Xanomeline Tartrate/Trospium Chloride

Bristol Myers has multiple data readouts and new clinical trials for Cobenfy to "maximize the opportunity beyond schizophrenia," CEO Chris Boerner said. Cobenfy, the novel antipsychotic drug that Bristol Myers Squibb obtained from a $14 billion acquisition, could have a problem.The drug recently failed as an adjunctive treatment in a phase 3 trial for inadequately controlled schizophrenia, and, as Goldman Sachs analyst Asad Haider noted, new-to-brand prescription growth appears to be moderating as the second quarter nears its end.But Bristol Myers CEO Chris Boerner and Chief Commercialization Officer Adam Lenkowsky don’t see things that way.“We’ve got very good feedback from physicians in terms of what they’re seeing on positive symptoms, negative symptoms and … the cognitive benefits,” Boerner said at the Goldman Sachs Annual Global Healthcare Conference this week. “What we have now is a number of programs that either will begin reading out or that we’ll be initiating to ensure that we can maximize the opportunity beyond schizophrenia.”BMS continues to interrogate the failed Arise trial to understand why some patients derived benefits in the adjunctive setting, but the trial has “zero impact” on Cobenfy’s commercial uptake “in the short term or in the long term,” Lenkowsky said.BMS has not ascribed any sales projection to Cobenfy’s adjunctive use, and the trial’s investigators are the only doctors who are really aware of the setback, Lenkowsky said. Nevertheless, two “experienced psychiatrists” recently told Leerink Partners that they still expect Cobenfy to be used as an adjunctive schizophrenia therapy, given that no treatments are currently approved in that setting and psychiatrists have limited options, according to a May 5 note. The experts did caution, however, that payers may reject coverage for adjunctive treatment due to the trial failure. Cobenfy’s launch is tracking against expectations, having surpassed 30,000 total scripts following an FDA approval in late September, according to Lenkowsky.However, a Leerink Partners analysis of IQVIA data showed that Cobenfy’s weekly total scripts stayed largely flat, at 1,800, for most of May, before dipping to about 1,700 toward the end of the month thanks to the Memorial Day holiday.Lenkowsky acknowledged that it’s going to take time to continue to increase the number of prescribers and to get doctors to break the decades-old habit of using generic dopamine D2 receptor antagonists to treat schizophrenia.“We’ve got a very robust plan in place right now,” the commercial chief said. “In the field organization, we’ll be upsizing our teams in the near future as well to make sure we’ve got the right reach and frequency.”The company is also running a study to help inform physicians on the best way to switch patients from traditional antipsychotics and how to manage some of the side effects, he noted.BMS believes Cobenfy will see strong uptake “in the back end of the year,” Lenkowsky said, citing positive feedback from doctors, “particularly around the efficacy profile and, most notably, the cognitive benefits.”But, apparently, not all responses from doctors have been positive. One of Leerink’s experts said he hasn’t observed remarkable efficacy for Cobenfy among patients who haven’t responded to other schizophrenia treatments, the setting in which he has primarily been using the drug because of prior authorization requirements from insurance.“He questioned whether Cobenfy’s real-world efficacy will turn out to be robust enough to justify its [twice-daily] dosing and high cost,” Leerink analysts summarized in the May 5 note, adding that the expert argued that clinical trials tend to cherry-pick patients, making real-world outcomes notably different from clinical results. Meanwhile, looking to expand Cobenfy beyond schizophrenia, BMS currently has three studies in Alzheimer’s disease psychosis—a large market, as about half of the six million patients with Alzheimer’s suffer from hallucinations and delusions, Lenkowsky said.The first of the trio, Adept-2, is expected to read out this year. While doctors have reported a positive surprise on Cobenfy’s real-world tolerability in schizophrenia, Leerink analysts flagged that Alzheimer’s patients are more sensitive to side effects in the digestive system. BMS lowered the trospium component of the two-drug combo in Adept-2, a move that the Leerink team argued could raise gastrointestinal tolerability issues.Beyond Alzheimer’s psychosis, BMS is launching seven new phase 3 trials in Alzheimer’s agitation, Alzheimer’s cognition, bipolar disorder, irritability associated with autism and a new formulation. That means Cobenfy could have a data readout every single year from now to the end of the decade, setting the drug up to be a “meaningful contributor to growth for the company in the back end of the decade and beyond,” Lenkowsky said.

- 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 www.denovobiopharma.com for additional information. Investor Contact: Stephen Jasper Gilmartin Group stephen@gilmartinir.com