Latest news with #TRD
Hamilton Spectator
4 days ago
- Automotive
- Hamilton Spectator
This Honda's not a rough-and-tumble off-roader, but a comfortable road warrior that can handle trails
Walking up to the all-new second gen. Honda Passport, I'm struck by its boxy, rugged looks. This thing looks reyady to hit the nearest dusty trail, I think to myself, as I climb into the driver's seat. But when I thunk the door shut behind me, I soon realize the 2026 Passport isn't some bare bones trail-runner. No, this SUV is built for wrapping its passengers in luxury, too. I'm sitting in a TrailSport Touring finished in Ash Green Metallic with a two-tone black and brown interior that that comes with brown perforated leather seats that have orange contrast stitching. Well, this sure is nice! There's more: A heated, leather-wrapped steering wheel; a 12.3-inch infotainment touchscreen and a 10.2-inch digital instrument cluster; Wireless Apple CarPlay and Wireless Android Auto; and some very nicely detailed TrailSport embroidery in the front headrests. On the outside, the Passport is focused on off-road driving. Think of TrailSport as Honda's answer to TRD (Toyota Racing Development), the in-house tuning-off-road arm of archrival Toyota. But unlike TRD, TrailSport isn't hardcore off-road; it's not for rock-crawling or running the Baja 1000, but is, instead, designed for trails you might encounter on the way to the cottage. With that in mind, Honda has chosen to offer the Passport in TrailSport trim only for Canada. This means items, such as an off-road tuned suspension, 18-inch wheels, and all-terrain tires, are standard on all trims. Same goes for the engine and transmission combo, which consists of a 3.5-litre, V6 paired with a 10-speed automatic. Power from the V6 is rated at 285 horsepower and 262 pounds-feet of torque, or motive force. All-wheel drive is standard, as is a towing capacity of 2,268 kilograms (5,000 pounds). The jacked-up look, which includes the word Passport stamped into its front and rear bodywork, is standard. So are front tow hooks and 8.3 inches of ground clearance. For a vehicle with an off-road focus, I'm struck by how comfortable the Passport is to drive on road. The cabin is quite quiet considering the all-terrains I'm riding around on. The V6 engine isn't built for performance, but it pushes the Passport along with authority. And the 10-speed automatic is a very smooth shifting gearbox. The '26 Passport receives Honda's updated all-wheel drive system. Known as i-VTM4, the system can handle 40 per cent more engine torque at the rear axle. Up to 70 per cent of torque can be sent to either axle and all of that torque can be sent to either the left or right rear wheel. To ensure good traction, torque distribution varies depending on driving conditions. There are seven drive modes, including two for off-road (sand and trail), and these the Passport's driving character. I kept to the normal setting for most of the week-long test, but also sampled eco and sport. The former is good for highway cruising and the latter makes zipping around town a little more exciting. But not much. The Passport is a family-focused SUV, after all. The Passport's on-road handling feels secure rain or shine. Braking and steering are responsive for a big SUV, and manoeuvring through tight spaces, such as a gas station parking lot, is a breeze. I will just add that I didn't drive it off-road. Living with the Passport is easy. Despite its many impressive features, including a 12-speaker Bose audio system and a fancy camera system, called TrailWatch, for off-roading, the Passport feels familiar. There are buttons for climate controls. Wipers and turn signals are on steering wheel stalks. And you don't have to go hunting around for the buttons and switches. Honda has left them where they belong. Including the volume knob. Hallelujah! Plus, all the SUV positives remain: Lots of room, plenty of storage and good towing capacity. There's not much room for nitpicking, but a few things rankle. These aren't flat-out negatives, so much as things to consider. First, the price. At $60K before taxes, the TrailSport Touring doesn't come cheap. Even the price for the base model is steep; it starts at $56,990. And, the Passport, like its three-row Pilot sibling, has no electrification. Not even a conventional gas hybrid, of the sort Honda offers with the CR-V. Finally, putting the Passport's gear shift on a row of buttons instead of a shift lever is a real miss. The buttons work fine, but they're not intuitive. A shift lever is better. Just like a round volume knob. But the Passport's pluses far outweigh its minuses and it's a winner. Type: Mid-size SUV, front-engine, all-wheel drive Engine: 3.5-litre V6; 285 horsepower; 262 pounds-feet of torque (motive force) Transmission: 10-speed automatic Fuel (Regular 87): 12.6 litres/100 km in the city; 9.9l/100 km on the highway; 11.4l/100 km combined Cargo: 1,246 litres, or 44 cubic feet; 2,356l, or 83.2 cu. ft. Price: $60,540; $60,540, as tested, plus $2,000 freight
Yahoo
27-06-2025
- Business
- Yahoo
Psychedelic: Compass Pathways achieves primary endpoint in COMP360 trial
In this week's 'Psychedelic,' The Fly's recurring series focused on psychedelic stock news, The Fly looks back on a primary endpoint achievement, a clinical site addition and additional development candidate data. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter COMPASS PATHWAYS ACHIEVES PRIMARY ENDPOINT IN COMP360 TRIAL: Compass Pathways (CMPS) announced Monday the achievement of the primary endpoint in the ongoing Phase 3 COMP005 trial, the first of two Phase 3 trials evaluating COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression. The primary endpoint is the difference in change from baseline in the Montgomery-Åsberg Depression Rating Scale scores between the active treatment group and the placebo group at week 6. A single dose of COMP360 25 mg versus placebo demonstrated a highly statistically significant reduction in symptom severity with a p-value of <0.001 and a clinically meaningful difference of -3.6 in change at the primary endpoint. The company plans to discuss these preliminary COMP005 data with the U.S. Food and Drug Administration, which has not yet reviewed the data. The ongoing Phase 3 COMP005 trial is the first study of an investigational, synthetic psilocybin, and the first classic psychedelic to report Phase 3 efficacy data. This randomized, double-blind, placebo-controlled study, which dosed 258 participants with TRD across 32 sites in the United States, aims to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD. KBased on the latest review of the data for the 005 and 006 studies, safety findings are consistent with previous studies of COMP360 and there are no new or unexpected safety findings. From this review of the data, there is no evidence of a clinically meaningful imbalance between treatment arms in suicidality in either study. "The positive top-line results at week 6 from the COMP005 trial underscore the innovative potential of psilocybin treatment in mental health care for which Compass Pathways continues to pave the way," said Kabir Nath, CEO. "We are proud of this significant progress, which reflects our scientific rigor, operational excellence and steadfast commitment to serving patients living with TRD. We eagerly anticipate further insights once we have the full dataset, and also look forward to findings from COMP006, which will explore the efficacy of two fixed doses. We remain focused on our goal of transforming the landscape of mental health treatment." Following the report, Evercore ISI downgraded Compass Pathways (MNMD) initiation, durability is a key component for commercial success and this will remain a question with relatively unclear durability in the Phase 2b and a weaker effect at 6 weeks here, the analyst said. Meanwhile, H.C. Wainwright said that meeting the primary endpoint in the Phase 3 COMP005 trial in treatment-resistant depression marks 'a historic first for a psychedelic therapy.' In addition to this readout representing the first-ever positive Phase 3 efficacy data for a classic psychedelic, it positions COMP360 as 'a potential first-in-class treatment in a large, underserved depression market,' said the analyst, who reiterated a Buy rating and $45 price target on the shares. Stifel acknowledged that the 3.6 point MADRS delta between drug-vs-placebo for COMP360 was 'a little lighter than expected,' but argued that the magnitude of the stock reaction is 'significantly overdone'. The COMP360 data represents 'a clearly positive result from a regulatory perspective,' and the effect-size is 'actually pretty good for a treatment-resistant population,' according to the analyst, who added that it is 'simply not clear' that effect size is a major driver of commercial success in neuropsychiatry. The firm has a Buy rating and $11 price target on Compass shares. Additionally, Canaccord said the weakness in Compass Pathways following the release of top-line results from its eagerly-awaited COMP005 Phase 3 trial is a buying opportunity. Canaccord believes updates from the FDA could eventually move the stock and there is no change to their model pending additional data. Canaccord reiterated its Buy rating and $15 price target on Compass Pathways shares. BTIG lowered the firm's price target on Compass Pathways to $7 from $12 but kept a Buy rating on the shares. The firm noted that COMP360 represents the 'very careful development of a mediocre drug' relative to other options in the psychedelic and neuro-plastic pipeline, the analyst said. CLEARMIND ADDS ISRAELI CLINICAL SITE TO AUD TRIAL: Clearmind Medicine (CMND) announced Monday the addition of Tel Aviv Sourasky Medical Center in Tel Aviv, Israel, as an additional clinical site for its ongoing Phase I/IIa clinical trial evaluating CMND-100, a proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder. This expansion follows the recent enrollment of the first patient in the trial. The study at Tel Aviv Sourasky Medical Center will be led by Dr. David Zeltser, Director of the Emergency Medicine Department. Tel Aviv Sourasky Medical Center joins other institutions participating in the trial, including Yale School of Medicine's Department of Psychiatry and Johns Hopkins University School of Medicine. The inclusion of Tel Aviv Sourasky Medical Center further strengthens Clearmind's clinical network, enhancing the trial's capacity to evaluate the safety, tolerability, and pharmacokinetic profile of CMND-100, while also exploring its potential to reduce alcohol cravings and consumption in patients with AUD. 'We are pleased to welcome Tel Aviv Sourasky Medical Center to our Phase I/IIa clinical trial, alongside esteemed partners like Yale and Johns Hopkins,' said Adi Zuloff-Shani, CEO. 'The enrollment of our first patient earlier this month was a pivotal moment, and expanding our clinical trial to additional leading clinical sites like TASMC underscores our commitment to addressing the global burden of AUD, which affects millions and accounts for 2.6M deaths annually.' ENVERIC REPORTS ADDITIONAL DATA ON EB-003: On Tuesday, Enveric Biosciences (ENVB) unveiled additional data indicating that its lead development candidate, EB-003, acts as an agonist of the serotonin receptor 5-HT1B, in addition to its other previously disclosed receptor engagement activities. The 5-HT1B receptor is a recognized therapeutic target for treating several central nervous system conditions, including major depressive disorder, Parkinson's disease, migraines, and cluster headaches. The study results demonstrated agonism of 5-HT1B by EB-003 and added to the existing receptor engagement data supporting that EB-003 acts as a partial agonist of the 5-HT2A receptor, which is key to the compound's potential ability to elicit neuroplastogenic effects without inducing adverse hallucinogenic outcomes. EB-003 is currently in preclinical development, with IND-enabling activities planned to continue through 2025. 'The 5-HT1B receptor, found predominantly in the frontal cortex, basal ganglia and hippocampus, is a validated therapeutic target of some well-known CNS drugs,' said Joseph Tucker, CEO. 'Enveric previously announced positive pharmacology, in vitro safety and oral bioavailability data of EB-003, including achieving therapeutically relevant brain exposure in rodent models. The newly revealed ability to target 5-HT1B illustrates EB-003's differentiated and multifaceted mechanism of action and broadens its utility and the range of potential target indications to pursue in future development.' SILO PHARMA ENTERS LOI FOR JV WITH HOTH: Silo Pharma (SILO) announced Wednesday that it has entered into a non-binding letter of intent to form a strategic 50:50 joint venture with Hoth Therapeutics (HOTH) to develop and commercialize a potential treatment for obesity and metabolic disease based on technology Hoth has exclusively licensed from the U.S. Department of Veterans Affairs that was co-developed by the VA and Emory University. The novel therapeutic platform centers on glial cell line-derived neurotrophic factor, a VA-invented biologic with demonstrated anti-obesity effects and metabolic regulation in preclinical models. The platform is protected under U.S. Patent No. 10,052,362 and targets multiple high-burden conditions, including non-alcoholic fatty liver disease, type 2 diabetes, and central obesity. 'With obesity at epidemic levels and no curative therapies available, we believe the VA's biologic GDNF is potentially a game-changer,' said Eric Weisblum, CEO. 'We believe that our potential JV collaboration with Hoth aligns with our mission to accelerate groundbreaking science into human trials.' HOPE THERAPEUTICS TO ACQUIRE INTEREST IN COHEN: HOPE Therapeutics, a wholly-owned subsidiary of NRx Pharmaceuticals (NRXP), announced Thursday the signing of a binding Letter of Intent to purchase a 49% interest in Cohen and Associates, founded by Dr. Rebecca Cohen. Cohen is expected to serve as a foundational clinic for HOPE in the Sarasota-Bradenton region of western Florida. The clinic offers a full range of treatments for suicidal depression, PTSD and other CNS disorders, including ketamine, Spravato, Transcranial Magnetic Stimulation as well as medication management. 'We are delighted to welcome Rebecca and her team to the HOPE family. Her extensive experience with neuroplastic therapies, combined with compassionate patient care exemplify our culture of bringing HOPE to life,' said Jonathan Javitt and Matthew Duffy, Co-CEOs of HOPE. Additionally on Monday, NRx Pharmaceuticals announced filing for the newly-announced FDA Commissioner's National Priority Voucher program on behalf of NRX-100, its patent-pending, preservative-free formulation of ketamine for intravenous use. Concurrent with the CNPV process, the company is preparing a citizen petition to seek withdrawal of preservative-containing forms of ketamine, based on the toxicity associated with the benzethonium chloride preservative used in the historic formulation. The company has also filed a patent on its preservative-free manufacturing process. 'NRx is highly encouraged by the newly-announced Commissioner's National Priority Voucher Program, and believes that NRX-100 meets each of the criteria for acceptance,' said Jonathan Javitt, CEO. 'As previously determined by FDA, our products are innovative treatments that address the current health crisis of suicidal depression and PTSD, and address an unmet medical need. We will be seeking New Drug Approval for NRX-100 in the treatment of suicidal depression and PTSD. The FDA's announcement has now validated our company's focus on manufacturing and CMC by identifying CMC as a pre-requisite to the CNPV program. The timelines announced for the CNPV program are consistent with NRx's previous guidance of FDA decisions by year-end 2025. Our application under the CNPV program is accretive to the Abbreviated New Drug Application filed last week for preservative-free ketamine, for which we are seeking priority review.' OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Bright Minds (DRUG), Cybin (CYBN), Entheon Biomedical (ENTBF), Filament Health (FLHLF), GH Research (GHRS), Incannex (IXHL), MIRA Pharmaceuticals (MIRA), Mydecine Innovations (MYCOF), Numinus Wellness (NUMIF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC) and Seelos Therapeutics (SEEL). Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on CMPS: Disclaimer & DisclosureReport an Issue Mike Davis to become CDER deputy director, Pink Sheet's Gingery says Compass Pathways price target lowered to $7 from $12 at BTIG Compass Pathways weakness a buying opportunity, says Canaccord Compass Pathways Achieves Phase 3 Trial Success Compass Pathways downgraded to In Line from Outperform at Evercore ISI Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Medscape
24-06-2025
- Health
- Medscape
Psilocybin Safe, Effective for TRD: Phase 3 Data
A single dose of a synthetic form of psilocybin known as COMP360 (Compass Pathways) is both statistically significant and clinically meaningful in reducing treatment-resistant depression (TRD) in a new phase 3 trial, its manufacturer announced in a press release. Topline results from the ongoing COMP005 trial showed that a single 25-mg dose of the investigational drug was associated with a greater reduction in symptom severity on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 6 weeks than matching placebo, meeting the study's primary endpoint. Additionally, there were 'no unexpected safety findings and no clinically meaningful imbalance in suicidal ideation between treatment and placebo arms,' the company added. This is 'the first study of an investigational, synthetic psilocybin, and the first classic psychedelic, to report phase 3 efficacy data,' the company said. The results are important for patients with TRD who do not respond to currently approved and available treatment options, Guy Goodwin, MD, chief medical officer at Compass, said in the release. 'This achievement provides hope that they can finally receive appropriate care and live the life they deserve,' Goodwin added. Ongoing Research COMP360 is a synthetic and proprietary formulation of psilocybin. As reported by Medscape Medical News, results presented at the 2023 European Psychiatric Association Congress from a phase 2 study assessing a single 25-mg dose of the drug were associated with improvements of core symptoms in patients with TRD. It has also appeared to be effective for bipolar depression and for anorexia nervosa in two separate small studies. COMP005 is the first of two ongoing and parallel-running phase 3 trials assessing the investigational drug. In it, 258 patients with TRD were enrolled across 32 US sites and randomly assigned to receive one administration of either the active drug at a dose of 25 mg or matching placebo. The newly released results are from the first part of the trial, which included blinding through 6 weeks. From baseline to 6 weeks, the participants who received the active treatment had a significantly greater reduction in symptom severity on the MADRS compared to those who received placebo ( P < .001). In addition, there was a mean score treatment difference of -3.6 (95% CI, -5.7 to -1.5), demonstrating a clinically meaningful reduction, the company noted. The trial's data, which were reviewed by an independent Data Safety Monitoring Board, showed no new or unexpected safety findings and were consistent with those from previous COMP360 studies. Part 2 of the ongoing trial will be evaluating results blinded through week 26, and part 3 will contain open-label treatment from week 26 to week 52. 'We eagerly anticipate further insights once we have the full dataset,' Kabir Nath, Compass' chief executive officer, said in the release. For now, the company reported that it is planning to discuss these preliminary results with the US Food and Drug Administration. In addition, the ongoing phase 3 COMP006 trial is aiming to enroll 568 participants from North America and Europe and will assess two fixed doses of the active treatment. Compass is expecting to receive 26-week data during the second half of 2026.
Yahoo
06-06-2025
- Health
- Yahoo
Denovo Biopharma Announces Formation of Neuroscience Scientific Advisory Board to Advance Precision Medicine in Depression
- Scientific Advisory Board brings together distinguished experts in neuroscience to support Denovo's CNS development programs, including the Phase 3-ready lead program, biomarker-guided DB104 (liafensine) in treatment-resistant depression (TRD) - SAN DIEGO, June 06, 2025 (GLOBE NEWSWIRE) -- Denovo Biopharma LLC, a pioneer in applying precision medicine to development of innovative drugs, today announced the formation of its neuroscience-focused Scientific Advisory Board (SAB) comprised of distinguished experts in the field. The SAB will be chaired by Charles B. Nemeroff, M.D., Ph.D., Chair and Professor of the Department of Psychiatry and Behavioral Sciences at Dell Medical School at The University of Texas at Austin. Dr. Nemeroff served as president of the American College of Psychiatrists and the American College of Neuropsychopharmacology, and is past-president of the Anxiety and Depression Association of America (ADAA). 'We are extremely honored to welcome such a distinguished group of scientific leaders to join our efforts at Denovo Biopharma as we work towards addressing a major unmet need in the psychiatry field with a novel precision medicine,' said Wen Luo, Ph.D., Chief Executive Officer of Denovo Biopharma. 'As we prepare our lead asset, DB104, to enter a biomarker-guided Phase 3 study in TRD, we believe their guidance will be instrumental in shaping both our clinical development strategy and our regulatory path forward. We are thankful for their support and look forward to collaborating as we work to advance a first-in-class, potentially transformative therapy for patients with TRD.' Other members of Denovo's neuroscience Scientific Advisory Board include: Stephen Brannan, M.D., is a neuroscience drug development expert with over 15 years of industry experience. He most recently served as Chief Medical Officer at Karuna Therapeutics, where he was instrumental in the development of CobenfyTM for the treatment of schizophrenia, which was later acquired by Bristol Myers Squibb for $14 billion. Prior to Karuna, Dr. Brannan was the Therapeutic Head of Neuroscience at Takeda and Vice President for Clinical Research and Medical Affairs at Forum Pharmaceuticals. Dr. Brannan has been active in the development of multiple important central nervous system treatments including Cymbalta®, Exelon Patch®, Trintellix®, and Vagal Nerve Stimulation for TRD during his tenures at Forum, Takeda, Novartis, Cyberonics, and Eli Lilly. Sanjay Mathew, M.D., is Professor of Psychiatry and Behavioral Sciences, Director of Mood and Anxiety Disorders Program, and Vice Chair for Research at Baylor College of Medicine. He is currently ADAA's President-Elect and Chief Medical Officer. Dr. Mathew is a leading expert in the areas of experimental therapeutics and pathophysiology of TRD, suicide, and PTSD. About DB104 (biomarker-guided liafensine) Liafensine is a first-in-class triple reuptake inhibitor targeting transporters for serotonin, norepinephrine, and dopamine. It was licensed from Albany Molecular Research, Inc. (now Curia) and was previously developed by Bristol-Myers Squibb (BMS), who had conducted two large Phase 2b clinical trials in non-selected TRD patient population. Denovo's unique artificial intelligence (AI) and whole genome sequencing (WGS)-based Denovo Genomic Marker (DGM™) biomarker platform allowed discovery of a novel genetic biomarker at the ANK3 gene, with a strong correlation of ANK3-positive status with liafensine's efficacy in the BMS studies. Denovo's ENLIGHTEN Phase 2b study results prospectively demonstrated the use of ANK3 as a predictive biomarker for liafensine's efficacy in TRD patients, a first for genetic biomarkers in psychiatry. About Denovo Biopharma Denovo Biopharma LLC is a clinical-stage biopharmaceutical company that uses novel biomarker approaches to execute efficient clinical trials in targeted patient subpopulations to increase the probability of success. Denovo has seven late-stage drugs in its pipeline addressing major unmet medical needs in central nervous system diseases and oncology, most of which are first in class drugs with global rights. Visit for additional information. Investor Contact: Stephen Jasper Gilmartin Group stephen@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
04-06-2025
- Business
- Business Wire
LivaNova Initiates Process with U.S. Centers for Medicare and Medicaid Services for Reconsideration of National Coverage for VNS Therapy for Treatment-Resistant Depression
LONDON--(BUSINESS WIRE)--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced it has initiated the process with the U.S. Centers for Medicare and Medicaid Services (CMS) to seek reconsideration of national Medicare coverage for VNS Therapy™ in unipolar patients with treatment-resistant depression (TRD). The first step in the process for making a National Coverage Determination (NCD) is the submission of a draft formal request for CMS reconsideration. "We have reached an important point in our pursuit to obtain national coverage for VNS Therapy for unipolar patients with depression that is difficult to treat,' said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. Five critical articles featuring outcomes from in-depth data analyses on primary and select secondary endpoints in the RECOVER study have recently been published in or accepted by peer-reviewed journals, and the totality of data presented in these articles serves as the basis of the Company's request to CMS. The company believes these articles satisfy the Coverage with Evidence Development (CED) requirement of sharing peer-reviewed, publicly accessible results of pre-specified outcomes measured in the RECOVER study. In addition to the five articles, the request for coverage reconsideration includes strong 24-month clinical outcomes from the unipolar cohort of the RECOVER clinical study that demonstrate the substantial retention of benefits and the durability of VNS Therapy over time. 'We have reached an important point in our pursuit to obtain national coverage for VNS Therapy for unipolar patients with depression that is difficult to treat,' said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. 'Our follow-on analyses of the RECOVER unipolar data demonstrate that symptoms alone may not be the sole source upon which to gauge the clinical impact of treatment. Instead, symptoms, function, and quality of life taken together present a more complete picture of treatment effectiveness. We are eager to review this powerful data with CMS during the reconsideration process.' Final Articles in Critical Series Analyze RECOVER Primary and Select Secondary Endpoint Data Two new in-depth analyses 1,2 on primary and select secondary endpoints in the RECOVER trial have recently been published and a third accepted by peer-reviewed journals. Prior to these articles, two initial articles were published in Brain Stimulation 3,4 in December 2024, completing the series of five critical articles in total. Collectively, the articles highlight the significant unmet need of this markedly ill population with TRD. The RECOVER data demonstrates that VNS Therapy improves symptoms, function, and quality of life in TRD patients over time. These are outcome measures identified as clinically relevant by CMS. Depressive symptoms, daily function, and quality of life taken together, as a novel composite metric, present a more complete picture of treatment effectiveness than symptoms alone. The fifth and final critical publication utilizes this composite metric and demonstrates favorable response to VNS Therapy in TRD patients who had previously failed multiple treatments, including interventional therapies. Researchers found that patients with previous ECT or TMS treatment had statistically significant and clinically meaningful benefits with active VNS Therapy. Notably, VNS Therapy is the only treatment that has demonstrated therapeutic effects in patients who previously failed ECT. 24-Month VNS Therapy Data Show Durability, Increasing Response Across All Outcome Measures New top-line 24-month data from the RECOVER study show that, across all outcome measures, VNS Therapy patients in the active arm of RECOVER experienced a substantial durability of benefit from month 12 to month 24. Of those patients who at 12 months had achieved clinically meaningful benefit, the median durability of benefit was 81.3% across all outcome measures at the 24-month assessment. This is considerable durability for these unipolar patients who, at baseline in the RECOVER study, had failed more than 13 antidepressant treatments on average. Observing all VNS Therapy patients in the active treatment arm of the RECOVER trial from month 12 to month 24, researchers also found improvement in all outcome measures, with the median rate of response, or clinically meaningful benefit, increasing from 40.2% at month 12 to 51.6% at month 24. 'There is no clinical evidence to demonstrate that there are any other therapies, including pharmacotherapies and interventional therapies such as electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS), that can claim this profound level of sustained durability and increasing benefit,' said A. John Rush, M.D., Professor Emeritus at Duke-National University of Singapore Medical School who has spent 25 years researching VNS Therapy for TRD and served as Chief Consultant on the RECOVER trial. 'These are critical findings that offer hope to treatment-resistant depression patients and their loved ones, who have struggled for years to find effective options. Patients not only stay better – they also continue to get better.' Improvement in suicidality shows statistically significant separation as early as month three LivaNova conducted additional in-depth analyses specifically evaluating suicidality for the active treatment arm of RECOVER through the first 12 months of therapy. Using a composite suicidality measure 5, results showed an estimated 43% higher odds of achieving meaningful improvement in suicidal ideation symptoms versus the control arm. Of specific interest, there was separation between the active and control arms on the composite suicidality metric as early as month three. Additionally, the observed separation was consistent throughout the initial 12 months. 'The composite suicidality outcome is especially encouraging because we can see a separation between the active and control arms so early in the study,' said Charles Conway, M.D., director of the Washington University Resistant Mood Disorders Center at Washington University School of Medicine in St. Louis. Conway is the RECOVER study's lead investigator. 'We're eager to further evaluate the suicidality data beyond 12 months and, in the context of the overall durability story of VNS Therapy, determine whether this benefit also continues to improve over time.' While not included in the initial submission to CMS, the suicidality data will be provided in detail to the agency upon publication in a peer-reviewed journal. RECOVER launched in 2019 as part of a CED framework per the CMS NCD process. For the unipolar cohort of RECOVER, enrollment was completed in March 2023, and the 12-month follow-up for those patients was completed in March 2024. No new safety issues were identified in the study. About RECOVER LivaNova's VNS Therapy™ System has been approved for the treatment of depression since earning CE Mark in 2001 and premarket approval (PMA) from the U.S. Food and Drug Administration in 2005. RECOVER stands for A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression. The largest randomized clinical study of its kind, RECOVER is examining up to 1,000 patients ages 18 or older who have unipolar or bipolar depression that is difficult to treat. A total of 493 adults with at least four documented unsuccessful attempts with antidepressant treatments participated in the unipolar cohort of the RECOVER study. The double-blind, randomized controlled study is assessing how VNS Therapy can offer patients relief from their depressive symptoms and improve quality of life. It is being carried out at up to 100 leading hospitals and medical centers across the United States. About VNS Therapy for Depression The VNS Therapy™ System, Symmetry™, is U.S. Food and Drug Administration-approved and indicated in the U.S. for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. The most commonly reported side effects are voice alteration or hoarseness, prickling or tingling in the skin, increased coughing, shortness of breath, and sore throat. Infection is the most common complication of the surgical procedure. Important safety information is available at References Conway CR, et al. An examination of symptoms, function, and quality of life as conjoint clinical outcome domains for treatment-resistant depression. Journal of Mood & Anxiety Disorders. April 14, 2025. DOI: 10.1016/ Sackeim HA, et al. Characterizing the effects of vagus nerve stimulation on symptom improvement in markedly treatment-resistant major depressive disorder: A RECOVER trial report. July 1, 2025. DOI: 10.1016/ Conway CR, et al. Vagus nerve stimulation in treatment-resistant depression: A one-year, randomized, sham-controlled trial. Brain Stimulation. Dec. 18, 2024. DOI: 10.1016/ Rush AJ, et al. Effects of vagus nerve stimulation on daily function and quality of life in markedly treatment-resistant major depression: Findings from a one-year, randomized, sham-controlled trial. Brain Stimulation. Dec. 18, 2024. DOI: 10.1016/ The composite suicidality metric was created by adding a suicidality-specific question from each of MADRS, Quick Inventory of Depressive Symptomology–Self Report, or QIDS-SR, and Quick Inventory of Depressive Symptomology–Clinical, or QIDS-C. About LivaNova LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing solutions in select neurological and cardiac conditions. Headquartered in London, LivaNova employs approximately 2,900 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals, and healthcare systems worldwide. For more information, please visit Safe Harbor Statement This news release contains 'forward-looking statements' concerning the Company's goals, beliefs, expectations, strategies, objectives, plans, underlying assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding the RECOVER study, the VNS Therapy™ System, Symmetry™, and the likelihood that the Company is successful in obtaining national Medicare coverage for its VNS Therapy™ System. Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company's most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.
