Pharmaceutical Executive Daily: FDA Approves Utebzi and Capvaxive

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today's Pharmaceutical Executive Daily, Biogen announces its second acquisition of 2026, a deal worth up to $1 billion for private immunology biotech RayThera, FDA approves Utebzi as the first and only oral carbapenem antibiotic for adults with complicated urinary tract infections, and FDA expands the indication for Merck's Capvaxive to include children and adolescents aged 2 through 17 with chronic medical conditions at increased risk for pneumococcal disease.

Biogen has entered a definitive agreement to acquire RayThera, a private San Diego-based biotechnology company focused on discovering and developing small molecule therapies in immunology, for up to $1 billion consisting of an upfront payment and predominantly milestone payments tied to clinical and regulatory achievements. RayThera's undisclosed portfolio includes multiple anti-inflammatory small molecule candidates targeting immune-mediated conditions across a range of indications, with the lead asset expected to enter Phase I clinical development in early Q3 2026

FDA has approved Utebzi for the treatment of complicated urinary tract infections, including pyelonephritis, in adults who have limited or no alternative oral treatment options, making it the first and only oral carbapenem antibiotic approved in the United States. The approval, based on data from the Phase III Pivot-PO trial in 1,690 hospitalized adults demonstrating non-inferiority of oral Utebzi to intravenous imipenem-cilastatin, resolves a fundamental clinical gap in which patients with multidrug-resistant complicated UTIs were previously required to be hospitalized for IV carbapenem treatment or managed through a PICC line at an infusion center.

Finally, FDA has approved an expanded indication for Merck's Capvaxive to include children and adolescents aged 2 through 17 who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at increased risk for pneumococcal disease, making Capvaxive the only pneumococcal conjugate vaccine specifically indicated and studied in the United States for this patient population. The approval is based on Phase III Stride-13 trial data in 874 pediatric patients that demonstrated Capvaxive was non-inferior to PPSV23 for the 12 shared serotypes and induced statistically significantly greater immune responses than PPSV23 for the nine serotypes unique to Capvaxive, including several that cause a disproportionate share of invasive pneumococcal disease in children with conditions such as diabetes, chronic heart disease, chronic kidney disease, chronic liver disease, and chronic lung disease.

Thanks for listening to Pharmaceutical Executive Daily. For more updates and in-depth analysis, visit PharmExec.com.