Liafensine

Expands DB104 Intellectual Property Portfolio until at least 2043 SAN DIEGO, April 29, 2026 (GLOBE NEWSWIRE) -- Denovo Biopharma, a pioneer in applying precision medicine in central nervous system (CNS) diseases, today announced that the U.S. Patent and Trademark Office issued U.S. patent number 12,612,261, titled “ Compositions and methods for assessing the efficacy of inhibitors of neurotransmitter transporters .” The patent is directed for the use of DGM4™, a novel genetic biomarker discovered through the company’s AI and big data based Denovo Genomic Marker (DGM™) platform, for the company’s DB104 (liafensine) program for treatment-resistant depression (TRD). “The patent issuance for the DGM4 biomarker represents a significant step in strengthening our DB104 intellectual property portfolio and reinforces our mission to redefine the treatment of TRD, a difficult-to-treat CNS disorder that impacts millions of patients globally,” said Wen Luo, PhD, Denovo’s Chief Executive Officer. “Building on the success of our Phase 2b study and Fast Track Designation by the FDA, receiving this patent represents another milestone for DB104 and underscores its potential to transform how we address TRD through a patient-specific, biomarker-driven approach.” Unlike most of the approved companion diagnostics that are based on known biomarkers, DGM4 is a completely novel biomarker discovered by Denovo using the archived samples of patients treated with liafensine. The issuance of this patent provides the DB104 intellectual property portfolio protection until 2043, offering longer market exclusivity than conventional composition of matter-based patent protections as liafensine is already in Phase 3 clinical development. About Treatment-Resistant Depression Major depressive disorder (MDD) is a common mental health disorder that impacts an estimated 280 million people worldwide. In the United States alone, approximately 21 million adults have had at least one major depressive episode. Approximately one-third of MDD patients fail to respond to oral antidepressants and are classified as having treatment-resistant depression (TRD), generally defined as an inadequate response to at least two medications. Despite having a significant negative impact on the lives of those affected and one of the highest economic burdens of all psychiatric disorders, TRD has limited treatment options and represents a major unmet medical need. About DB104 (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) for treatment-resistant depression (TRD). BMS had conducted 14 clinical trials which proved the superior safety of liafensine but failed to show efficacy in non-biomarker-selected TRD populations. After discovery of the DGM4 (aka ANK3) biomarker associated with liafensine’s efficacy, Denovo’s ENLIGHTEN Phase 2b pivotal trial prospectively demonstrated robust efficacy and favorable safety pro liafensine in ANK3-positive patients with TRD. The results of ENLIGHTEN trial was published in JAMA Psychiatry (DOI: 10.1001/jamapsychiatry.2025.2416). About ANK3 (DGM4) Biomarker The ANK3 gene, which encodes a scaffolding protein primarily expressed in the nervous system, plays an important role in neuronal signaling through modulation of cell membrane proteins and is linked to psychiatric diseases including bipolar disorder and depression. DGM4 is a single nucleotide polymorphism (SNP) located in the ANK3 gene Denovo discovered as a pharmacogenomic biomarker associated with liafensine’s efficacy via its unique artificial intelligence (AI) and whole genome scan-based DGM biomarker discovery platform. 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. Investor Contact: Stephen Jasper Gilmartin Group stephen@gilmartinir.com

SAN DIEGO, Feb. 11, 2026 (GLOBE NEWSWIRE) -- Denovo Biopharma LLC, a pioneer in applying precision medicine to development of innovative drugs, today announced a partnership with Orygen to initiate a Phase 2 investigator-initiated-trial (IIT) to study DB103 (pomaglumetad methionil) for first-episode psychosis (FEP) or clinical high risk (CHR) of psychosis. The study is being led by Professor Patrick McGorry, M.D., and sponsored by Orygen in Parkville, Australia. “Despite the introduction of antipsychotic medications over a decade ago, treatment options for a substantial minority of young patients with FEP or CHR of psychosis remain limited,” said Patrick McGorry, M.D., lead study investigator. “As a novel drug targeting the glutamate system, which plays a critical role in psychotic disorder, pomaglumetad presents an option to fulfill this unmet medical need. Given its excellent safety profile, it may be uniquely effective by addressing the shortcomings of other antipsychotics such as weight gain and prolactin elevation.” “Although pomaglumetad did not achieve statistically significant efficacy in a broad schizophrenia patient study, a subset of patients early in disease exhibited significantly greater improvement,” said Wen Luo, Ph.D., Denovo's Chief Executive Officer. “The study of pomaglumetad in patients with psychosis marks an important step forward in our mission to develop innovative and transformative therapies for psychiatric conditions. We are honored to work with the world-renowned team at Orygen, internationally recognized for its scientific leadership and extensive expertise in youth mental health research.” This open-label, Phase 2, feasibility trial will investigate the safety, tolerability, and acceptability of administering 2 daily doses of 40 mg of pomaglumetad methionil, over the duration of 12 weeks in young people aged 18-25 years with insufficient response to a single first-line antipsychotic treatment in FEP patients or failure of remission of CHR-positive symptoms and functional recovery in CHR patients. The study will also determine whether pomaglumetad can reduce total symptomatology and dysfunction. The study has been approved by the Royal Melbourne Hospital Human Research Ethics Committee (Project 2024.289). About DB103 (pomaglumetad methionil) Pomaglumetad methionil is a first-in-class psychiatric drug that selectively acts on the glutamic acid mGlu2/3 receptor and has no cross-reaction with other receptors in the central nervous system, and hence, can avoid some usual side effects of psychiatric drugs currently on the market. It was licensed from Eli Lilly (LLY), who had completed 37 clinical trials with more than 3,800 subjects. Pomaglumetad methionil has shown significant promise when applied to the right subpopulation of patients through personalized medicine or targeted therapy. 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. A positive pivotal study of DB104 (liafensine) in patients with treatment-resistant depression who carry a Denovo-discovered novel ANK3 biomarker was recently published in JAMA Psychiatry. Visit for additional information. Investor Contact: Stephen Jasper Gilmartin Group stephen@gilmartinir.com