCL501 for continued clinical effect with repeat dosing in the at-home setting using an exploratory efficacy measurement, the Company, in consultation with FDA, developed the modified CGI-S (mCGI-S) scale, which can be scored by patients and/or caregivers. The study assessed the correlation between PEC and mCGI-S in this prospective, open label, in-clinic trial in 33 patients. The results demonstrated a strong correlation between the clinician assessments and the patient or caregiver (informant) rated outcomes, providing support for using mCGI-S to assess efficacy in the outpatient setting. A statistically significant and strong correlation between the PEC and mCGI-S with a correlation of ρ=0.89; p<0.0001 for patients and ρ=0.88; p<0.0001 for informants was observed. “We are pleased with the strong and significant correlation observed with clinician assessment for both patients and informants, providing support for our exploratory efficacy outcomes in the SERENITY At-Home study.” said Dusan Kostic, Ph. D. Senior Vice President Medical Affairs and Clinical Development. “We plan to include these findings as a part of our upcoming sNDA package.” There were no serious adverse events reported and the safety profile remains consistent with the IGALMI® label. Additional data and results will be presented at upcoming medical meetings and conferences. About Modified Clinical Global Impression – Severity Scale (mCGI-S) The original clinician rated CGI-S scale describes...

Company to host conference call at 8 a.m. ET, August 27, 2025 NEW HAVEN, Conn., Aug. 26, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it will host an investor call and live webcast at 8 a.m. ET, August 27, 2025 to review topline data from the SERENITY At-Home Pivotal Phase 3 trial evaluating the safety of BXCL501, the Company’s proprietary, sublingual film formulation of dexmedetomidine, as an acute treatment for agitation associated with bipolar disorders or schizophrenia in the at-home setting. The data will be disseminated in a morning press release and presented during the investor call/webcast. To access the webcast, please use the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=S598spob, or dial in at 877-407-5795 / +1 201-689-8722. A link to the webcast and accompanying presentation materials will also be available on the Investors section of the corporate website, bioxceltherapeutics.com, and a replay will be available through November 26, 2025. About the SERENITY At-Home Phase 3 Trial The trial was designed to study 200 patients with a history of agitation episodes despite being on stable treatment for their underlying bipolar or schizophrenia residing at home either alone or with caregivers/informants. Patients were required to self-administer 120 mcg of BXCL501 (the approved dose under medical supervision) or placebo when they experienced agitation episodes over the 12-week trial period, and their safety data (adverse events) was collected during the trial. In addition, patients or caregivers/informants completed a modified global impression of severity (mCGIs) two hours after dosing as an exploratory endpoint to assess their experience in the outpatient setting. About BXCL501 Outside 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 schizophre...

Explore BioXcel Therapeutics's Fair Values from the Community and select yours Net loss: US$19.2m (loss widened by 131% from 2Q 2024). US$2.45 loss per share. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 44%. Earnings per share (EPS) also missed analyst estimates by 32%. Looking ahead, revenue is forecast to grow 66% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are up 105% from a week ago. It is worth noting though that we have found 7 warning signs for BioXcel Therapeutics (5 are potentially serious!) that you need to take into consideration. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Topline data from SERENITY At-Home Phase 3 trial for acute treatment of agitation associated with bipolar disorders or schizophrenia expected in August FDA meeting scheduled in August and is intended to support potential sNDA submission for label expansion of IGALMI® in the at-home setting Publication of non-clinical data in Frontiers in Pharmacology suggests potential applications of BXCL501 in chronic conditions BioXcel Therapeutics strengthens cash position NEW HAVEN, Conn., Aug. 12, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today reported its financial results for the second quarter of 2025 and announced that its SERENITY At-Home pivotal Phase 3 safety trial for acute treatment of agitation associated with bipolar disorders or schizophrenia was complete. Topline results from the study are expected in August. "We are incredibly excited about the upcoming top-line data readout for our SERENITY At-Home Phase 3 trial – our primary market research and preliminary results regarding the frequency of agitation episodes during the trial suggest a target addressable market meaningfully larger than our original estimate of 23 million agitation episodes in the at-home setting annually,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “This expanded opportunity estimate presents a significant prospect to help many bipolar disorder and schizophrenia patients, fulfilling our core mission." BXCL501 Late-Stage Clinical Programs SERENITY Program 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 enrolled more than 200 patients across 22 sites nationwide, with no single site enrolling more than 11% of the total patient population. The vast majority of patients dosed completed the full 12-week study. Data from more than 2,200 agitation episodes was collected. The distribution of enrolled patients was balanced between the two patient populations, bipolar disorders and schizophrenia. The trial received two favorable recommendations from the Data Safety Monitoring Board (DSMB). TRANQUILITY Prog...

Enrollment complete in SERENITY At-Home pivotal Phase 3 safety trial for acute treatment of agitation associated with bipolar disorders or schizophrenia Topline data expected in second half of 2025 intended to support potential sNDA submission for label expansion of IGALMI® in the at-home setting NEW HAVEN, Conn., May 12, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today reported its financial results for the first quarter of 2025 and announced that its SERENITY At-Home pivotal Phase 3 safety trial for acute treatment of agitation associated with bipolar disorders or schizophrenia is fully enrolled. “We are pleased to have achieved this major milestone in our first trial of BXCL501 in the at-home setting,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “An estimated 23 million episodes of bipolar or schizophrenia-related agitation occur annually1-3 at home, yet there are no FDA-approved acute treatment options for patients in this setting. We look forward to a data readout expected in the second half of this year and are excited by the opportunity to expand the market potential of IGALMI® and bring this drug to millions of additional patients.” BXCL501 Late-Stage Clinical Programs SERENITY Program SERENITY At-Home Phase 3 Trial: 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 is complete: More than 165 patients have been dosed. More than 115 patients have received multiple doses for agitation over the 12-week trial period. A Data Safety Monitoring Board (DSMB) meeting is scheduled for mid-May. Topline data is expected in the second half of 2025. TRANQUILITY Program TRANQUILITY In-Care Phase 3 Trial: designed as a double-blind, placebo-controlled study to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 for acute treatment of agitation associated with Alzheimer’s dementia in the care setting. The program remains part of the Company’s broader development strategy. The Company is advancing plans for trial initiation. Corporate Updates IGALMI® Market Presence The Company is continuing to supply IGALMI® to patient...

Net loss: US$59.6m (loss narrowed by 67% from FY 2023). US$23.51 loss per share (improved from US$98.35 loss in FY 2023). All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 20%. Earnings per share (EPS) exceeded analyst estimates by 18%. Looking ahead, revenue is forecast to grow 52% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 9.0% from a week ago. You should always think about risks. Case in point, we've spotted 6 warning signs for BioXcel Therapeutics you should be aware of, and 4 of them are a bit concerning. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.