Iterum Therapeutics shares rise 10.64% after-hours after FDA approval of ORLYNVAH and upcoming Q3 earnings report.

Iterum Therapeutics (NASDAQ: ITRM) rose 10.64% in after-hours trading following the FDA approval of its lead compound, ORLYNVAH™, for drug-resistant UTIs, and a 62.5% year-over-year improvement in its Q3 2025 EPS estimate to -$0.09. The approval of sulopenem, along with QIDP designations for seven additional indications, highlights regulatory progress for the antibiotic developer. While concerns about pipeline diversity and commercial scalability persist, the earnings improvement and recent regulatory milestone likely bolstered investor optimism. The upcoming Q3 earnings report on November 14, which may address production and pricing strategies, further positioned the stock for post-market strength as investors anticipate clarity on scalability challenges.