fosmanogepix (APX001) / Basilea, Pfizer - LARVOL DELTA

Maximal Safe Resection and Targeted Intracavitary Therapy in Cladophialophora bantiana Brain Abscess: Illustration and Systematic Review. (PubMed, World Neurosurg) - "These findings support source-control centered multidisciplinary management of C. bantiana brain abscess, with highest survival observed in selected patients who underwent reported GTR. Repeat resection and Ommaya-enabled intracavitary amphotericin B may be considered in selected complex cases. Standardized reporting of operative extent, reoperation timing, and antifungal protocols will help refine care."

Journal • Review • CNS Disorders • Infectious Disease

Fusariosis in Mexico: cases and gaps to be addressed. (PubMed, Front Cell Infect Microbiol) - "Exceptions include a 10-year retrospective study published in 2023, and a Fusarium solani meningitis outbreak in Durango and Matamoros during 2022-2023, which together represent the largest global clusters of healthcare-associated fungal meningitis including an antifungal-resistant isolate in Matamoros that required investigational treatments such as Fosmanogepix...Additionally, 49 cases of invasive fusariosis have been reported across six states, mainly linked to burn injuries and hematological malignancies. Collectively, this review provides a national framework for understanding fusariosis and informs future research and public health strategies to address this emerging threat."

Journal • Review • CNS Disorders • Hematological Disorders • Hematological Malignancies • Infectious Disease • Keratitis • Ocular Inflammation • Oncology • Ophthalmology

Fosmanogepix Expanded Access Experience in Pediatric Patients ≤11 Years of Age with Invasive Mold Infections (IDWeek 2026) - No abstract available

Clinical • Infectious Disease

Pathogenesis and Triazole Resistance in Aspergillus fumigatus: A Narrative Review Across the Host Immune Spectrum and One Health Context. (PubMed, Infect Drug Resist) - "Novel antifungal agents, such as olorofim, fosmanogepix, rezafungin, ibrexafungerp, and T-2307, along with targeted delivery and immunomodulatory adjunct therapies for resistant aspergillosis, are also summarized. Major knowledge gaps persist regarding horizontal gene transfer of resistance mutations, cross-species transmission chains, and translational applications of environmental monitoring data. This review summarizes existing research bottlenecks and proposes integrated multi-sector prevention and control strategies from a One Health perspective to curb the growing threat of triazole-resistant aspergillosis."

Journal • Review • Gene Therapies • Pulmonary Disease • Respiratory Diseases • ARAF

Central Nervous System Aspergillosis: Advances in Diagnosis, Therapeutics, and Multidisciplinary Management (2026 Update). (PubMed, Mycoses) - "This review integrates the latest evidence to provide a timely and actionable resource for clinicians. It bridges gaps in existing guidelines by offering a multidisciplinary approach that addresses the complex management of CNS aspergillosis, with particular relevance for high-risk populations such as COVID-19 and immunocompromised patients."

IO biomarker • Journal • Review • Immunology • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Fungal Esophagitis: Molecular Insights Into Pathogenesis and Emerging Antifungal Strategies. (PubMed, Front Biosci (Landmark Ed)) - "While fluconazole remains the first-line agent for most cases, the increasing prevalence of non-albicans Candida species and drug resistance underscore the importance of alternative medications with different molecular targets. Agents such as the recently approved rezafungin as well as compounds such as ibrexafungerp and fosmanogepix, represent promising options for the treatment of refractory disease. This review synthesizes current advances in the molecular pathogenesis of fungal esophagitis, with particular emphasis on host-fungal interactions, antifungal resistance mechanisms, and novel treatment strategies. A deeper understanding of these processes is essential to improve management and to guide the development of innovative immunomodulatory and antifungal therapies."

IO biomarker • Journal • Review • Eosinophilic Esophagitis • Gastrointestinal Disorder • Human Immunodeficiency Virus • Immunology • Infectious Disease • Oncology • Solid Organ Transplantation • Transplantation • IL17A

A novel GWT1 A397T substitution combined with TAC1B F214I reduces manogepix susceptibility and fosmanogepix efficacy in Candida auris. (PubMed, Microbiol Spectr) - "The combined changes were also associated with a reduced response to fosmanogepix in an insect infection model. These findings show that changes affecting the drug target and drug efflux may act together to reduce antifungal activity and support monitoring for multiple pathways of reduced susceptibility."

Journal • Infectious Disease

Fusarium solani Skin and Soft Tissue Infection in a Patient With Chronic Sclerosing Skin Graft-vs-Host Disease: A Case Report. (PubMed, Am J Case Rep) - "In addition, this case outlines the high complexity of fusariosis treatment due to the capacity of this organism to develop multi-drug-resistance to mainline antifungals. This report illustrates clinical and radiographic improvement following implementation of fosmanogepix therapy in a severely immunocompromised patient with GVHD and complex multi-drug-resistant Fusarium infection."

Journal • Chronic Graft versus Host Disease • Dermatology • Graft versus Host Disease • Immunology • Infectious Disease • Scleroderma • Systemic Sclerosis • Transplantation

Molecular Mechanisms, Diagnosis, and Therapeutic Strategies of Antifungal Resistance in Filamentous Fungi. (PubMed, J Fungi (Basel)) - "Precision dosing guided by therapeutic drug monitoring, combination therapy, and the introduction of novel agents (including isavuconazole, rezafungin, fosmanogepix, and olorofim) are progressively improving clinical outcomes. Looking ahead, global surveillance and multisectoral collaboration are essential to deepen our understanding of resistance evolution, accelerate the clinical translation of novel diagnostic and therapeutic tools, and curb the global spread of resistance."

Journal • Review

Use of Expanded Access Fosmanogepix in Two Pediatric Patients With Rhino-Orbital-Cerebral Mucormycosis. (PubMed, Pharmacotherapy) - "Treatment with standard of care, including liposomal amphotericin B, micafungin, and azole antifungals along with nonpharmacologic measures, was unable to eradicate the infection. Each patient improved and more poorly tolerated antifungals were able to be discontinued. Both patients completed several months of fosmanogepix, tolerated therapy well, and survived their deadly infections."

Journal • Infectious Disease • Metabolic Disorders • Pediatrics

Novel antifungal agents for treating endemic mycoses: hope on the horizon? (PubMed, Curr Opin Infect Dis) - "Growing evidence suggests therapy for endemic mycoses may change substantially in the near future. New drugs and alternative treatment approaches have the potential to improve safety, tolerability, oral availability, drug-drug interaction profiles, and treatment duration, with important implications for both clinical care and future research."

Journal • Dermatology • Respiratory Diseases

Emerging antifungal agents in human medicine: Mechanisms, clinical progress, and future perspectives. (PubMed, Eur J Med Chem) - "This narrative review summarizes the current landscape of emerging antifungal therapies, focusing on ibrexafungerp 1, rezafungin 2, fosmanogepix 3, olorofim 4, opelconazole 5, and oteseconazole 6. However, important challenges remain, including limited activity against Mucorales for several agents, the potential emergence of future resistance, and the need for additional comparative clinical data and real-world experience. Overall, the expanding antifungal pipeline represents a major advancement toward more targeted and individualized antifungal therapy and may significantly reshape the future management of invasive and refractory fungal infections."

Journal • Review • Candidiasis • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Mutations in MRR1 that confer fluconazole resistance in C. parapsilosis and C. albicans confer cross-resistance to manogepix. (PubMed, Clin Microbiol Infect) - "Our findings demonstrate that fluconazole and manogepix cross-resistance in C. parapsilosis conferred by MRR1-activating mutations is mediated by Cdr1b and Mdr1b transporters. MRR1-activating mutations conferred cross-resistance, to a lesser degree, in C. albicans, but independent of drug transporters known to be regulated by Mrr1."

Journal • Candidiasis • ABCB1

Candida auris: a review of global epidemiology, multidrug resistance, and infection control in healthcare-associated outbreaks. (PubMed, Front Cell Infect Microbiol) - "Analysis of 80 peer-reviewed studies reveals five principal findings: (1) C. auris exhibits clade-dependent geographic distribution and resistance profiles-Clade I (South Asia) and Clade III show fluconazole resistance exceeding 90%, whereas Clade IV exhibits 44% resistance; echinocandin resistance varies significantly by clade and no resistance was detected in certain clades; amphotericin B resistance varies from no detected resistance to 46% depending on clade; and pan-resistant strains have emerged; (2) biofilm-associated C. auris cells (sessile cells) exhibit MBECs 2- to 4,119-fold higher than planktonic MICs, representing a major driver of persistent colonization; (3) novel antifungal agents, including ibrexafungerp, manogepix (the active moiety of fosmanogepix), and rezafungin, demonstrate promising in vitro activity against C. auris, with manogepix showing the highest overall antibiofilm activity (geometric mean MBEC of 5.9 μg/mL) and ibrexafungerp demonstrating..."

Journal • Review • Infectious Disease

Cladophialophora Bantiana Cerebral Phaeohyphomycosis in Solid Organ Transplant Recipients: First Case Treated with Fosmanogepix and Systematic Review of the Literature (ATC 2026) - "We report the first case in an organ transplant (OT) recipient successfully treated with fosmanogepix (FMGX) and review published cases associated with OT.* A renal transplant recipient with abscess underwent serial resections, Ommaya-directed amphotericin-B instillation, and received FMGX, a CNS-penetrant Gwt1 inhibitor, under compassionate use, due to voriconazole life-threatening toxicity. brain abscesses remain highly fatal, with just over one of four OT recipients cured. Outcomes improve with maximal-safe resection. FMGX is a promising agent for salvage or stepdown therapy, whereas in situ antifungals merit further investigation."

Clinical • Review • CNS Disorders • Infectious Disease • Solid Organ Transplantation • Transplantation

Manogepix demonstrates potent in vitro activity against Aspergillus, Coccidioides, Scopulariopsis/Microascus, Rasamsonia, and Purpureocillium species, including strains with in vitro resistance to other antifungals. (PubMed, Antimicrob Agents Chemother) - "Manogepix, the active moiety of the prodrug fosmanogepix, is a novel investigational agent in clinical trials that inhibits Gwt1, depleting glycosylphosphatidylinositol (GPI)-anchored mannoproteins critical for fungal cell wall integrity...Minimum effective concentrations (MECs) (manogepix and caspofungin) and minimum inhibitory concentrations (MICs) (amphotericin B, fluconazole, isavuconazole, itraconazole, posaconazole, and fluconazole) were determined by CLSI M38 broth dilution...Reduced or variable activity for manogepix was observed against Curvularia, Exophiala, and Exserohilum rostratum. Additional studies are warranted to determine if this potent in vitro activity translates into in vivo activity and enhanced clinical efficacy against infections caused by these fungal pathogens."

Journal • Preclinical • Infectious Disease

DISSEMINATED MUCORMYCOSIS: A DIAGNOSTIC AND THERAPEUTIC CHALLENGE (ESPID 2026) - "During reinduction (6thcycle), he was admitted with febrile neutropenia and abdominal pain and empirically started on cefepime, escalated to meropenem, teicoplanin, and oral vancomycin following clinical deterioration and clostridial toxin detection...Persistent fever led to initiation of liposomal amphotericin-B(5mg/kg/day)...Deterioration requiring invasive ventilation, prompted addition of amikacin and isavuconazole, and CT-scan evinced lung extension...Two attempts to discontinue amphotericin due to renal toxicity (posaconazole or isavuconazole monotherapy) failed, as IFD progressed...Learning Points/Discussion Ultimately,3.5 years after, amphotericin was successfully withdrawn, and fosmanogepix combined with isavuconazole led to improvement of hepatic lesions in 3months (fig.1). Sustained oral therapy allowed school attendance and preserved quality-of-life."

Infectious Disease

Invasive Fungal Sinusitis in Patients With Hematological Malignancies: A 20-Year Study From a Tertiary Academic US Hospital System. (PubMed, Open Forum Infect Dis) - "Amphotericin B (96.8%) and voriconazole (71.0%) were frequently used, and newer antifungals included isavuconazole (38.7%), olorofim (3.3%), and fosmanogepix (3.3%). Mortality was 22.6% at 1 month, 25.8% at 2 months, 32.3% at 3 months, 41.9% at 6 months, 54.8% at 1 year, 58.1% at 2 years, and 64.5% at 3 years. Despite novel therapies and aggressive surgical interventions, patients with IFS had high mortality."

IO biomarker • Journal • Acute Myelogenous Leukemia • Dermatology • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Otorhinolaryngology • Respiratory Diseases • Sinusitis • FLT3

FIRST REPORTED PAEDIATRIC USE OF OLOROFIM FOR REFRACTORY INVASIVE LOMENTOSPORA PROLIFICANS INFECTION FOLLOWING TRAUMATIC INJURY IN IRELAND (ESPID 2026) - "Despite combination therapy with Liposomal amphotericin B, Voriconazole, Terbinafine, and the novel agent Fosmanogepix, surgical specimens remained persistently culture-positive for Lomentospora prolificans.Given severe life-threatening infection, compassionate-release Olorofim therapy was initiated Learning Points/Discussion Olorofim, the first Orotomide-class antifungal, inhibits fungal dihydroorotate dehydrogenase, an essential enzyme in pyrimidine biosynthesis. This experience supports Olorofim as a promising therapeutic option for invasive mold infections with limited alternatives. To our knowledge, this represents the first reported use of Olorofim in a paediatric patient in Ireland"

Infectious Disease

Late-Breaking Abstract: INVASIVE FUSARIOSIS AFTER HSCT FOR RELAPSED ACUTE MYELOID LEUKEMIA IN A 8-YEAR OLD PATIENT: FIRST-IN-CHILD PHARMACOKINETIC EVALUATION OF COMPASSIONATE FOSFANOGEPIX ADMINISTRATION (ESPID 2026) - "Fosmanogepix (FMGX), pro-drug of active manogepix, and first member of "gepix" antifungal class, has demonstrated activity against Fusarium spp., wide tissue distribution and dose-proportional pharmacokinetics (PK) in adults, while no paediatric PK data have been...Acknowledgement: We thank Basilea for providing the drug and organizing PK analysis and isolate susceptibility to FMGX. We thank all the physicians, (micro)biologists and nurses, who helped with this case."

Clinical • Late-breaking abstract • PK/PD data • Infectious Disease

New Perspectives on Antimicrobial Agents: Fosmanogepix. (PubMed, Antimicrob Agents Chemother) - "Novel first-in-class antifungal agents have been recently approved (ibrexafungerp) or are currently being tested in clinical trials and are available via expanded access programs (olorofim, fosmanogepix). Novel gepix compounds have been developed and could make their niche in the future (e.g., APX2039, prodrug: APX2096, for cryptococcal meningitis, and APX2020, prodrug: APX2097, for coccidioidomycosis). This review discusses the future place of fosmanogepix in the antifungal armamentarium against IFIs."

Journal • Candidiasis • CNS Disorders • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Disseminated Fusariosis, Leukemia Cutis, and Acute Sinus Disease in Prolonged Neutropenia from Acute Myeloid Leukemia (CIS 2026) - "Prior therapies included avapritinib, decitabine/venetoclax, and enrollment in a vyxeos-gliteritinib clinical trial; he remained profoundly neutropenic (absolute neutrophil count [ANC] <20)...He was managed with liposomal amphotericin B, voriconazole, and terbinafine, along with meropenem and vancomycin. Due to Fusarium's high azole and amphotericin minimum inhibitory concentrations (MICs) at our institution, fosmanogepix was requested but anticipated to arrive in two weeks...Early recognition of the clinical triad of respiratory involvement, severe myalgia, and skin lesions may suggest Fusarium etiology in severely neutropenic patients. Successful management requires prompt diagnosis, appropriate combination antifungal therapy, and most critically, neutrophil recovery, which represents the single most important prognostic factor."

Acute Kidney Injury • Acute Myelogenous Leukemia • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Hepatology • Immunology • Infectious Disease • Leukemia • Musculoskeletal Pain • Myelodysplastic Syndrome • Nephrology • Neutropenia • Otorhinolaryngology • Pneumonia • Renal Disease • Respiratory Diseases • CSF2

Non-Candida fungal cholecystitis - an uncommon occurrence even in the right host. (PubMed, Eur J Clin Microbiol Infect Dis) - "At 6 weeks post-HCT, the patient underwent cholecystectomy and completed a course of fosmanogepix, leading to resolution of her infection. Here we review the published literature on non-Candida fungal cholecystitis, underlying risk factors and treatment."

Journal • Bone Marrow Transplantation • Gastroenterology • Hematological Disorders • Hematological Malignancies • Hepatology • Infectious Disease • Oncology • Transplantation

Refractory Candidozyma (Candida) auris-associated central nervous system infection in a postoperative neurosurgical patient. (PubMed, ASM Case Rep) - "Combination antifungal therapy with liposomal amphotericin B, flucytosine, and micafungin, later supplemented with posaconazole, was initiated but was complicated by significant toxicities requiring dose adjustments and stepwise discontinuation...Given persistent recovery of the organism, the clinical team initiated the US Food and Drug Administration Single Patient IND process to obtain fosmanogepix, an investigational antifungal agent, although the request was ultimately discontinued as the patient clinically stabilized. She was discharged on long-term oral voriconazole for antifungal suppression because of persistent CSF isolation of C. auris, multidrug resistance, and limited CNS penetration of previously administered antifungals. This case highlights diagnostic uncertainty, therapeutic challenges, and antifungal decision-making complexities following isolation of C. auris from CSF."

Journal • Infectious Disease • Musculoskeletal Pain • Oncology • Pain

Fosmanogepix treatment for coccidioidomycosis under an expanded access program. (PubMed, Clin Infect Dis) - P | "Coccidioidomycosis is an invasive fungal infection that can disseminate and cause severe disease. Fosmanogepix ("gepix"), a first-in-class antifungal available via expanded access (NCT06433128), was successful in 8/11 patients (meningitis, 6/8 [75%]; non-meningeal dissemination, 2/3 [66%]) and was well tolerated for a median treatment duration of 208 days."

Journal • CNS Disorders • Infectious Disease • Respiratory Diseases