Depressive Disorder, Major

WASHINGTON, May 5, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) informed Vanda that the New Drug Application (NDA) for Bysanti™ (milsaperidone) has been filed, and that at this time no potential review issues have been identified. The FDA has set February 21, 2026 as the target date for decision on this application. Bysanti™ is a new chemical entity, which was initially identified as an active metabolite of iloperidone. Vanda has discovered that milsaperidone, when administered orally, quickly interconverts to iloperidone. In clinical studies, milsaperidone and iloperidone have been shown to be bioequivalent at both low and high doses, administered both in single and multiple dose studies. The results of these clinical studies will be presented in late May, at the 2025 American Society of Clinical Psychopharmacology annual meeting in Scottsdale, Arizona. The efficacy and safety of Bysanti™ for the indications of bipolar I manic and mixed episodes and schizophrenia are supported by the clinical studies described on the iloperidone prescribing information. These include two studies in acute episodes of schizophrenia, one study in bipolar I disorder with manic or mixed episodes, and one relapse prevention study in schizophrenia. The safety of Bysanti™ is further supported by data in several thousand patients exposed to iloperidone in clinical studies, as well as the post marketing iloperidone experience, with more than 80,000 patient year exposures. The unique physical and chemical properties of milsaperidone make it amenable to the development of lipid esters that could allow the future development of long acting injectable formulations. Bysanti™ is currently under development in a clinical study as a once-a-day adjunctive treatment of major depressive disorder (MDD) for patients with inadequate response on their current treatment. Results are expected in 2026. Bysanti™ is eligible for 5 year regulatory data exclusivity if approved by the FDA. Current Bysanti™ related patent applications, if issued, would extend into the 2040's. Bysanti™ belongs to the class of atypical antipsychotics showing strong affinity to the alpha 1 adrenergic receptor, in addition to certain serotonin and dopamine receptors that are believed to explain its therapeutic effects. "The extraordinary discovery of bioequivalence to iloperidone, of this novel chemical entity, allows for the efficient development of Bysanti™ and opens new opportunities to further explore additional therapeutic applications of this molecule," said Dr. Mihael Polymeropoulos, Vanda's President, CEO and Chairman of the Board. About Bysanti™ Bysanti™ is a new chemical entity that belongs in the class of atypical antipsychotic drugs. If approved, Bysanti™ could be available for sale in the US in 2026. Bysanti™ is believed to achieve its therapeutic effect by interacting with a host of neurotransmitter receptors in the brain, including the alpha-adrenergic receptor, serotonin receptors and dopamine receptors. Exclusivity, including pending patent applications, could extend into the 2040s. About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, statements regarding the potential to develop long acting injectable formulations of Bysanti™, the expected timing of the clinical study results for Bysanti™ in MDD, Bysanti™'s mechanism of action, the potential commercial availability of Bysanti™, the potential to extend patent exclusivity for Bysanti™ into the 2040s, the potential to develop additional therapeutic applications for Bysanti™, and the anticipated timing of the completion of the FDA's review of the Bysanti™ NDA are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to complete its clinical study in MDD and report results in 2026, Vanda's assumptions regarding how Bysanti™ achieves its therapeutic effect, Vanda's ability to obtain regulatory approval for Bysanti™ for the acute treatment of bipolar I disorder and schizophrenia and initiate its commercial launch in 2026, Vanda's ability to satisfy the conditions necessary to extend Bysanti™'s patent exclusivity into the 2040s, Vanda's ability to identify additional indications for Bysanti™ and the FDA's ability to complete its review of, and reach a decision with respect to, the Bysanti™ NDA by February 21, 2026. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden/Jack Keleher/Dan Moore Collected Strategies [email protected] SOURCE Vanda Pharmaceuticals Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Total 1Q 2025 net product revenue of $121.5 million , representing 62% year-over-year growth AUVELITY® 1Q 2025 net product sales of $96.2 million , representing 80% year-over-year growth SUNOSI® 1Q 2025 net product revenue of $25.2 million , representing 17% year-over-year growth SYMBRAVO® approved for the acute treatment of migraine; commercial launch on track for June 2025 NDA for AXS-14 for the management of fibromyalgia submitted to the FDA Supplemental NDA submission for AXS-05 in Alzheimer’s disease agitation on track for 3Q 2025 NDA submission for AXS-12 for cataplexy in patients with narcolepsy anticipated in 2H 2025 Positive topline results of FOCUS Phase 3 trial of solriamfetol in ADHD announced Initiation of Phase 3 trial of solriamfetol in major depressive disorder with excessive daytime sleepiness anticipated in 2025 Positive topline results of EMERGE Phase 3 trial of SYMBRAVO in migraine patients with prior inadequate response to oral CGRP inhibitors announced Company to host conference call today at 8:00 AM Eastern NEW YORK , May 05, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced financial results for the first quarter of 2025 and provided a general business update. “The first quarter was strong and eventful, with the approval of SYMBRAVO for the acute treatment of migraine, continued growth of AUVELITY and SUNOSI, and significant advancements across our broad late-stage neuroscience pipeline,” said Herriot Tabuteau , MD, Chief Executive Officer of Axsome Therapeutics . “Commercial availability of SYMBRAVO is on track for this June, and preparations are underway to enable a successful launch. We have submitted our NDA for AXS-14 for the management of fibromyalgia, and are on track for our planned NDA submissions this year for AXS-05 in Alzheimer’s disease agitation and for AXS-12 in cataplexy in patients with narcolepsy. Our development programs with solriamfetol continue to advance, with the recently announced Phase 3 topline results in ADHD and MDD, and progress across the Phase 3 trials in binge eating disorder and excessive sleepiness associated with shift work disorder. Overall, our neuroscience portfolio positions us to deliver potentially five marketed products across ten indications that collectively impact over 150 million patients in the U.S. alone. We look forward to continued momentum over the balance of 2025 as we execute on our mission to deliver transformative medicines to patients living with serious CNS conditions.” First Quarter 2025 Financial Highlights Total net product revenue was $121.5 million for the first quarter of 2025, representing 62% year-over-year growth. Total net product revenue for the comparable period in 2024 was $75.0 million . AUVELITY net product sales were $96.2 million for the first quarter of 2025, representing 80% year-over-year growth. AUVELITY net product sales for the comparable period in 2024 were $53.4 million . SUNOSI net product revenue was $25.2 million for the first quarter of 2025, representing 17% year-over-year growth, which consisted of $24.1 million in net product sales and $1.1 million in royalty revenue associated with SUNOSI sales in out-licensed territories. SUNOSI net product revenue for the comparable period in 2024 was $21.6 million , which consisted of $20.7 million in net product sales and $0.9 million in royalty revenue. Total cost of revenue was $9.8 million for the first quarter of 2025. Total cost of revenue for the comparable period in 2024 was $6.3 million . Research and development (R&D) expenses were $44.8 million for the first quarter of 2025, compared to $36.8 million for the comparable period in 2024. The increase was primarily related to the Company’s Phase 3 trials of solriamfetol, manufacturing costs for the planned launch of SYMBRAVO, and higher personnel costs, including non-cash stock-based compensation, associated with organizational growth. Selling, general, and administrative (SG&A) expenses were $120.8 million for the first quarter of 2025, compared to $99.0 million for the comparable period in 2024. The increase was primarily related to commercialization activities for AUVELITY, including sales force and marketing expenses, pre-launch activities for SYMBRAVO, and higher personnel costs, including non-cash stock-based compensation, associated with organizational growth. Net loss for the first quarter of 2025 was $59.4 million , or $(1.22) per share, compared to a net loss of $68.4 million , or $(1.44) per share, for the comparable period in 2024. The net loss in the first quarter of 2025 includes $26.2 million in non-cash charges, comprised primarily of $23.3 million in stock-based compensation expense. Cash and cash equivalents totaled $300.9 million at March 31, 2025 , compared to $315.4 million at December 31, 2024 . Shares of common stock outstanding were 49,216,759 at March 31, 2025 . Financial Guidance Axsome believes that its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan. Commercial Highlights AUVELITY Approximately 167,000 prescriptions were written for AUVELITY in the first quarter of 2025, representing an increase of 76% compared to the same period in 2024, and an increase of 5% compared to the fourth quarter of 2024. Payer coverage for AUVELITY across all channels is approximately 78% of all covered lives. The proportion of lives covered for AUVELITY in the commercial and government (Medicare and Medicaid) channels are approximately 63% and 100%, respectively. SUNOSI Approximately 46,000 prescriptions were written for SUNOSI in the U.S. in the first quarter of 2025, representing an increase of 12% compared to the same period in 2024, and a decrease of 5% compared to the fourth quarter of 2024. Payer coverage for SUNOSI across all channels is approximately 83% of all covered lives. The proportion of lives covered for SUNOSI in the commercial and government channels are approximately 95% and 60%, respectively. SYMBRAVO In January 2025 , the U.S. Food and Drug Administration (FDA) approved SYMBRAVO for the acute treatment of migraine with or without aura in adults. SYMBRAVO represents a novel, multi-mechanistic approach to treating migraine that targets multiple pathways underlying a migraine attack, and is engineered with Axsome’s patented MoSEIC™ ( Molecular Solubility Enhanced Inclusion Complex ) rapid absorption technology. Preparations for the commercial launch of SYMBRAVO remain on track, with commercial availability anticipated in June 2025 . Development Pipeline Axsome is advancing an industry-leading neuroscience pipeline of multiple, innovative, late-stage, patent-protected product candidates addressing a broad range of serious psychiatric and neurological conditions. Recent and anticipated progress for key pipeline programs is summarized below. AXS-05 AXS-05 (dextromethorphan-bupropion) is Axsome’s novel, oral, investigational N-methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor being developed for the treatment of Alzheimer’s disease (AD) agitation and smoking cessation. AXS-05 has been granted FDA Breakthrough Therapy designation for AD agitation. Alzheimer’s Disease Agitation: In March 2025 , Axsome received formal pre-NDA meeting minutes from the FDA for AXS-05 in AD agitation, supporting a supplemental NDA (sNDA) submission. AXS-05 was granted Breakthrough Therapy designation for the treatment of AD agitation in June 2020 . The Company is on track to submit the sNDA in the third quarter of 2025. Smoking Cessation: Axsome plans to initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in 2025. Solriamfetol Solriamfetol is Axsome’s dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with EDS, binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD). Attention Deficit Hyperactivity Disorder: In March 2025 , Axsome announced positive topline results from the FOCUS Phase 3 trial evaluating the efficacy and safety of solriamfetol in ADHD in adults. The study achieved its primary and key secondary endpoints demonstrating substantial and statistically significant improvements in ADHD symptoms and disease severity with solriamfetol compared to placebo. Solriamfetol was safe and well tolerated in the trial, with a side effect profile consistent with the established safety profile of solriamfetol.The Company plans to initiate a Phase 3 trial of solriamfetol in ADHD in pediatric patients in 2025. Major Depressive Disorder: In April 2025 , Axsome announced topline results from the PARADIGM Phase 3 proof-of-concept trial evaluating the efficacy and safety of solriamfetol in MDD with and without excessive daytime sleepiness (EDS). In the prespecified subgroup of patients with severe EDS, solriamfetol led to numerically greater improvements in depressive symptoms. Solriamfetol was safe and well tolerated in the trial, with a side effect profile consistent with the established safety profile of solriamfetol.The Company plans to initiate a Phase 3 trial of solriamfetol in MDD patients with EDS in 2025. Binge Eating Disorder: Axsome is conducting the ENGAGE study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in BED. The Company anticipates topline results from the ENGAGE Phase 3 trial in 2026. Shift Work Disorder: Axsome is conducting the SUSTAIN study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in SWD in adults. The Company anticipates topline results from the SUSTAIN Phase 3 trial in 2026. SYMBRAVO SYMBRAVO (MoSEIC™ meloxicam-rizatriptan) is Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, selective COX-2 inhibitor and 5-HT1B/1D agonist indicated for the acute treatment of migraine with or without aura in adults. Migraine: In February 2025 , Axsome announced positive topline results from the EMERGE Phase 3 open-label trial of SYMBRAVO in patients experiencing inadequate response to oral CGRP inhibitors. The study achieved its primary endpoint by demonstrating statistically significantly greater migraine treatment response with SYMBRAVO compared to prior oral CGRP inhibitors, as assessed by the Migraine Treatment Optimization Questionnaire (mTOQ-4). In the trial, SYMBRAVO rapidly and substantially improved migraine pain and most bothersome symptoms. AXS-12 AXS-12 (reboxetine) is Axsome’s novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator being developed for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for narcolepsy. Narcolepsy: Axsome previously announced the completion of its clinical program of AXS-12 in patients with narcolepsy with cataplexy consisting of three controlled Phase 2 and Phase 3 efficacy trials and a long-term safety trial. AXS-12 achieved the primary endpoints and rapidly and substantially reduced cataplexy attacks, improved excessive daytime sleepiness, and improved cognitive function compared to placebo in all three efficacy trials (CONCERT, SYMPHONY, and ENCORE). The Company anticipates submitting an NDA to the FDA in the second half of 2025. AXS-14 AXS-14 (esreboxetine) is Axsome’s novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor being developed for the management of fibromyalgia. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine. Fibromyalgia: Axsome has submitted an NDA to the FDA for AXS-14 for the management of fibromyalgia. The Company anticipates the FDA’s decision on acceptance of the filing in the second quarter of 2025. Scientific Presentations In April 2025 , Axsome presented the positive topline results from the ACCORD-2 Phase 3 trial of AXS-05 in Alzheimer’s disease agitation and the SYMPHONY Phase 3 trial of AXS-12 in narcolepsy at the 2025 American Academy of Neurology (AAN) Annual Meeting. Additional presentations included findings from a new network meta-analysis comparing the efficacy of SYMBRAVO to oral CGRPs in the acute treatment of migraine. Corporate Update In March 2025 , Axsome announced that it resolved patent litigation with Hikma Pharmaceuticals USA, Inc. ( Hikma ) related to Hikma’s Abbreviated New Drug Application (ANDA) for a generic version of SUNOSI. The Company entered into a license and settlement agreement with Hikma , which permits Hikma to begin selling its generic version of SUNOSI on or after September 1, 2040 , if pediatric exclusivity is granted, or on or after March 1, 2040 , if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type. Anticipated Milestones Regulatory and Commercial: SYMBRAVO for the acute treatment of migraine, commercial launch ( June 2025 ) AXS-14 for fibromyalgia, FDA filing acceptance decision (2Q 2025) AXS-05 for Alzheimer’s disease agitation, sNDA submission (3Q 2025) AXS-12 for narcolepsy, NDA submission (2H 2025) Clinical Trial Topline Results: Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (2026) Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2026) Clinical Trial Initiations and Progress: Pivotal Phase 2/3 trial of AXS-05 in smoking cessation, initiation (2025) Phase 3 trial of solriamfetol in ADHD in pediatric patients, initiation (2025) Phase 3 trial of solriamfetol in MDD with EDS, initiation (2025) SYMBRAVO for the acute treatment of migraine, commercial launch ( June 2025 ) AXS-14 for fibromyalgia, FDA filing acceptance decision (2Q 2025) AXS-05 for Alzheimer’s disease agitation, sNDA submission (3Q 2025) AXS-12 for narcolepsy, NDA submission (2H 2025) Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (2026) Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2026) Pivotal Phase 2/3 trial of AXS-05 in smoking cessation, initiation (2025) Phase 3 trial of solriamfetol in ADHD in pediatric patients, initiation (2025) Phase 3 trial of solriamfetol in MDD with EDS, initiation (2025) Conference Call Information Axsome will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss its first quarter 2025 financial results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at axsome.com. A replay of the conference call will be available for approximately 30 days following the live event. About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States . Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. Investors: Mark Jacobson Chief Operating Officer(212) 332-3243mjacobson@axsome.com Media: Darren Opland Director, Corporate Communications(929) 837-1065dopland@axsome.com Source: Axsome Therapeutics, Inc.

The Digital Medicine Society (DiMe) announced it is partnering with Alcohol and Drug Services (ADS), Duke University, Google Fitbit, Morse Clinics, North Carolina Central University, Ōura, ProofPilot, Triangle CERSI and the University of North Carolina at Chapel Hill (UNC). The partnership aims to use data collected from consumer wearables to lower opioid use disorder (OUD) fatalities by creating interventions to help prevent relapse. According to a 2023 National Survey on Drug Use and Health by the Substance Abuse and Mental Health Services Administration (SAMHSA), among people aged 12 or older in 2023, 2.0 percent (or 5.7 million people) had an opioid use disorder in the past year. The partners will collaborate to describe and gather physiological signals and behavior traits, including heart rate, insomnia, physical inactivity and physiological stress, that can forecast relapse and be measured by wearable technologies. Researchers will use smartphones to collect mental health characteristics such as social isolation, patient-reported anxiety and depression. The data points train a tool to prevent opioid relapse. The team will proceed with research jointly led by Duke University's BIG IDEAs Lab and enlist patients for a pilot study to test the approach and ensure that their methods obtain optimal-quality data to develop the relapse prevention tool. "OUD is a complex challenge, and complex challenges require innovative collaboration and solutions," Candice Taguibo, associate program director of DiMe, said in a statement. "Our team is working to incorporate the many issues at play for those facing OUD – mental health, social support, treatment options, finances, access to technology, social stigma, and more - and build a tool that can meaningfully change the arc of OUD relapse and save thousands of lives." Shyamal Patel, senior vice president of science at Oura, asserted that leveraging technological advancements to develop evidence-based protocols for people living with OUD will position these interventions for success. "We're proud to support this study by providing continuous health monitoring and personalized, data-driven insights. This can empower individuals to take proactive steps in their recovery, potentially reducing the burden on our overstretched public health systems and offering a crucial tool in the fight against the opioid epidemic," Patel said in a statement. THE LARGER TREND In March, DiMe and Google Health introduced a free online course for medical professionals, researchers, administrators and innovators to learn the fundamentals of generative AI, large language models (LLMs) and the technologies' use cases in healthcare. The Generative AI for Healthcare course provides stakeholders with an understanding of LLMs and their applications in healthcare. In addition, participants will gain insights into generative AI technology, develop prompt engineering skills and explore how AI can support decision-making in clinical settings. In 2024, researchers from South Korea built machine learning-based models that can predict mood episodes using only sleep and circadian rhythm data from wearable devices. The team comprised researchers from the Institute for Basic Sciences (IBS), Korea Advanced Institute of Science and Technology (KAIST) and Korea University College of Medicine. In a study published in Nature's Digital Medicine journal, the research team first collected and analyzed 429 days' worth of sleep-wake data generated from Fitbit of 168 Korean patients with mood disorders, including major depression and bipolar disorders. The research team extracted 36 sleep and circadian rhythm features from this dataset, which were then applied to train models based on the machine learning library XGBoost to predict mood episodes. The findings revealed that the predictive models achieved 80%, 98% and 95% accuracy in predicting depressive, manic and hypomanic episodes, respectively. That same year, Oura closed a $200 million Series D funding round led by Fidelity Management & Research Company and Dexcom. The investment raised the company's valuation to $5.2 billion. In November 2024, Dexcom made a $75 million strategic investment in Oura and established a strategic partnership that enabled two-way data flow between Dexcom's continuous glucose monitor (CGM) and the Oura Ring. The investment at the time brought Oura's valuation to more than $5 billion.