Takeda Pharmaceutical Company Limited announced that the data from the pivotal Phase 3 SOLSTICE clinical trial of LIVTENCITY™ (maribavir, TAK-620) in post-transplant refractory† CMV infections with or without resistance‡ (R/R) were published in the journal of Clinical Infectious Diseases (CID). The manuscript is available online and will be included in a future print edition of CID, the official peer-reviewed journal of the Infectious Diseases Society of America.1 The SOLSTICE study primary endpoint was met, with 55.7% (131/235) of adult patients on LIVTENCITY achieving confirmed CMV DNA level below the lower limit of quantification (The key secondary endpoint of the composite achievement of CMV DNA level § at Week 8 maintained through Week 16 was met, with a higher proportion of patients in the LIVTENCITY arm (18.7%, 44/235) meeting the endpoint compared to those on conventional antiviral therapies (10.3%, 12/117); adjusted difference [95% CI]: 9.5% [2.02 to 16.88]; P=0.013. Rates of treatment-emergent adverse events (TEAEs) were similar between groups (LIVTENCITY, 97.4%; conventional antiviral therapies, 91.4%). A higher proportion of subjects in the conventional antiviral therapies group discontinued study medication due to an adverse event (32%, 37/116) compared to the LIVTENCITY group (13%, 31/234). One patient per group had a fatal treatment-related treatment-emergent adverse event; however, within the LIVTENCITY group, the event was assessed by the sponsor as being unrelated to LIVTENCITY. All-cause mortality was similar in each treatment group (conventional antiviral therapies 11%, 13/117; LIVTENCITY 11%, 27/235). LIVTENCITY is currently approved for use only in the U.S. for the treatment of adults and pediatric patients (12 years or older and weighing at least 35 kg) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet. CMV is a beta herpesvirus that commonly infects humans; serologic evidence of prior infection can be found in 40%-100% of various adult populations. CMV typically resides latent and asymptomatic in the body but may reactivate during periods of immunosuppression. Serious disease may occur in individuals with compromised immune systems, which includes patients who receive immunosuppressants associated with various types of transplants including hematopoietic cell transplant (HCT) or solid organ transplant (SOT). Out of the estimated 200,000 adult transplants per year globally, CMV is one of the most common viral infections experienced by transplant recipients, with an estimated incidence rate between 16-56% in SOT recipients and 30-70% in HCT recipients.