Iterum launches ORLYNVAH, first oral penem antibiotic in U.S., for uUTI

Iterum Therapeutics plc

FDA approved ORLYNVAH in Oct 2024; commercial launch announced Aug 20, 2025.
First oral penem antibiotic in U.S.; first new branded uUTI product in >25 years.
57% of initial uUTIs resistant to at least one antibiotic class per 2024 study.
Copay savings program allows eligible patients to get ORLYNVAH for as low as $25.
CEO cites urgent need for new oral therapies amid rising antibiotic resistance.

item 7.01item 8.01item 9.01

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.